Written and maintained by CASRAI Editorial Board
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This page describes products and general use; it is not medical advice.
PTFE suture is a nonabsorbable thread made from polytetrafluoroethylene, a fluoropolymer. In the United States, the regulated version is expanded PTFE (ePTFE), a monofilament that FDA classifies as Class II under 21 CFR 878.5035. This guide is for clinic staff, buyers and students who need to know what the product is, how it is classified, and how a bench-tested extruded PTFE monofilament differs from the regulated ePTFE device.
What is PTFE suture?
PTFE suture is a monofilament, nonabsorbable, sterile, flexible surgical thread. FDA’s regulation (21 CFR 878.5035, “Nonabsorbable expanded polytetrafluoroethylene surgical suture”) describes it as prepared from ePTFE and intended for soft tissue approximation and ligation, including cardiovascular surgery. It may be undyed or dyed with an approved color additive, and it may be supplied with or without an attached needle (eCFR, checked 2026-10-31).
Who uses it: surgeons and operating-room teams place it; supply and procurement staff, sterile processing and students meet it as a catalog item. For the wider category, see what a suture is and the absorbable versus non-absorbable suture comparison.
How it is built
One manufacturer, Gore Medical, describes its suture as a microporous, monofilament thread of flexible biomaterial made from ePTFE. Its needles are 300 series stainless steel alloy, tapered or piercing, and it states the surface is designed to give softer knots in subcutaneous tissue (Gore Medical product page, checked 2026-10-31). Because the thread is a single strand rather than a braid, it is a different construction from the products in the braided sutures category, which is one of several other suture types sold through lac.us.
FDA identity at a glance
| Item | What the source states | Source |
|---|---|---|
| Regulation | 21 CFR 878.5035, nonabsorbable expanded polytetrafluoroethylene surgical suture | eCFR, 2026-10-31 |
| Classification | Class II (special controls); the special control is FDA’s guidance document “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA” | eCFR, 2026-10-31 |
| Product code | NBY, “Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene”; class 2; specialty General, Plastic Surgery; implant flag Y | openFDA classification database, 2026-10-31 |
| Construction | Monofilament, sterile, flexible thread; with or without attached needle(s) | eCFR, 2026-10-31 |
| Intended use (regulation) | Soft tissue approximation and ligation, including cardiovascular surgery | eCFR, 2026-10-31 |
openFDA notes that its data are unvalidated and must not be used for care decisions; use it for identifying a product code, not for clinical judgment.
Types and variants
| Type | What is documented | Key difference | Source |
|---|---|---|---|
| ePTFE monofilament (product code NBY) | The material FDA’s regulation describes; Class II | Expanded, microporous structure; this is what 21 CFR 878.5035 covers | eCFR; Gore Medical, 2026-10-31 |
| Extruded PTFE monofilament | A USP 4/0 extruded monofilament PTFE thread (Seramon) was used in a 60-tendon cadaver study | Not ePTFE; the study’s findings should not be assumed to apply to ePTFE products | PMC8354926, 2026-10-31 |
| With attached needle | Permitted by the regulation; one manufacturer lists tapered or piercing needles | Needle shape and alloy are set by the product | eCFR; Gore Medical, 2026-10-31 |
| Without needle | Permitted by the regulation | Supplied as thread only | eCFR, 2026-10-31 |
| Undyed or dyed | Dyed versions use an approved color additive | Color only | eCFR, 2026-10-31 |
What one bench study shows
A cadaveric flexor tendon study (60 tendons, 10 repairs per group) compared suture materials. Its authors concluded that PTFE allowed easier approximation of the tendon stumps and that PTFE repair strength was equal to FiberWire’s. The PTFE in that study was a USP 4/0 extruded monofilament, not ePTFE, so treat it as one dated bench datum about a related material, not as a performance claim for ePTFE products (PMC8354926, checked 2026-10-31).
How to choose
These documented points apply when comparing products:
- Confirm the regulated identity. A device marketed as an ePTFE suture should match product code NBY and 21 CFR 878.5035 (Class II). Check the product code in the openFDA classification or AccessGUDID record.
- Read the contraindications in the instructions for use. Gore Medical’s product page lists the suture as contraindicated for ophthalmic surgery, microsurgery and peripheral neural tissue. Labeling can differ by product and market, so use the current IFU from the manufacturer (Gore publishes instructions at eifu.goremedical.com).
- Do not substitute a different PTFE thread on the strength of a study. Extruded and expanded PTFE are different materials.
Safe use and handling basics
The regulation describes the thread as sterile, and the manufacturer’s instructions for use govern handling, knotting and any restrictions. Choice of suture, technique and removal are decisions for the treating clinician; this page gives no procedural steps.
Common mistakes
- Treating “PTFE suture” as one product. The FDA-regulated ePTFE device and extruded PTFE monofilament are different materials.
- Applying the cadaver study’s results, which tested an extruded PTFE thread, to an ePTFE product.
- Relying on a manufacturer web page instead of the current IFU for contraindications.
- Reading an openFDA record as clinical guidance; the database states its data are unvalidated.
FAQ
What is PTFE suture?
PTFE suture is a nonabsorbable, sterile, monofilament surgical thread made from polytetrafluoroethylene. The FDA-regulated form is ePTFE (21 CFR 878.5035, Class II, product code NBY), intended for soft tissue approximation and ligation, including cardiovascular surgery.
Is PTFE suture absorbable?
No. FDA’s regulation defines it as nonabsorbable. For the category difference, see the absorbable versus non-absorbable comparison.
Where does PTFE appear in related suture guides?
The orthopedic sutures guide mentions a cardiovascular ePTFE product code, and the suture needle types guide and dental sutures guide cover needles and oral-use sutures.
Sources
- eCFR, 21 CFR 878.5035, Nonabsorbable expanded polytetrafluoroethylene surgical suture, https://www.ecfr.gov/current/title-21/part-878/section-878.5035 (checked 2026-10-31).
- openFDA device classification, product code NBY, https://api.fda.gov/device/classification.json?search=product_code:NBY (checked 2026-10-31).
- Gore Medical, Suture product page, https://goremedical.com/products/suture (checked 2026-10-31).
- Flexor tendon repair cadaver study, PubMed Central, https://pmc.ncbi.nlm.nih.gov/articles/PMC8354926/ (checked 2026-10-31).
