PolyLock Midfoot MF-LK-2742
PolyLock Midfoot MF-LK-2742 is a Class II device made by Fusion Orthopedics, LLC, cleared under FDA 510(k) K211843 on 4 Mar 2022 and listed in FDA GUDID since 16 Dec 2025 (UDI-DI 00840124524941), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00840124524941 | Date16 Dec 2025 | StatusListed |
| United States | FDA 510(k)SESE | NumberK211843 | Date4 Mar 2022 | StatusActive |
Official records
- AccessGUDID record 00840124524941
- FDA 510(k) database K211843
Across registries
- FDA 510(k) K211843 decided 4 Mar 2022 Active
- FDA GUDID UDI-DI 00840124524941 listed 16 Dec 2025 Listed
Timeline
- Cleared FDA 510(k) K211843
- Listed FDA GUDID 00840124524941
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- PolyLock Midfoot
- Generic name
- Orthopaedic bone screw (non-sliding)
- Model / Ref / Catalog
- MF-LK-2742
- Primary DI / UDI-DI
- 00840124524941
- 510(k) Number
- FDA product code
- HWC
- GMDN term
- Orthopaedic bone screw (non-sliding)
- Device class
- Class II
- Regulation number
- 888.3040
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
Similar devices
Other devices filed under FDA product code HWC (Screw, Fixation, Bone).
- Arthrex® AR-18720P-47 by Arthrex, Inc.
- Cannulated Screw 110007741 by Biomet Orthopedics, Inc.
- NCB® 02.03154.038 by Zimmer, Inc.
- 4845-32-01 00-4845-032-01 by Zimmer, Inc.
- CLAW II ORTHOLOC 3DSi 40240230 by WRIGHT MEDICAL TECHNOLOGY, INC.
- ACUMED 3004-23016-S by ACUMED LLC
- ACUMED 3005-40030 by ACUMED LLC
- Omni Stable AF 148-40170 by Extremity Medical, LLC
- Inion FreedomScrew™ 1 OSA-2730 by Inion, Ltd.
- PARTIALLY THREADED PEG TP26000 by Biomet Orthopedics, Inc.