# K220966: Sinefix

- Pathway: 510(k) (Traditional)
- Applicant: BAAT Medical Products B.V.
- Decided: Mar 8, 2023 after 341 days
- Product code: MBI (Fastener, Fixation, Nondegradable, Soft Tissue)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K904436 (1990). 76 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 78 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200028: Coronet Soft Tissue Fixation System, Conextions Medical (2020) Summary page 4.

## Most influential descendants
- K254176: Sinefix (2026), 0 descendants of its own

## Indications for use
The PEEK SINEFIX is intended for soft tissue to bone reattachment in rotator cuff repairs for tendon ruptures up to 2 cm.

Source page: https://510kreport.com/device/K220966
Methodology: https://510kreport.com/methodology