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Pca Acetabular Insert II, Additional Sizes, Styles

by Howmedica Corp.

510(k) K934440

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 NumberK934440 Date22 Feb 1994ClearedStatusActive

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  • Withdrawn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 semi-constrained metal cemented acetabular component for hip prostheses. Designed as a replacement for the natural acetabulum, it provides structural support and articulation for hip joint function, ensuring stability and durability in total hip arthroplasty procedures.

This device is supplied as a reusable orthopedic implant, intended for surgical use in controlled clinical settings. It is classified as a Class III medical device under FDA regulations and requires FDA 510(k) clearance. Multiple sizes and styles are available to accommodate varying patient anatomies, with regulatory filings referencing specific FEI numbers and registration details for traceability.

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