Skip to content

Mpact Acetabular System 01.32.2248STT

by Medacta International SA

Mpact Acetabular System 01.32.2248STT is a Class II device made by Medacta International SA, cleared under FDA 510(k) K103721 on 21 Mar 2011 and listed in FDA GUDID since 18 Nov 2014 (UDI-DI 07630030811388), active as of 12 Nov 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 12 Nov 2026

Documents

510(k) K103721

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number07630030811388 UDI-DI Date18 Nov 2014ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK103721 Date21 Mar 2011DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K103721 decided 21 Mar 2011 Active
  • FDA GUDID UDI-DI 07630030811388 listed 18 Nov 2014 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K103721
  2. Listed FDA GUDID 07630030811388

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Mpact Acetabular System
Generic name
Non-constrained polyethylene acetabular liner
Model / reference
01.32.2248STT
Description
Flat PE liner Ø 22 / F
Primary DI / UDI-DI
07630030811388
510(k) Number
FDA product code
LZO, LPH
GMDN term
Non-constrained polyethylene acetabular liner
Device class
Class II
Regulation number
888.3353, 888.3358
GUDID distribution status
In Commercial Distribution

Related devices

Category: Non-constrained polyethylene acetabular liner

Cleared under the same submission (K103721)

and 8 more cleared under K103721

Similar devices in this category

Other devices filed under Non-constrained polyethylene acetabular liner.

Other devices from Medacta International SA

See all devices from Medacta International SA →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (9, all answered No)