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Schuster Acetabular Cup for Cement/Cementless Fix

by Protek, Inc.

510(k) K870923

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 NumberK870923 Date14 Sep 1987ClearedStatusActive

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  • Withdrawn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
KWA
Device Class
Class III
Regulation
21 CFR Part 888.3330
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 Schuster Acetabular Cup is a semi-constrained metal acetabular component designed for hip replacement surgery. It serves as the socket portion of a total hip prosthesis, providing a stable interface for the femoral head to articulate within, whether fixed with bone cement or cementless techniques.

This device is intended for use in orthopedic settings during total hip arthroplasty procedures. Supplied sterile and intended for single-use, it is classified as a Class III medical device under FDA regulations. Multiple model variants are listed, each corresponding to specific acetabular cup sizes and configurations, and it requires proper surgical implantation by trained professionals. The device holds an FDA 510(k) clearance (K870923) for substantial equivalence.

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