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PCA Total Hip System (Cementless Use)

by Pfizer Hospital Products Group, Inc. 510(k)

Active United States

510(k) K920831

Overview

The PCA Total Hip System (Cementless Use) is an orthopedic device intended for total hip arthroplasty without the use of bone cement. It is designed for implantation in patients requiring hip joint replacement where bony ingrowth is expected to provide long-term fixation.

This device is supplied non-sterile and requires sterilization prior to use. It is intended for use in a hospital operating room setting by qualified orthopedic surgeons. The system includes femoral and acetabular components as specified in the 510(k) clearance K920831 under product code LPH, and is regulated as a Class II medical device by the FDA.

AI-generated from registry data, 25 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK920831 Date10 Jun 1992ClearedStatusActive

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

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

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Questions

  • What is the PCA Total Hip System (Cementless Use) intended for?

    The PCA Total Hip System (Cementless Use) is intended for total hip arthroplasty without bone cement, designed for implantation in patients requiring hip joint replacement where bony ingrowth is expected to provide long-term fixation.

  • How is the PCA Total Hip System supplied and prepared for use?

    The device is supplied non-sterile and requires sterilization prior to use by qualified orthopedic surgeons in a hospital operating room setting.

  • What components are included in the PCA Total Hip System?

    The system includes femoral and acetabular components as specified in the 510(k) clearance K920831 under product code LPH.