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Pinnacle Complete Acetabular Hip System

by Depuy Orthopaedics, Inc.

PMA P090002510(k) K001534

Active United States

PMA, withdrawn 510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), FDA PMA, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMA PMA NumberP090002 Date13 Jun 2011ApprovedStatusWithdrawn
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Special NumberK001534 Date12 Jun 2000ClearedStatusActive

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.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k), FDA PMA Active

Specification

510(k) · PMA

Generic name
Prosthesis, hip, semi-constrained, ceramic-on-metal articulation
PMA number
510(k) Number
FDA product code
LPH
Device class
Class II
Regulation
21 CFR Part 888.3358
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Pinnacle Complete Acetabular Hip System is a semi-constrained, ceramic-on-metal articulation hip prosthesis. It is indicated for use in total hip arthroplasty as a primary joint replacement for skeletally mature patients suffering from moderate pain due to non-inflammatory degenerative joint disease, including osteoarthritis or post-traumatic arthritis.

This device is designed for uncemented fixation and is supplied as a single-use system. Pinnacle Ultamet inserts must be used exclusively with DePuy femoral and acetabular components that feature matching inner and outer diameters. The system has received both FDA 510(k) and PMA authorizations.

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Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the intended use of the Pinnacle Complete Acetabular Hip System?

    This system is intended as a primary joint replacement prosthesis for total hip arthroplasty in skeletally mature patients who experience at least moderate pain in the hip joint caused by non-inflammatory degenerative joint disease, such as osteoarthritis or post-traumatic arthritis.

  • Is the Pinnacle Complete Acetabular Hip System reusable?

    No, the Pinnacle Complete Acetabular Hip System is a single-use device and should not be reused after the initial procedure.

  • Can I use the Pinnacle Ultamet inserts with any hip component?

    No, the Pinnacle Ultamet inserts are specifically intended for use only with DePuy femoral and acetabular components that have matching inner and outer diameters.

  • How is the Pinnacle Complete Acetabular Hip System fixed in place?

    The system is designed for uncemented fixation, meaning it is intended to be secured without the use of bone cement.