Metallic suture, monofilament
MD-3224266 — Metallic suture, monofilament- DEVICEOPOEIA technical monograph
Metallic Suture, Monofilament is a sterile or non-sterile, non-absorbable surgical suture consisting of a single strand of biocompatible metallic wire, typically manufactured from surgical-grade stainless steel or titanium. It is intended for the approximation, fixation, ligation, or closure of tissues where high tensile strength, minimal tissue reactivity, and long-term mechanical support are required. The device may be supplied with or without an attached surgical needle. The monofilament construction provides excellent strength and resistance to degradation while minimizing bacterial harboring compared to multifilament alternatives.
Lifecycle Status
Emerging
Growth
Mature
Legacy
Obsolescent
Discontinued
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Innovation Category
Conventional
Incremental
Advanced
Novel
Disruptive
Breakthrough
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Regulatory Information
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Device Class
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Class IIb/C devices are moderate-to-high risk medical devices requiring increased regulatory oversight, risk management, and technical documentation.
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Class C |
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Intended Use
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Regulatory intended use defines the specific medical purpose and clinical application of the device.
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A non-absorbable metallic monofilament suture intended for the approximation, fixation, ligation, or closure of soft tissues and/or bone structures during surgical procedures where permanent mechanical support and high tensile strength are required. The device may be supplied with or without an attached surgical needle. |
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Indications for Use
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Indications for use describe the medical conditions or situations for which the device is intended.
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Indicated for use in abdominal wound closure, intestinal anastomosis, hernia repair, sternal closure, orthopedic cerclage procedures, tendon repair, and other surgical applications requiring permanent tissue or bone approximation.. |
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Contraindications
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Contraindications specify situations where the device should not be used due to safety concerns.
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Contraindicated in patients with known hypersensitivity or allergy to stainless steel, titanium, nickel, chromium, or other constituent metallic materials. Contraindicated where radiotransparency of the implanted material is required or where the presence of metallic material may interfere with diagnostic imaging procedures. |
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Prescription Status
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Prescription status indicates whether the device is restricted to professional or regulated use.
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Prescription Use Only (Rx). Intended to be used only by, or under the supervision of, qualified healthcare professionals trained in surgical wound closure techniques. |
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Sterility Status
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Sterile devices require validated sterilization processes, packaging integrity validation, and microbiological controls.
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Sterile |
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Reusable / Single Use
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Reusable devices require validated cleaning, disinfection, and reprocessing procedures to maintain safety and performance.
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Single Use |
Device Description
| Device Overview | Metallic Suture, Monofilament is a non-absorbable surgical suture composed of a single strand of biocompatible metallic wire, typically surgical stainless steel or titanium. It is designed to provide permanent tissue or bone approximation, fixation, and support in surgical procedures where exceptional tensile strength and long-term mechanical stability are required. The device may be supplied as a ligature wire or as a needle-attached suture for tissue closure applications.
Due to its high strength, minimal elongation, and resistance to degradation within the physiological environment, metallic monofilament sutures are commonly used in procedures such as sternal closure, orthopedic cerclage fixation, tendon repair, abdominal wall closure, and other surgical applications requiring durable, non-absorbable wound support. The monofilament construction minimizes tissue drag and reduces the potential for bacterial retention compared with braided metallic alternatives. As a long-established surgical technology, metallic monofilament sutures remain an important option in specialized surgical disciplines where permanent fixation and mechanical reliability are critical to clinical outcomes. They are available in various wire diameters, lengths, configurations, and needle combinations to accommodate different anatomical sites and procedural requirements. |
| Principle of Operation | The device functions as a permanent mechanical load-bearing element that maintains tissue approximation or structural fixation by transmitting and sustaining tensile forces across the surgical site. Its metallic monofilament construction provides high tensile strength, dimensional stability, and resistance to in vivo degradation, thereby preserving mechanical support throughout the healing period and beyond when permanent fixation is required. |
| Technology Type | Mechanical Fixation Technique |
| Mechanism of Action | Maintains tissue approximation or structural fixation through sustained mechanical tensile support, preventing separation or displacement of tissues and enabling healing and stabilization. |
| Novel Features / Technology | None |
| Components | Metallic Monofilament Suture Strand Surgical Needle (Optional) Needle-Suture Attachment (Optional) |
| Accessories | Suture needles (when supplied separately), needle holders, wire twisters, wire tensioning instruments, wire cutters, cerclage passers, and other surgical instruments intended to facilitate placement, fixation, or removal of the metallic suture. |
| Operating Environment | Sterile surgical environment and in vivo physiological environment of the human body. |
| Shelf Life | Typically 3–5 years when supplied sterile and stored in accordance with the manufacturer's instructions. Actual shelf life is manufacturer-specific and must be supported by packaging and stability validation data. |
| Clinical Workflow | Assessment of surgical repair requirements → Selection of suitable metallic monofilament wire characteristics (material, diameter, and configuration) → Surgical placement across tissues, vessels, tendons, or skeletal structures requiring approximation or stabilization → Generation and maintenance of tensile forces to establish tissue apposition or structural fixation → Formation of a stable mechanical construct through wire securing techniques → Intraoperative confirmation of alignment, fixation integrity, and load distribution → Sustained post-operative mechanical support throughout healing, remodeling, or osseous consolidation → Continued implantation or elective removal based on clinical judgment. |
| User Profile | Qualified surgeons and trained healthcare professionals experienced in surgical tissue approximation, ligation, and fixation procedures. |
Materials & Composition
| Material Composition | Austenitic Stainless Steel Titanium, Titanium Alloy (Ti-6Al-4V ELI) |
| Active Components | Not applicable. |
| Coatings | Siliconized surface treatment |
| Biological Origin | Non-biological origin materials. |
| Absorbable / Non-Absorbable | Non-absorbable. |
| Drug-Eluting | No |
| Tissue Contact Duration | Implant Tissue/Bone Contact |
| Implant Duration | Long-Term (>30 Days)/Permanent |
| MRI Compatibility | MR Conditional (manufacturer and configuration specific). |
| Latex Content | Latex-free. |
| DEHP / Phthalates | Not Present |
| Nanomaterials | Not present. |
| Animal Tissue Derivatives | None. |
Risk & Safety
| Hazard Categories | Biological, material-related, mechanical, implantation-related, MRI-related, and use-related hazards. |
| Known Risks | Wound dehiscence, infection, tissue trauma, wire breakage, hypersensitivity reactions, and fixation failure. |
| Residual Risks | Local tissue response, discomfort, imaging artifacts, and rare allergic reactions. |
| Warnings | For use by trained surgical professionals only. Do not reuse or resterilize. |
| Precautions | Avoid kinking or excessive manipulation. Use appropriate surgical technique. |
| Adverse Events i
Undesirable clinical outcomes associated with device use that may require investigation, vigilance assessment, and regulatory reporting depending on applicable reporting criteria and event severity.
| Wound dehiscence, infection, fixation failure, wire fracture, implant migration, allergic/hypersensitivity reaction, foreign body reaction, delayed healing, chronic pain, reoperation, or device explantation. |
ISO 24971 / ISO 14971 Risk Evaluation Matrix
Matrix Scale:
Probability of Occurrence of Harm (P): P1 (Low) → Pmax (High)
Severity of Harm (S): S1 (Negligible) ↑ Smax (Catastrophic)
Acceptable (Broadly Acceptable)
ALARP (As Low As Reasonably Practicable)
Action Required (Risk Reduction / Verification)
Unacceptable (Mandatory Risk-Benefit Analysis)
ISO 14971 Assessment Summary
Select Matrix Cell
| Probability of Harm (P) | -- |
| Severity of Harm (S) | -- |
| Risk Index (P × S) | -- |
| Initial Risk Evaluation | -- |
--
ISO 24971 Risk Control Hierarchy
Verification & Residual Risk Actions
Risk Evaluation Methods
Device Performance Attributes
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Attribute
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Device performance attributes describe the functional, mechanical, and material characteristics that influence the clinical effectiveness, safety, durability, and long-term performance of the device. These attributes are used to evaluate whether the device can consistently achieve its intended purpose under expected conditions of use.
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Specification | ||||||||||||||||||||||||||||||||
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Primary Performance Function
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Defines the principal clinical function the device is expected to perform. This establish the primary therapeutic or surgical role of the device and serves as the basis for performance evaluation.
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Tissue approximation, ligation, compression, and structural fixation. | ||||||||||||||||||||||||||||||||
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Tensile Strength
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Tensile strength determines the ability of the suture to withstand pulling forces without failure. Adequate tensile strength is essential to maintain tissue approximation and structural support during healing.
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High tensile strength designed for long-term mechanical support and fixation.
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Mechanical Stability
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Mechanical stability reflects the ability of the device to maintain structural integrity and functional performance under physiological loading conditions throughout its intended implantation period.
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Maintains structural integrity and fixation under physiological loads. | ||||||||||||||||||||||||||||||||
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Fatigue Resistance
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Implanted devices are exposed to repetitive biomechanical stresses. Fatigue resistance evaluates the ability of the device to resist crack formation, weakening, or fracture during cyclic loading.
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Resistant to cyclic mechanical stresses encountered during normal physiological activity. | ||||||||||||||||||||||||||||||||
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Corrosion Resistance
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Corrosion resistance is important for preserving material integrity and minimizing degradation, ion release, or loss of mechanical performance in the physiological environment.
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High resistance to corrosion and material degradation in vivo. | ||||||||||||||||||||||||||||||||
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Flexibility and Handling
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Flexibility influences surgical handling, placement, and adaptation to anatomical structures. Appropriate flexibility helps facilitate implantation while maintaining device integrity.
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Designed to permit controlled manipulation and placement during surgical procedures. | ||||||||||||||||||||||||||||||||
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Load-Bearing Capability
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Load-bearing capability evaluates the ability of the device to transfer and sustain tensile forces across tissues or anatomical structures without functional failure.
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Minimum Load-Bearing Capability / Minimum Ultimate Load Before Failure (Metallic Sutures)
Reference: USP/NF Nonabsorbable Surgical Suture requirements for Class III Metallic Sutures (e.g., Stainless Steel Surgical Sutures).
Typical Performance Characteristics
Informative values representing typical engineering and clinical performance characteristics of metallic surgical sutures; actual performance may vary based on alloy type, wire diameter, braid configuration, manufacturing process, and intended clinical application.
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Dimensional Stability
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Dimensional stability assesses the ability of the device to retain its physical dimensions and mechanical properties throughout storage and implantation.
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Maintains dimensional and mechanical characteristics during long-term implantation. | ||||||||||||||||||||||||||||||||
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Tissue Approximation Capability
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This reflects the effectiveness of the device in maintaining tissue apposition and preventing separation during the healing process.
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Provides sustained tissue apposition and stabilization. | ||||||||||||||||||||||||||||||||
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Radiographic Visibility
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Visibility under radiographic imaging may assist clinicians in postoperative assessment, localization, and evaluation of fixation integrity.
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Typically radiopaque and visible under conventional radiographic imaging. |
Clinical & Performance
| Clinical Endpoints i
Clinical endpoints are predefined measures used to assess whether a device achieves its intended clinical objectives. For fixation and tissue approximation devices, endpoints commonly include healing outcomes, fixation integrity, anatomical stability, complication rates, and the need for reintervention.
| Maintenance of tissue approximation or fixation stability, successful healing, preservation of anatomical alignment, absence of wound dehiscence, and achievement of the intended surgical outcome. |
| Anticipated Eventsi
Expected and risk-assessed clinical outcomes associated with normal device use. When appropriately communicated through risk controls, labeling, warnings, and risk-benefit analysis, these events are generally not reportable unless associated with device failure, unexpected occurrence, or increased severity.
| Transient pain, edema, localized inflammatory response, tissue remodeling, scar formation, and temporary discomfort normally associated with surgical implantation and healing. |
| Human Factors i
Human factors describe user-device interactions that may influence safety, effectiveness, usability, and clinical performance, including training, handling, ergonomics, and prevention of use-related errors.
| Safe and effective use depends on device ergonomics, appropriate surgical training, correct device selection, proper wire handling, controlled tension application, secure fixation techniques, and adherence to aseptic surgical practices. |
Standards & Compliance
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ISO 14971
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International standard specifying the process for identifying, evaluating, controlling, and monitoring risks associated with medical devices throughout their lifecycle.
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ISO 13485
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International quality management system standard for organizations involved in the design, manufacture, distribution, and servicing of medical devices.
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IS 9165
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Surgical instruments — Needles, suture.
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ISO 5832-1
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Wrought stainless steel
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ISO 10993-1
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Provides the framework for biological evaluation of medical devices within a risk management process based on the nature and duration of patient contact.
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ISO 10993-2
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Specifies animal welfare requirements and ethical considerations for biological evaluation studies involving animals.
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ISO 10993-3
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Provides methods for assessing genotoxicity, carcinogenicity, and reproductive toxicity associated with medical device materials.
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ISO 10993-4
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Provides guidance for evaluating interactions between medical devices and blood, including hemocompatibility testing.
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ISO 10993-5
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Specifies methods for in vitro assessment of the cytotoxic potential of medical device materials.
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ISO 10993-6
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Provides methods for evaluating local tissue effects and biological responses following implantation.
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ISO 10993-7
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Specifies allowable limits and evaluation methods for ethylene oxide sterilization residuals on medical devices.
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ISO 10993-9
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Provides a framework for identifying and quantifying degradation products generated from medical device materials.
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ISO 10993-10
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Specifies methods for assessing skin sensitization and irritation potential of medical device materials.
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ISO 10993-11
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Provides methods for evaluating acute, subacute, subchronic, and chronic systemic toxicity associated with medical devices.
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ISO 10993-12
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Specifies requirements for sample preparation and reference materials used during biological evaluation testing.
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ISO 10993-13
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Provides methods for identification and quantification of degradation products generated from polymeric medical device materials.
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ISO 10993-15
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Provides methods for identification and quantification of degradation products released from metallic materials and alloys used in medical devices.
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ISO 10993-16
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Provides principles and methods for toxicokinetic studies of degradation products and leachable substances.
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ISO 10993-17
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Provides methods for establishing allowable limits for leachable substances and evaluating toxicological safety margins.
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ISO 10993-18
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Provides requirements for chemical characterization of medical device materials and constituent substances.
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ISO 10993-19
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Provides methods for physicochemical, morphological, and topographical characterization of medical device materials.
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ISO 10993-20
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Provides principles and methods for immunotoxicology testing and evaluation of medical devices.
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ISO 10993-22
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Provides guidance on biological evaluation considerations for medical devices incorporating nanomaterials.
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ISO 10993-23
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Specifies methods for evaluating irritation potential associated with medical device materials and extracts.
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ISO 11135
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Requirements for development, validation, and routine control of ethylene oxide sterilization processes for medical devices.
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ISO 11137
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Requirements for validation and control of radiation sterilization processes for medical devices.
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ISO 15223-1
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Specifies symbols used in medical device labeling to communicate safety and regulatory information.
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ISO 20417
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Specifies information to be supplied by the manufacturer for safe identification and use of medical devices.
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ASTM F138 / ASTM F139
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Material specifications for implant-grade stainless steel commonly used in metallic surgical sutures and implantable medical devices.
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ASTM F67 / ASTM F136
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Material specifications for commercially pure titanium and titanium alloy used in implantable medical devices.
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ISO 7153-1
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Specifies metallic materials suitable for surgical instruments and related medical applications.
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ASTM F899
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Specifies requirements for wrought stainless steels commonly used in surgical instruments and surgical needle manufacture.
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ASTM F1840
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Provides standardized terminology, nomenclature, and definitions for surgical suture needles, supporting consistent specification, design, testing, and communication throughout the medical device lifecycle.
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Sustainability Profile
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Environmental Impact
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Assessment of the device's environmental footprint throughout manufacturing, distribution, use, and disposal.
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Moderate – Lifecycle Dependent |
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Recyclable Content
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Percentage of device materials that can be recovered, recycled, or reused through established recycling processes.
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Not Applicable - Stainless steel and titanium are durable metals with established recycling streams; however, recovery of an implanted medical device is generally not practical after use. |
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Reusable Components
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Components designed for repeated use after validated cleaning, maintenance, or refurbishment.
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Recycling or reuse of used devices may be limited by biological contamination and healthcare-waste requirements. |
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Battery Sustainability
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Assessment of battery longevity, replaceability, recycling options, and environmental considerations.
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Not Applicable |
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Hazardous Substance Status
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Presence or absence of restricted substances regulated under environmental legislation.
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The device shall not contain CMR substances of Category 1A/1B and specified endocrine-disrupting substances present above 0.1% w/w |
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Carbon Footprint Category
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Estimated lifecycle greenhouse gas impact associated with manufacturing, transportation, operation, and disposal.
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Medium or If Manufacturer have Lifecycle Assesemnt Specific data |
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Packaging Sustainability
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Evaluation of recyclable, biodegradable, or reduced-waste packaging materials.
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Recyclable Packaging Materials The combined concentration of lead (Pb), cadmium (Cd), mercury (Hg), and hexavalent chromium (Cr(VI)) in packaging and packaging components shall not exceed 100 mg/kg (100 ppm) |
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End-of-Life Disposal
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Recommended disposal pathway for device components after end of service life.
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Used/Implanted/Removed device: regulated healthcare/sharps waste. Unused/expired device: dispose according to applicable healthcare-waste requirements. Metal Recovery: Metallic recycling may be considered only through authorized processes where permitted. Possible after authorized treatment/decontamination and where legally permitted |
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Circular Economy Potential
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Potential for refurbishment, remanufacturing, reuse, material recovery, and waste reduction.
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Low to Moderate — Material Recovery Dependent. |
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Sustainability Rating
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Composite sustainability assessment based on environmental, material, lifecycle, and circular economy factors.
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6 / 10
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represents the minimum indicative sustainability rating based on its durable metallic materials and potential for material recovery, balanced against single-use status, sterile packaging, sterilization requirements, manufacturing impacts, limited post-use recycling, and non-biodegradability. The rating may be increased or decreased when manufacturer-specific lifecycle assessment, carbon-footprint, packaging, recycled-content, or other verified sustainability data are available.
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Deviceopoeia Sustainability Insight:
Sustainability expectations for medical devices are increasingly recognized across global regulatory jurisdictions. Deviceopoeia presents sustainability parameters and attributes that may be achievable using currently available technologies, materials, manufacturing practices, and environmental approaches. These indicators are provided for informational purposes only and do not represent regulatory certification or verified performance. Actual sustainability performance may vary, and manufacturers may demonstrate higher or different sustainability achievements based on product design, manufacturing processes, supporting evidence, and validated claims.
Deviceopoeia Intelligence
Regulatory Complexity
6 / 10
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High rating indicates high compliance burden involving software controls, clinical evidence, post-market surveillance, and extensive technical documentation.
Standards Coverage
92%
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reflects coverage based on the standards currently identified for performance, biological evaluation, material of construction, sterilization, risk management, quality management, and labeling. The remaining gap primarily reflects jurisdiction-specific requirements, packaging and sterile-barrier requirements, configuration-specific standards, and manufacturer-specific specifications that cannot be universally assigned to the generic device category.
Device Interoperability & Dependency
The extent to which a medical device, IVD, software, accessory, component, consumable, instrument, or system is intended to operate independently, interact with other technologies, exchange information, or rely upon associated devices, software, components, consumables, reagents, or infrastructure to achieve its intended purpose.
Lifecycle Status
Innovation Category
Comparable Devices
Competing Technologies
Alternative technological approaches or platforms developed to achieve the same medical, diagnostic, or therapeutic objective using different mechanisms or methodologies.
Alternative Therapies
Other medical treatments, procedures, diagnostics, or interventions that may be used instead of the selected device for managing the same condition or clinical purpose.
Technology Class Peers
Devices belonging to the same technological category or engineering class, sharing similar operating principles, technical architecture, or device type characteristics.
