# K181633: MTF Pre-Sutured Tendon

- Pathway: 510(k) (Traditional)
- Applicant: Musculoskeletal Transplant Foundation
- Decided: Mar 15, 2019 after 268 days
- Product code: GAT (Suture, Nonabsorbable, Synthetic, Polyethylene)
- Device class: 2
- Regulation: 21 CFR 878.5000
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K990088 (1999). 13 ancestors in all.
2 later devices descend from it; 1 cites 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)
- K170957: ReConnex Pre-Sutured Tendon, Allosource (2018) Summary page 4.
- K041553: Arthrex Suture Grafting Kit, Arthrex, Inc. (2004) Summary page 4.

## Most influential descendants
- 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

## Recalls of this device
- Aug 15, 2019 · Class II · Z-2548-2019: Measurement listed on the label is not taken under tension, and this would cause possible extension of surgical time needed to complete the procedure.

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

Source page: https://510kreport.com/device/K181633
Methodology: https://510kreport.com/methodology