Skip to content

Medacta Total Hip Prothesis System-Amisten H, Quadra H, Quadra S

by Medacta International S.A.

510(k) K093944

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 26 Oct 2026. What this means

Regulatory status

as of registry sync 26 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK093944 Date21 Jan 2010ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0791-2013 FDA Class II initiated 17 Dec 2012 on shared 510(k) K093944

    The tip of the Quadra Trial Broach size 0, broke during a surgery.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

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  • Withdrawn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
LZO
Device Class
Class II
Regulation
21 CFR Part 888.3353
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Other devices from Medacta International S.A.

See all devices from Medacta International S.A. →