Skip to content

Hipstar Femoral Stem

by Stryker Orthopaedics

510(k) K051223

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK051223 Date10 May 2006ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0227-2009 FDA Unclassified (pre-2012) initiated 20 Aug 2008

    The warning label "do not use with heads more than +10, offset" does not appear on 135 degree stem boxes. This warning is contained in the instructions for use.

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  • Withdrawn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 Stryker Orthopaedics

See all devices from Stryker Orthopaedics →