# Performance Fibers OEM LLC (contract manufacturer, Mansfield, MA): 58 new FDA device listings, incl. suture, nonabsorbable, synthetic, polyethylene

**Score:** 80/100

| Field | Value |
|---|---|
| Establishment | Performance Fibers OEM LLC |
| Role | Contract manufacturer |
| Establishment types | Manufacture Medical Device for Another Party (Contract Manufacturer) |
| Location | Mansfield, MA, US |
| New listings | 58 |
| Devices | Suture, Nonabsorbable, Synthetic, Polyethylene; Suture, Absorbable, Synthetic, Polyglycolic Acid; Suture, Surgical, Absorbable, Polydioxanone; Suture, Absorbable, Synthetic; Suture, Nonabsorbable, Synthetic, Polyamide; Suture, Nonabsorbable, Synthetic, Polypropylene; Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile; Suture, Absorbable, Natural; Suture, Nonabsorbable, Silk; Fastener, Fixation, Nondegradable, Soft Tissue |
| Product codes | GAT, GAM, NEW, GAN, GAR, GAW, GAQ, GAL, GAP, MBI, GAS, DXZ, GAO |
| Device classes | Class II |
| Medical specialties | General, Plastic Surgery, Orthopedic, Cardiovascular |
| Brand names | Force Fiber; Deknatel; ORTHODEK; POLYSORB SYNTHETIC ABSORBABLE SUTURE; ForceBraid; MULTIPLE POLYAMIDE SYNTH; BONDEK; Deknatel®, Deklene®, Deklene® Maxx™, Capio |
| First new listing | 2026-08-17 |
| Latest new listing | 2026-08-17 |
| FDA registration number | 1221601 |
| Registration expires | 2026-12-31 |

## Why this score
- Contract manufacturer or sterilizer adding work.
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.
- U.S. establishment.

Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm). Last refreshed: 2026-10-28T20:51:27.468Z.
From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.