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Pinnacle 1218-28-448

by Depuy Orthopaedics, Inc.

Pinnacle 1218-28-448 (121828448) is a Class II device made by Depuy Orthopaedics, Inc., cleared under FDA 510(k) K001534 on 12 Jun 2000 (1 earlier submission) and listed in FDA GUDID since 24 Sep 2015 (UDI-DI 10603295011408), active as of 23 Oct 2026. One FDA recall is linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10603295011408 UDI-DI Date24 Sep 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) from GUDID NumberK001534 Date12 Jun 2000IssuedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K001534 decided 12 Jun 2000 Active· +1 more in the status table
  • FDA GUDID UDI-DI 10603295011408 listed 24 Sep 2015 Listed

Recalls

1 recall · FDA

    • Terminated Z-0569-2013 FDA Class II initiated 28 Nov 2012

    DePuy Orthopaedics, Inc. is issuing a voluntary recall of ten lots of the Pinnacle Cancellous Screw due to an incorrect description on the label. The label description reads Pinnacle Cannulated Screw and should read Pinnacle Cancellous Screw.

Timeline

4 dated events

  1. Cleared FDA 510(k) K000306
  2. Cleared FDA 510(k) K001534
  3. Recall initiated FDA recalls Z-0569-2013
  4. Listed FDA GUDID 10603295011408

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Pinnacle
Generic name
Non-constrained polyethylene acetabular liner
Model / Ref / Catalog
1218-28-448, 121828448
Primary DI / UDI-DI
10603295011408
510(k) Number
FDA product code
LPH
GMDN term
Non-constrained polyethylene acetabular liner
Device class
Class II
Regulation number
888.3358
GUDID distribution status
In Commercial Distribution

Related devices

Category: Non-constrained polyethylene acetabular liner

Cleared under the same submission (K000306)

and 8 more cleared under K000306

Cleared under the same submission (K001534)

and 8 more cleared under K001534

Other devices from Depuy Orthopaedics, Inc.

See all devices from Depuy Orthopaedics, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (9, all answered No)