510(k) K250989

Stryker and Serf hip devices by Howmedica Osteonics Corp (Dba Stryker Orthopaedics) — Product Code LPH

K250989 is an FDA 510(k) premarket notification submitted by Howmedica Osteonics Corp (Dba Stryker Orthopaedics) for the device "Stryker and Serf hip devices". The FDA issued a decision of Substantially Equivalent on July 25, 2025. The device falls under product code LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented), a Class II device regulated under 21 CFR 888.3358.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 25, 2025
Date Received
March 31, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Device Class
Class II
Regulation Number
888.3358
Review Panel
OR
Submission Type