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This page describes products and general use; it is not medical advice.
Orthopedic sutures are the strong, usually braided nonabsorbable threads and tapes used to hold soft tissue, tendon or bone-anchored repairs together. This guide is for clinic staff, buyers and students who need to know what the category means, how the FDA actually classifies orthopedic, ophthalmic and cardiovascular sutures, and what one open-access study found when it compared suture tape with round suture.
What orthopedic sutures are
An orthopedic suture is a surgical thread chosen for musculoskeletal work, such as tendon repair or soft tissue attached to bone with an anchor. The FDA does not define “orthopedic suture” as its own device type. In the FDA product code database (checked 2026-10-30) there is no product code with that name; sutures used in orthopedic work fall under the general suture codes, and suture anchors sit under the orthopedic panel as bone fixation devices (code NOV, 21 CFR 888.3030). For the basics of suture structure and sizing, see what a suture is; for needles, see suture needle types.
Who uses them: orthopedic and sports medicine surgical teams, with materials managers and sterile processing staff handling the supplies.
How they are built
FDA regulation 21 CFR 878.5000 describes a nonabsorbable polyester (PET) surgical suture as a multifilament, nonabsorbable, sterile, flexible thread indicated for soft tissue approximation, and states that it meets the U.S.P. requirements in the monograph for nonabsorbable surgical sutures (checked 2026-10-30). Polyester is one of several nonabsorbable materials; the same product code family also lists polypropylene (21 CFR 878.5010) and steel (21 CFR 878.4495) sutures. The difference between absorbable and nonabsorbable material is covered in absorbable vs non-absorbable sutures, and the kit side is in what a wound closure kit contains.
Specialty sutures: orthopedic, ophthalmic and cardiovascular
The table below lists the FDA product codes behind these families, taken from the openFDA device classification database (last updated 2026-10-19, checked 2026-10-30). The database carries an FDA disclaimer that it is unvalidated, so treat it as a reference to the FDA’s published product codes, not as a substitute for the regulation text.
| Family | Product code and name | Regulation | Class |
|---|---|---|---|
| Ophthalmic | HMN, Suture, Nonabsorbable, Ophthalmic | None listed | 3 |
| Ophthalmic | HMO, Suture, Absorbable, Ophthalmic | None listed | 3 |
| Cardiovascular | DTH, Suture, Cardiovascular | None listed | 3 |
| Cardiovascular | PAW, Nonabsorbable ePTFE surgical suture for chordae tendinae repair or replacement | 21 CFR 870.3470 | 2 |
| General nonabsorbable (used in orthopedic work) | GAS, Suture, nonabsorbable, synthetic, polyester | 21 CFR 878.5000 | 2 |
| General nonabsorbable (used in orthopedic work) | GAW, Suture, nonabsorbable, synthetic, polypropylene | 21 CFR 878.5010 | 2 |
| General nonabsorbable (used in orthopedic work) | GAQ, Suture, nonabsorbable, steel | 21 CFR 878.4495 | 2 |
| Orthopedic (anchor) | NOV, Anchor, suture, bone fixation, metallic | 21 CFR 888.3030 | 2 |
Ophthalmic sutures
Ophthalmic sutures have their own FDA product codes, one for absorbable (HMO) and one for nonabsorbable (HMN). Both are listed as Class 3 with no regulation number.
Cardiovascular sutures
The general cardiovascular suture code (DTH) is Class 3 with no regulation number. A separate code, PAW, covers an ePTFE suture for chordae tendinae repair or replacement and is Class 2. Related, 21 CFR 870.3470 describes polypropylene, PET or PTFE patches and pledgets as fabric devices placed in the heart to repair septal defects, for patch grafting, to repair tissue and to buttress sutures.
How the FDA classifies them
Are ophthalmic sutures Class 3? According to the openFDA classification database, yes: both ophthalmic suture product codes (HMN and HMO) and the cardiovascular suture code (DTH) are listed as Class 3. The common nonabsorbable synthetic and steel sutures in the table are Class 2. For polyester, 21 CFR 878.5000 names the FDA guidance “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA” as the special control.
Suture tape versus suture: one in vitro study
Borbas et al. (Arthroscopy, Sports Medicine, and Rehabilitation 2021;3(3):e873-e880, doi 10.1016/j.asmr.2021.01.029, open access, checked 2026-10-30) tested nine high-strength products used in rotator cuff repair: six tapes and three round sutures. The tests were in vitro and on human cadaveric tendon. Pooled results for tapes versus sutures:
| Measure | Tapes | Sutures |
|---|---|---|
| Load for 3 mm displacement | 201 N | 84 N |
| Displacement at 200 N | 3.6 mm | 6.6 mm |
| Stiffness | 46 N/mm | 25 N/mm |
| Ultimate load | 509 N | 288 N |
The authors reported all four differences as statistically significant (P<.0001). The authors noted that differences in the tendon tests appeared less substantial than in the dry laboratory tests. This is a single bench and cadaver study, not evidence of clinical outcomes, and it does not rank individual products.
Safe use and handling basics
- Follow the manufacturer’s instructions for use for the specific product, including sterility, storage and single-use statements.
- Regulation 21 CFR 878.5000 describes polyester sutures as sterile, so sterility and package integrity are labeling matters to check against the manufacturer’s instructions.
- Selection and use in a patient are clinical decisions for the surgical team and are outside the scope of this page.
Common mistakes
- Searching the FDA database for an “orthopedic suture” code: none exists, so the general suture codes apply.
- Assuming all specialty sutures share one class: the table shows Class 2 and Class 3 products.
- Treating bench-test numbers as clinical results.
FAQ
Are ophthalmic sutures Class 3?
Yes, in the openFDA classification database both ophthalmic suture product codes, HMN and HMO, are listed as Class 3 (checked 2026-10-30).
Is there an FDA product code for orthopedic sutures?
No code with that name appears in the database; general suture codes and orthopedic suture anchor codes (NOV) are used instead.
Are cardiovascular sutures Class 2 or Class 3?
The general cardiovascular suture code DTH is Class 3; the ePTFE chordae tendinae suture code PAW is Class 2.
Sources
All sources checked 2026-10-30.
- openFDA device classification API: https://api.fda.gov/device/classification.json?search=device_name:suture
- 21 CFR 878.5000: https://www.law.cornell.edu/cfr/text/21/878.5000
- 21 CFR 870.3470: https://www.law.cornell.edu/cfr/text/21/870.3470
- Borbas P et al., Arthroscopy, Sports Medicine, and Rehabilitation 2021;3(3):e873-e880: https://pmc.ncbi.nlm.nih.gov/articles/PMC8220614/ (doi 10.1016/j.asmr.2021.01.029)
