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PCA Acetabular Insert II

by Howmedica Corp.

510(k) K921384

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

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

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK921384 Date25 Jun 1992ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

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  • Withdrawn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
JDL
Device Class
Class III
Regulation
21 CFR Part 888.3320
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 PCA Acetabular Insert II is a Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component). This device is designed as a metal acetabular cup component intended for use in total hip arthroplasty, providing a semi-constrained interface between the femoral head and the acetabular shell to enhance stability and articulation.

The PCA Acetabular Insert II is supplied as a reusable medical device and is intended for use in orthopedic surgical settings. It is classified as a Class III device under FDA regulations and was granted FDA 510K clearance as substantially equivalent to a predicate device. Multiple registration numbers and FEI numbers are associated with its distribution, reflecting its regulatory compliance and manufacturing traceability.

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