Skip to content

Locking Anatomic & Composite Plating System

by Depuy Orthopaedics, Inc.

510(k) K083843

Locking Anatomic & Composite Plating System is a Class II device made by Depuy Orthopaedics, Inc., cleared under FDA 510(k) K083843 on 20 Mar 2009, active as of 22 Oct 2026. 2 FDA recalls are linked to it.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK083843 Date20 Mar 2009ClearedStatusActive

Official records

Recalls

2 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-2308-2020 FDA Class II initiated 14 May 2020
    • Terminated Z-2310-2020 FDA Class II initiated 14 May 2020

    Distributed to the field without having completed design history files or design transfer activities

Timeline

3 dated events

  1. Cleared FDA 510(k) K083843
  2. Recall initiated FDA recalls Z-2308-2020
  3. Recall initiated FDA recalls Z-2310-2020

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

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

Related clearances

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Other devices from Depuy Orthopaedics, Inc.

See all devices from Depuy Orthopaedics, Inc. →