| K-number | K254176 |
| Device name | SINEFIX |
| Applicant | BAAT Medical Products B.V. |
| Product code | MBI |
| Device class | Class II |
| Decision date | Mar 16, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 888.3040 |
The SINEFIX is a PEEK implant designed to fixate soft tissue to bone, enabling reattachment of complete or partially ruptured soft tissue to facilitate healing. It consists of a baseplate with lateral and medial anchors and is indicated for various repairs including rotator cuff, Achilles tendon, knee ligament, elbow tendon, and hip muscle repairs.
The subject device has identical material (PEEK), dimensions (baseplate 10mm × 8mm, medial anchor Ø3mm × 16.24mm, lateral anchor Ø4.02 × 18.21mm), and design to the predicate SINEFIX K220966. Minor technological differences exist but do not adversely affect intended use or performance.
ASTM F3960-24 (mechanical performance evaluation) was used for verification and validation testing to confirm the device meets design specifications.
The modified SINEFIX is substantially equivalent to the predicate SINEFIX K220966 because both share identical material, dimensions, and intended use across multiple soft tissue-to-bone repair indications. Verification and validation testing, including ASTM F3960-24 mechanical performance evaluation, demonstrated equivalent performance to the predicate, and minor differences do not raise new safety or effectiveness concerns.
View the full FDA submission: accessdata.fda.gov