# K254176: Sinefix

- Pathway: 510(k) (Special)
- Applicant: BAAT Medical Products B.V.
- Decided: Mar 16, 2026 after 83 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: 11 generations back to K904436 (1990). 77 ancestors in all.
No later device cites it as a predicate yet.
0 of 78 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220966: Sinefix, BAAT Medical Products B.V. (2023) Summary page 5.

## Indications for use
The SINEFIX is intended for fixation of soft tissue to bone. The SINEFIX is intended for the following indications: o Shoulder: Rotator Cuff Repairs, Deltoid Repair. o Foot/Ankle: Achilles Tendon Repair. o Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair. Patellar Tendon Repair, Quadriceps Tendon Rupture Repair. o Elbow: Biceps Tendon Reattachment. Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis Repair. o Hip: Gluteus Medius repair, Gluteus Minimus repair.

Source page: https://510kreport.com/device/K254176
Methodology: https://510kreport.com/methodology