Anatomic Locking Plating System
510(k) K082300
Anatomic Locking Plating System is a Class II device made by Depuy Orthopaedics, Inc., cleared under FDA 510(k) K082300 on 18 Feb 2009, active as of 22 Oct 2026. 2 FDA recalls are linked to it.
Active
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK082300 | Date18 Feb 2009 | StatusActive |
Official records
- FDA 510(k) database K082300
Recalls
-
- Terminated Z-0450-2016
These screws have a single lead (instead of a triple lead) thread. The screw may sit proud in the plate, If the screw does not lock into the plate; the screw may back out. If the screw sits proud, soft tissue irritation may occur. If the screw does not lock into the plate and backs out, a revision surgery may be necessary.
-
- Terminated Z-0716-2014
3.5mmx38mm Locking Cortical Screw, implants are being recalled since an investigation identified that a 3.5mmx28mm Cortical Locking Screw is labeled as a 3.5mmx38mm Cortical Locking Screw.
Timeline
- Cleared FDA 510(k) K082300
- Recall initiated FDA recalls Z-0716-2014
- Recall initiated FDA recalls Z-0450-2016
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- HRS
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3030
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent