# K253145: Pre-Sutured Tendon

- Pathway: 510(k) (Special)
- Applicant: Rti Surgical, Inc.
- Decided: Oct 22, 2025 after 27 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: 8 generations back to K990088 (1999). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K230036: Pre-Sutured Tendon (4561SC / Single Strand); Pre-Sutured Tendon (4564SC / Quadruple Strand ), Rti Surgical, Inc. (2023) Summary page 5.

## Indications for use
The Pre-Sutured Tendon is intended for use as a construct in anterior cruciate ligament and posterior cruciate ligament reconstruction. The Pre-Sutured Tendon is for single patient use only.

Source page: https://510kreport.com/device/K253145
Methodology: https://510kreport.com/methodology