# K132079: TFCC Fast-Fix Kit

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Dec 5, 2013 after 153 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: 4 generations back to K925573 (1993). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092508: Fast-Fix 360 Meniscal Repair System, Striaght, Curved, Reverse Curved,Fast Fix 360 AB Meniscal Repair System, Straight,, Smith & Nephew, Inc. (2010) Summary page 1.
- K072322: Ultra Fast-Fix and Ultra Fast-Fix AB Meniscal Repair Systems, Smith & Nephew, Inc. (2007) Summary page 1.

## Most influential descendants
- K262357: Arthrex Bioabsorbable PushLock Suture Anchors (2026), 0 descendants of its own

## Recalls of this device
- Apr 30, 2015 · Class II · Z-1822-2015: Sterility of device maybe compromised

## Indications for use
The Smith & Nephew TFCC FAST-FIX Kit is Intended for use as a suture retention device to facilitate Triangular Fibrocartilage Complex (TFCC) repair procedures.

Source page: https://510kreport.com/device/K132079
Methodology: https://510kreport.com/methodology