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APR Metasul Acetabular Insert

by Sulzermedica

510(k) K993569

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 · Special NumberK993569 Date1 Dec 1999ClearedStatusActive

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  • Withdrawn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 APR Metasul Acetabular Insert is a semi-constrained, metal, uncemented acetabular component for total hip arthroplasty. Classified as a Prosthesis, Hip (Semi-Constrained Metal Uncemented Acetabular Component), it is designed to replace the damaged acetabulum in hip joint replacement procedures.

This device is intended for use with APR Acetabular Shells and Metasul femoral heads. It is supplied in multiple sizes and configurations, as indicated by the listed FEI numbers, and is regulated under FDA 510(k) clearance (K993569) under the classification of Class III. The device is not described as single-use or reusable in the provided data, nor is MRI safety or sterility explicitly stated.

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