# K203393: Fast-Fix Flex

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Feb 1, 2021 after 75 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: 4 generations back to K050021 (2005). 11 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121861: Smith & Nephew Ultra Fast-Fix Meniscal Repair System, Smith & Nephew Ultra Fast-Fix AB Meniscal Repair System, Smith & N, Smith & Nephew, Inc. (2012) Summary page 4.

## Most influential descendants
- K254188: Meniscus Versaflex (2026), 0 descendants of its own

## Indications for use
The FAST-FIX FLEX Meniscal Repair System is indicated for use in meniscal repairs, allograft transplant procedures, and anchoring the allograft to the meniscal rim during allograft transplant procedures.

Source page: https://510kreport.com/device/K203393
Methodology: https://510kreport.com/methodology