# K170957: ReConnex Pre-Sutured Tendon

- Pathway: 510(k) (Traditional)
- Applicant: Allosource
- Decided: Mar 20, 2018 after 354 days
- Product code: GAT (Suture, Nonabsorbable, Synthetic, Polyethylene)
- Device class: 2
- Regulation: 21 CFR 878.5000
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K990088 (1999). 12 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041553: Arthrex Suture Grafting Kit, Arthrex, Inc. (2004) Summary page 4.

## Most influential descendants
- K181633: MTF Pre-Sutured Tendon (2019), 2 descendants of its own
- K230036: Pre-Sutured Tendon (4561SC / Single Strand); Pre-Sutured Tendon (4564SC / Quadruple Strand ) (2023), 1 descendant of its own
- K253145: Pre-Sutured Tendon (2025), 0 descendants of its own

## Indications for use
Pre-sutured allograft tendons are intended for use as a construct in anterior cruciate ligament and posterior cruciate ligament reconstruction.

Source page: https://510kreport.com/device/K170957
Methodology: https://510kreport.com/methodology