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Modulus Compatible Stability (MCS)-HA Total Hip System

by Exactech, Inc.

510(k) K990197

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 NumberK990197 Date4 Feb 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  • Withdrawn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
MEH
Device class
Class II
Regulation
21 CFR Part 888.3353
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 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 Modulus Compatible Stability (MCS)-HA Total Hip System is a prosthetic hip replacement device classified as a porous-coated total hip arthroplasty. It features a metallic substrate made of either Ti-6Al-4V or Co-Cr-Mo alloy, coated with hydroxyapatite (HA) to enhance osseointegration and stability.

This device is intended for use in total hip arthroplasty procedures and is supplied as a reusable surgical implant. Cleared under FDA 510(k) clearance (K990197) via the Special 510(k) pathway, it adheres to orthopedic product code MEH. No additional regulatory or sterility details are specified in the provided data.

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