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Zimmer Periarticular Locking System

by Zimmer, Inc.

510(k) K141734

Zimmer Periarticular Locking System is a Class II device made by Zimmer, Inc., cleared under FDA 510(k) K141734 on 13 Aug 2014, active as of 22 Oct 2026. 3 FDA recalls are linked to it.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

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 NumberK141734 Date13 Aug 2014ClearedStatusActive

Official records

Recalls

3 recalls · 1 ongoing · FDA

    • Ongoing Z-2254-2023 FDA Class II initiated 27 Jun 2023

    Thread form issue of the locking holes in that the locking screws would not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the screw may not correctly lock.

  • 2 recalls, same reason

    • Terminated Z-0317-2020 FDA Class II initiated 10 Oct 2019
    • Terminated Z-0310-2020 FDA Class II initiated 10 Oct 2019

    Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

Timeline

4 dated events

  1. Cleared FDA 510(k) K141734
  2. Recall initiated FDA recalls Z-0317-2020
  3. Recall initiated FDA recalls Z-0310-2020
  4. Recall initiated FDA recalls Z-2254-2023

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  • Withdrawn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

cited in the FDA summary

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

Cites

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

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