# K203855: CoNextions TR Tendon Repair System

- Pathway: 510(k) (Traditional)
- Applicant: Conextions Medical
- Decided: Apr 22, 2022 after 477 days
- Product code: GAQ (Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile)
- Device class: 2
- Regulation: 21 CFR 878.4495
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K931271 (1994). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023594: Teno Fix, Ortheon Medical, LLC (2003) Summary page 4.
- K946173: Stainless Steel, Gut, Poly (Glycolide/L-Lactide) Polyamide, Polypropylene, Poly (Ethylene Terephthalate) and Silk, ETHICON, Inc. (1995) Summary page 4.

## Indications for use
CoNextions TR Tendon Repair System is indicated for the repair of severed or lacerated Tendons in adults (22 years of age or older). The product is intended for the following indications: » Digital Flexor Tendons » Digital Extensor Tendons Proximal to the Metacarpophalangeal Joints (Zones 6-8)

Source page: https://510kreport.com/device/K203855
Methodology: https://510kreport.com/methodology