MPACT Acetabular System

by Medacta International

510(k) K103721

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

510(k) K103721↗

FDA record

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK103721	Date21 Mar 2011Cleared	StatusActive

Official records

FDA 510(k) database 510(k) number K103721

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K103721
FDA product code: LPH

Device class: Class II
Regulation: 21 CFR Part 888.3358
Advisory committee: Orthopedic
FDA decision: SESE Substantially Equivalent

Overview

AI-generated summary, 23 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 MPACT Acetabular System is an orthopedic device used in hip joint replacement procedures. It is designed to replace the acetabular component of the hip joint, providing a prosthetic socket for the femoral head.

The device is supplied as a reusable or single-use component depending on configuration, intended for use in surgical settings. It received FDA 510(k) clearance (K103721) as substantially equivalent to a predicate device, with product code LPH and review by the Orthopedic advisory committee. No claims regarding sterility, MRI safety, sizes, storage, or specific indications are made in the provided data.

Devices cleared under K103721

109 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K103721
		UDI-DI	Size and differences
CoCr Femoral Ball Head 01.25.086 Medacta International SA	01.25.086	07630030805349	—	On the market
CoCr Femoral Ball Head 01.25.087 Medacta International SA	01.25.087	07630030805356	—	On the market
CoCr Femoral Ball Head 01.25.088 Medacta International SA	01.25.088	07630030805363	—	On the market
CoCr Femoral Ball Head 01.25.089 Medacta International SA	01.25.089	07630030805370	—	On the market
Mpact Acetabular System 01.32.044SH Medacta International SA	01.32.044SH	07630030810138	—	On the market
Mpact Acetabular System 01.32.046DH Medacta International SA	01.32.046DH	07630030810145	—	On the market
Mpact Acetabular System 01.32.046SH Medacta International SA	01.32.046SH	07630030810176	—	On the market
Mpact Acetabular System 01.32.048DH Medacta International SA	01.32.048DH	07630030810183	—	On the market
Mpact Acetabular System 01.32.052SH Medacta International SA	01.32.052SH	07630030810299	—	On the market
Mpact Acetabular System 01.32.054SH Medacta International SA	01.32.054SH	07630030810343	—	On the market
Mpact Acetabular System 01.32.056SH Medacta International SA	01.32.056SH	07630030810398	—	On the market
Mpact Acetabular System 01.32.058DH Medacta International SA	01.32.058DH	07630030810404	—	On the market
Mpact Acetabular System 01.32.062DH Medacta International SA	01.32.062DH	07630030810503	—	On the market
Mpact Acetabular System 01.32.064DH Medacta International SA	01.32.064DH	07630030810558	—	On the market
Mpact Acetabular System 01.32.064SH Medacta International SA	01.32.064SH	07630030810596	—	On the market
Mpact Acetabular System 01.32.2237STT Medacta International SA	01.32.2237STT	07630030811227	—	On the market
Mpact Acetabular System 01.32.2239AT Medacta International SA	01.32.2239AT	07630030811234	—	On the market
Mpact Acetabular System 01.32.2239HCAT Medacta International SA	01.32.2239HCAT	07630030811241	—	On the market
Mpact Acetabular System 01.32.2241AT Medacta International SA	01.32.2241AT	07630030811272	—	On the market
Mpact Acetabular System 01.32.2241STT Medacta International SA	01.32.2241STT	07630030811302	—	On the market
Mpact Acetabular System 01.32.2244HCAT Medacta International SA	01.32.2244HCAT	07630030811326	—	On the market
Mpact Acetabular System 01.32.2248HCAT Medacta International SA	01.32.2248HCAT	07630030811364	—	On the market
Mpact Acetabular System 01.32.2248STT Medacta International SA	01.32.2248STT	07630030811388	—	On the market
Mpact Acetabular System 01.32.2252AT Medacta International SA	01.32.2252AT	07630030811395	—	On the market
Mpact Acetabular System 01.32.2252HCAT Medacta International SA	01.32.2252HCAT	07630030811401	—	On the market
Mpact Acetabular System 01.32.2252STT Medacta International SA	01.32.2252STT	07630030811425	—	On the market
Mpact Acetabular System 01.32.2837HCAT Medacta International SA	01.32.2837HCAT	07630030811524	—	On the market
Mpact Acetabular System 01.32.2837HCT Medacta International SA	01.32.2837HCT	07630030811531	—	On the market
Mpact Acetabular System 01.32.2837STT Medacta International SA	01.32.2837STT	07630030811548	—	On the market
Mpact Acetabular System 01.32.2841HCAT Medacta International SA	01.32.2841HCAT	07630030811609	—	On the market
Mpact Acetabular System 01.32.2841HCT Medacta International SA	01.32.2841HCT	07630030811616	—	On the market
Mpact Acetabular System 01.32.2841STT Medacta International SA	01.32.2841STT	07630030811623	—	On the market
Mpact Acetabular System 01.32.2844AT Medacta International SA	01.32.2844AT	07630030811630	—	On the market
Mpact Acetabular System 01.32.2844STT Medacta International SA	01.32.2844STT	07630030811661	—	On the market
Mpact Acetabular System 01.32.2848AT Medacta International SA	01.32.2848AT	07630030811678	—	On the market
Mpact Acetabular System 01.32.2848HCAT Medacta International SA	01.32.2848HCAT	07630030811685	—	On the market
Mpact Acetabular System 01.32.2852HCAT Medacta International SA	01.32.2852HCAT	07630030811722	—	On the market
Mpact Acetabular System 01.32.2852STT Medacta International SA	01.32.2852STT	07630030811746	—	On the market
Mpact Acetabular System 01.32.3239HCAT Medacta International SA	01.32.3239HCAT	07630030811838	—	On the market
Mpact Acetabular System 01.32.3244AT Medacta International SA	01.32.3244AT	07630030811890	—	On the market
Mpact Acetabular System 01.32.3244HCAT Medacta International SA	01.32.3244HCAT	07630030811906	—	On the market
Mpact Acetabular System 01.32.3248HCAT Medacta International SA	01.32.3248HCAT	07630030811944	—	On the market
Mpact Acetabular System 01.32.3248STT Medacta International SA	01.32.3248STT	07630030811968	—	On the market
Mpact Acetabular System 01.32.3252AT Medacta International SA	01.32.3252AT	07630030811975	—	On the market
Mpact Acetabular System 01.32.3252HCAT Medacta International SA	01.32.3252HCAT	07630030811982	—	On the market
Mpact Acetabular System 01.32.3644HCAT Medacta International SA	01.32.3644HCAT	07630030812101	—	On the market
Mpact Acetabular System 01.32.4048HCT Medacta International SA	01.32.4048HCT	07630030812262	—	On the market
Mpact Acetabular System 01.32.4052HCT Medacta International SA	01.32.4052HCT	07630030812286	—	On the market
Mpact Acetabular System 01.32.6525 Medacta International SA	01.32.6525	07630030812385	—	On the market
Mpact Acetabular System 01.32.6535 Medacta International SA	01.32.6535	07630030812408	—	On the market

Other devices from Medacta International

Versafitcup Cc Trio

Class II
Mectalif

Class II
Meta-C Cervical Plate

Class II
Gmk Sphere

Class II

See all devices from Medacta International →

Regulatory status

Coverage

Specification

Related clearances

Cites

Cited by

Overview

Devices cleared under K103721

Other devices from Medacta International

Versafitcup Cc Trio

Mectalif

Meta-C Cervical Plate

Gmk Sphere