Polyolefin/fluoropolymer suture, multifilament (polyethylene)

MD-3226268 — Polyolefin/fluoropolymer suture, multifilament (Polyethylene)- DEVICEOPOEIA technical monograph

Class C Sterile Non-Active Implantable

Deviceopoeia ID: MD-3226268
EMDN Codes: H01020201 • H0102010104 • H0102010299
UNSPSC: 42312201

A Polyolefin/Fluoropolymer Multifilament Polyethylene Suture is a sterile, non-absorbable surgical suture composed primarily of polyethylene fibers arranged in a braided or multifilament configuration and optionally coated with polyolefin or fluoropolymer materials to improve handling characteristics, reduce tissue drag, and enhance knot security. The suture is intended for approximation, ligation, and repair of soft tissues where long-term tensile strength retention is required.

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

Device Class i Class IIb/C devices are moderate-to-high risk medical devices requiring increased regulatory oversight, risk management, and technical documentation.	Class C
Intended Use i Regulatory intended use defines the specific medical purpose and clinical application of the device.	The Polyolefin/Fluoropolymer Multifilament Polyethylene non-absorbable surgical suture is intended for approximation, ligation, and repair of soft tissues where long-term tensile strength retention is required. The device may be supplied with or without an attached surgical needle.
Indications for Use i Indications for use describe the medical conditions or situations for which the device is intended.	Indicated for use in Skin closure, Fascial closure, Tendon and ligament repair, Cardiovascular tissue approximation, and General soft tissue ligation and approximation.
Contraindications i Contraindications specify situations where the device should not be used due to safety concerns.	The device should not be used: Where absorbable wound support is clinically indicated. In patients with known hypersensitivity to Polyethylene, polyolefin, fluoropolymer, or related materials. In situations requiring rapid loss of tensile strength.
Prescription Status i Prescription status indicates whether the device is restricted to professional or regulated use.	Prescription Use Only (Rx). Intended to be used only by, or under the supervision of, qualified healthcare professionals trained in surgical wound closure techniques.
Sterility Status i Sterile devices require validated sterilization processes, packaging integrity validation, and microbiological controls.	Sterile
Reusable / Single Use i Reusable devices require validated cleaning, disinfection, and reprocessing procedures to maintain safety and performance.	Single Use

Device Description

Device Overview	Polyolefin/Fluoropolymer Suture, Multifilament (Polyethylene) is a sterile, synthetic, non-absorbable surgical suture intended for soft tissue approximation, ligation, and tissue support during surgical and minimally invasive procedures. The device consists of multiple polyethylene-based filaments braided or intertwined into a multifilament structure and may incorporate polyolefin and/or fluoropolymer surface treatments or coatings to improve handling performance, reduce tissue drag, enhance knot run-down characteristics, and increase abrasion resistance. Polyethylene is a long-chain polyolefin polymer recognized for its excellent biocompatibility, chemical inertness, minimal tissue reactivity, and long-term retention of tensile strength in physiological environments. The multifilament construction provides increased flexibility, pliability, knot security, and handling characteristics compared with equivalent monofilament configurations, facilitating precise tissue approximation and secure knot formation during surgical procedures. Depending on the design, fluoropolymer materials such as polytetrafluoroethylene (PTFE) or polyvinylidene fluoride (PVDF) may be incorporated as coatings or surface-modification layers to reduce friction during tissue passage and improve the overall performance of the braided structure. The suture is intended for use in general surgery, cardiovascular surgery, plastic and reconstructive surgery, gastrointestinal surgery, orthopedic soft-tissue repair, and other procedures requiring durable, long-term wound support. The device achieves wound closure by mechanically maintaining approximation of tissue edges until healing has occurred while minimizing adverse tissue response associated with implanted suture materials.
Principle of Operation	The multifilament polyethylene strands are braided to provide flexibility and handling characteristics. Polyolefin and/or fluoropolymer coatings may be applied to reduce friction during tissue passage and improve knot performance. Once implanted, the suture mechanically approximates tissues and maintains wound support while remaining substantially unchanged within the body.
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	The device incorporates a multifilament polyethylene (polyolefin) suture architecture combined with optional fluoropolymer-based surface modification technologies to enhance handling performance, reduce tissue drag, and facilitate secure knot formation. The braided filament structure provides improved flexibility and knot security compared with conventional monofilament polyethylene sutures, while the chemically inert polyethylene material offers long-term tensile strength retention and minimal tissue reactivity. Fluoropolymer surface engineering further improves lubricity and tissue passage characteristics, supporting atraumatic wound closure and durable tissue approximation in procedures requiring permanent mechanical support.
Components	Suture Filaments Surgical Needle (Optional) Fluoropolymer (e.g., PTFE, PVDF, FEP) and/or Polyolefin Coating Medical-Grade Polymer Films, Foil Laminates, Paper or Tyvek®
Accessories	Surgical needle (where not integral to the device), needle holder, surgical forceps, suture scissors, knot pusher, minimally invasive suturing instruments, and other standard surgical instruments used for suture placement, knot formation, and tissue approximation.
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 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	Polyethylene [Synthetic Polyolefin Polymer] Fluoropolymer (e.g., PTFE, PVDF, FEP) and/or Polyolefin Coating Austenitic Stainless Steel Medical-Grade Polymer Films, Foil Laminates, Paper or Tyvek®
Active Components	Not applicable.
Coatings	Siliconized surface treatment Fluoropolymer (e.g., PTFE, PVDF, FEP) and/or Polyolefin Coating
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.

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

Attribute i

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.

Specification

Primary Performance Function i

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.

Tissue approximation, ligation, compression, and structural fixation.

Tensile Strength i

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.

USP Size	Minimum Tensile Strength (N)
5-0	3.92 N
4-0	5.88 N
3-0	9.41 N
2-0	14.1 N
0	21.2 N
1	26.7 N
2	34.5 N

Conforms to USP/NF Nonabsorbable Surgical Suture tensile strength requirements for the declared USP size.

Mechanical Stability i

Mechanical stability reflects the ability of the device to maintain structural integrity and functional performance under physiological loading conditions throughout its intended implantation period.

Maintains structural integrity and fixation under physiological loads.

Fatigue Resistance i

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.

Test Parameter	Typical Measure
Cyclic Tensile Loading	Number of cycles to failure
Residual Tensile Strength	% strength retained after cyclic loading
Knot Fatigue Performance	Cycles to knot failure
Filament Abrasion Resistance	Surface degradation after repetitive motion
Flexural Fatigue Resistance	Resistance to repeated bending and deformation

Demonstrates resistance to degradation, fracture, unraveling, or loss of functional performance when exposed to repetitive mechanical loading and physiological movement under intended use conditions.

Corrosion Resistance i

Corrosion resistance is important for preserving material integrity and minimizing degradation, ion release, or loss of mechanical performance in the physiological environment.

High resistance to corrosion and material degradation in vivo.
Resistance to degradation by clinically relevant chemicals and biological fluids

Flexibility and Handling i

Flexibility influences surgical handling, placement, and adaptation to anatomical structures. Appropriate flexibility helps facilitate implantation while maintaining device integrity.

Designed to permit controlled manipulation and placement during surgical procedures.

Load-Bearing Capability i

Load-bearing capability evaluates the ability of the device to transfer and sustain tensile forces across tissues or anatomical structures without functional failure.

Minimum Load-Bearing Capability / Minimum Ultimate Load Before Failure

USP Size	Minimum Ultimate Load Before Failure (N)
5-0	3.92
4-0	5.88
3-0	9.41
2-0	14.1
0	21.2
1	26.7
2	34.5

Reference: USP/NF Nonabsorbable Surgical Suture requirements for Class I synthetic non-absorbable sutures.

Typical Performance Characteristics

Test Parameter	Typical Result
Tensile Strength Retention	>90–100% over long-term implantation (non-absorbable sutures)
Elongation at Break	10–35% (material and braid dependent)
Cyclic Load Resistance	No breakage during validated cyclic loading protocol
Knot Integrity Under Load	Failure should occur in suture material rather than knot slippage
Functional Load Performance	Maintains tissue approximation throughout intended healing period

Informative values representing typical engineering and clinical performance characteristics; actual performance may vary based on material composition, USP size, braid construction, coating technology, and manufacturer specifications.

Dimensional Stability i

Dimensional stability assesses the ability of the device to retain its physical dimensions and mechanical properties throughout storage and implantation.

Maintains dimensional and mechanical characteristics during long-term implantation.

Tissue Approximation Capability i

This reflects the effectiveness of the device in maintaining tissue apposition and preventing separation during the healing process.

Typical Tissue Approximation Performance Characteristics

Test Parameter	Typical Result
Tissue Edge Apposition	Maintains close alignment of wound or tissue edges
Wound Closure Integrity	Sustains closure without dehiscence under expected physiological loads
Knot Security	Maintains tissue approximation without knot slippage
Load Distribution	Provides uniform tension across approximated tissues
Tissue Holding Strength	Maintains fixation without pull-through or excessive tissue trauma
Approximation Retention	Preserves tissue alignment throughout the intended support period
Handling During Placement	Facilitates accurate tissue positioning and closure
Functional Wound Support	Supports tissue healing while maintaining anatomical alignment

Tissue approximation capability is typically demonstrated through tensile strength, knot security, simulated-use evaluations, tissue holding assessments, and clinical performance validation rather than a single pharmacopeial acceptance criterion.

Radiographic Visibility i

Visibility under radiographic imaging may assist clinicians in postoperative assessment, localization, and evaluation of fixation integrity.

Not Applicable – Standard polyethylene multifilament sutures are generally radiolucent and are not intended to provide radiographic visibility unless specifically manufactured with radiopaque components.

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, Knot Security, 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

ISO 14971 i International standard specifying the process for identifying, evaluating, controlling, and monitoring risks associated with medical devices throughout their lifecycle.
ISO 13485 i International quality management system standard for organizations involved in the design, manufacture, distribution, and servicing of medical devices.
IS 9165 i Surgical instruments — Needles, suture.
ISO 5832-1 i Wrought stainless steel
ISO 10993-1 i Provides the framework for biological evaluation of medical devices within a risk management process based on the nature and duration of patient contact.
ISO 10993-2 i Specifies animal welfare requirements and ethical considerations for biological evaluation studies involving animals.
ISO 10993-3 i Provides methods for assessing genotoxicity, carcinogenicity, and reproductive toxicity associated with medical device materials.
ISO 10993-4 i Provides guidance for evaluating interactions between medical devices and blood, including hemocompatibility testing.
ISO 10993-5 i Specifies methods for in vitro assessment of the cytotoxic potential of medical device materials.
ISO 10993-6 i Provides methods for evaluating local tissue effects and biological responses following implantation.
ISO 10993-7 i Specifies allowable limits and evaluation methods for ethylene oxide sterilization residuals on medical devices.
ISO 10993-9 i Provides a framework for identifying and quantifying degradation products generated from medical device materials.
ISO 10993-10 i Specifies methods for assessing skin sensitization and irritation potential of medical device materials.
ISO 10993-11 i Provides methods for evaluating acute, subacute, subchronic, and chronic systemic toxicity associated with medical devices.
ISO 10993-12 i Specifies requirements for sample preparation and reference materials used during biological evaluation testing.
ISO 10993-13 i Provides methods for identification and quantification of degradation products generated from polymeric medical device materials.
ISO 10993-15 i Provides methods for identification and quantification of degradation products released from metallic materials and alloys used in medical devices.
ISO 10993-16 i Provides principles and methods for toxicokinetic studies of degradation products and leachable substances.
ISO 10993-17 i Provides methods for establishing allowable limits for leachable substances and evaluating toxicological safety margins.
ISO 10993-18 i Provides requirements for chemical characterization of medical device materials and constituent substances.
ISO 10993-19 i Provides methods for physicochemical, morphological, and topographical characterization of medical device materials.
ISO 10993-20 i Provides principles and methods for immunotoxicology testing and evaluation of medical devices.
ISO 10993-22 i Provides guidance on biological evaluation considerations for medical devices incorporating nanomaterials.
ISO 10993-23 i Specifies methods for evaluating irritation potential associated with medical device materials and extracts.
ISO 11135 i Requirements for development, validation, and routine control of ethylene oxide sterilization processes for medical devices.
ISO 11137 i Requirements for validation and control of radiation sterilization processes for medical devices.
ISO 15223-1 i Specifies symbols used in medical device labeling to communicate safety and regulatory information.
ISO 20417 i Specifies information to be supplied by the manufacturer for safe identification and use of medical devices.
ASTM F138 / ASTM F139 i Material specifications for implant-grade stainless steel commonly used in metallic surgical sutures and implantable medical devices.
ASTM F67 / ASTM F136 i Material specifications for commercially pure titanium and titanium alloy used in implantable medical devices.
ISO 7153-1 i Specifies metallic materials suitable for surgical instruments and related medical applications.
ASTM F899 i Specifies requirements for wrought stainless steels commonly used in surgical instruments and surgical needle manufacture.
ASTM F1840 i Provides standardized terminology, nomenclature, and definitions for surgical suture needles, supporting consistent specification, design, testing, and communication throughout the medical device lifecycle.

USP <861>	Suture Diameter
USP <871>	Needle Attachment
USP <881>	Tensile Strength

Sustainability Profile

Environmental Impact i Assessment of the device's environmental footprint throughout manufacturing, distribution, use, and disposal.	Moderate – Lifecycle Dependent
Recyclable Content i Percentage of device materials that can be recovered, recycled, or reused through established recycling processes.	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.
Reusable Components i Components designed for repeated use after validated cleaning, maintenance, or refurbishment.	Recycling or reuse of used devices may be limited by biological contamination and healthcare-waste requirements.
Battery Sustainability i Assessment of battery longevity, replaceability, recycling options, and environmental considerations.	Not Applicable
Hazardous Substance Status i Presence or absence of restricted substances regulated under environmental legislation.	The device should be designed and manufactured to minimize patient, user, and environmental exposure to hazardous substances. The device shall not contain carcinogenic, mutagenic, or reproductive toxic (CMR) substances classified as Category 1A or 1B, or endocrine-disrupting substances identified in accordance with applicable regulatory requirements, at concentrations above 0.1% (w/w), unless a justified benefit-risk assessment and regulatory compliance documentation are provided.
Carbon Footprint Category i Estimated lifecycle greenhouse gas impact associated with manufacturing, transportation, operation, and disposal.	Medium or If Manufacturer have Lifecycle Assesemnt Specific data
Packaging Sustainability i Evaluation of recyclable, biodegradable, or reduced-waste packaging materials.	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)
End-of-Life Disposal i Recommended disposal pathway for device components after end of service life.	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
Circular Economy Potential i Potential for refurbishment, remanufacturing, reuse, material recovery, and waste reduction.	Low to Moderate — Material Recovery Dependent.
Sustainability Rating i Composite sustainability assessment based on environmental, material, lifecycle, and circular economy factors.	6 / 10 i 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.

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

7.2 / 10

High rating indicates high compliance burden involving software controls, clinical evidence, post-market surveillance, and extensive technical documentation.

Standards Coverage 99%

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.

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