Written and maintained by CASRAI Editorial Board
Last updated
General product and regulatory information for laboratory, clinic and supply staff. This page is not medical advice and does not describe any surgical technique.
Short answer
FiberWire is Arthrex’s brand name for a non-absorbable orthopedic suture. Arthrex describes it as an ultra-high molecular weight polyethylene (UHMWPE) core with a braided polyester and UHMWPE jacket. FDA’s 2002 clearance record (K021434), however, describes a braided polyester family under product code GAT. A brand name is not a material, so records should cite both.
Definition and scope
“FiberWire” is a brand of Arthrex, Inc. It names a product line, not a generic suture material, in the way that “polyester suture” or “UHMWPE suture” names a material. This page explains what the name refers to, what the two primary sources (an Arthrex product page and an FDA clearance record) say about its construction and regulatory listing, and how procurement and records staff can read a FiberWire catalogue entry. It sits alongside the general guides on orthopedic sutures and what a suture is, which cover suture types and classes and are not repeated here.
How the product is described in practice
What the manufacturer says (Arthrex product page, checked 2026-11-01)
- Arthrex states that FiberWire suture is “constructed of a multi-strand, long chain ultra-high molecular weight polyethylene (UHMWPE) core with a braided jacket of polyester and UHMWPE”.
- Arthrex claims “superior strength, soft feel and abrasion resistance that is unequaled in orthopedic surgery” and says suture breakage during knot tying is “virtually eliminated”. These are manufacturer marketing statements; this page reports them and does not evaluate them.
- Arthrex states FiberWire is “the first suture on the market to offer a collagen coated option”, and notes that the collagen coated sutures are not available in Eastern and Southern Hemisphere countries.
What FDA’s record says (510(k) K021434)
The FDA premarket notification database lists “ARTHREX FIBERWIRE IN USP SIZES” under 510(k) K021434, applicant Arthrex, Inc., decision date 7 November 2002, decision “Substantially Equivalent”, traditional clearance. The product code is GAT and the regulation number is 21 CFR 878.5000. The openFDA classification name for GAT is “Suture, Nonabsorbable, Synthetic, Polyethylene”. The 510(k) summary, as reproduced by an FDA-data mirror (Innolitics, checked 2026-11-01), calls the device a non-absorbable, synthetic suture family of braided long-chain polyesters, available in various USP diameters, and states it is intended for approximation or ligation of soft tissues, including use of allograft tissue in orthopedic surgery.
Two sources, two descriptions
The table sets out who said what, and when. It does not decide which description is current for a given lot; that question belongs to the product’s own labeling.
| Item | FDA record K021434 (2002) | Arthrex product page (checked 2026-11-01) |
|---|---|---|
| Material wording | Braided long-chain polyesters; non-absorbable, synthetic | UHMWPE core with braided polyester and UHMWPE jacket |
| Intended use wording | Approximation or ligation of soft tissues, including allograft tissue in orthopedic surgery | Positioned for orthopedic surgery, including arthroscopic use |
| Regulatory identifiers | Product code GAT; 21 CFR 878.5000 | Not stated on the page |
| Coating | Not described in the 510(k) summary | Collagen coated option; not available in Eastern and Southern Hemisphere countries |
| Nature of source | Regulator’s clearance record | Manufacturer marketing |
Types and related names
Searchers meet FiberWire next to other brand names, including FiberWire suture, TigerWire, UltraTape, OrthoCord and UltraBraid. Each is a separate catalogue name, and a name’s resemblance to another does not establish that the two share a construction, maker, or clearance. The only construction statements this page makes are the Arthrex and FDA statements above, and they concern FiberWire. For any other name, read that product’s own labeling and its own 510(k) or classification entry.
Class context: suture of this kind is regulated under 21 CFR 878.5000, and the general-versus-absorbable distinction is covered in absorbable vs non-absorbable sutures. For a different non-absorbable synthetic, see PTFE suture.
Where it matters for labs, clinics and supply decisions
A checklist for reading a FiberWire catalogue or inventory line, built from the two sources above:
- Brand versus material. Record the brand (FiberWire) and, separately, the material statement from the current instructions for use. Do not substitute one for the other.
- USP size. The 510(k) title refers to USP sizes. Size is a field on the label and catalogue entry; take it from there, not from the brand name.
- FDA identifiers. Note the product code (GAT) and regulation number (21 CFR 878.5000) if your record system holds them, and note which 510(k) a document cites, since a manufacturer can hold several.
- Coating variant. Arthrex lists a collagen coated option and says it is not available in Eastern and Southern Hemisphere countries. A catalogue check by region is therefore part of confirming a coated variant, and the catalogue of your own region governs.
- Date of each statement. Keep the date of the source (for example, a 2002 clearance versus a 2026 product page) next to each material or claim.
Common misunderstandings
Is FiberWire a material?
No. It is a brand name. The material is described in labeling; here the manufacturer states UHMWPE and polyester components.
Does the FDA record confirm Arthrex’s strength claims?
No. The 510(k) records a substantial-equivalence decision and an intended use. The strength and abrasion statements come from Arthrex’s own page and are the manufacturer’s claims.
Why do the FDA and Arthrex descriptions differ?
They are different documents from different dates, with different purposes. Neither document says whether construction changed between them, so this page does not assert that it did or did not.
FAQ
What is FiberWire suture?
It is Arthrex’s brand of non-absorbable orthopedic suture. Arthrex describes a UHMWPE core with a polyester and UHMWPE braided jacket.
How does FDA list FiberWire?
Under 510(k) K021434 (decision 7 November 2002), product code GAT, 21 CFR 878.5000, for approximation or ligation of soft tissues.
Is FiberWire absorbable?
The FDA summary describes the family as non-absorbable and synthetic.
Sources
All sources checked 2026-11-01.
- Arthrex, Inc., FiberWire suture product page (manufacturer statements): https://www.arthrex.com/shoulder/sutures
- FDA 510(k) K021434, “Arthrex FiberWire in USP Sizes”, decision 2002-11-07, via openFDA: https://api.fda.gov/device/510k.json?search=k_number:K021434
- FDA-data mirror of the K021434 summary (Innolitics): https://fda.innolitics.com/device/K021434
- openFDA device classification, product code GAT, 21 CFR 878.5000: https://api.fda.gov/device/classification.json?search=product_code:GAT
