Cleared Traditional

K250989 - Stryker and Serf hip devices
(FDA 510(k) Clearance)

K250989 · Howmedica Osteonics Corp., Dba Stryker Orthopaedics · Orthopedic

Jul 2025

Decision

116d

Days

Class 2

Risk

K250989 is an FDA 510(k) clearance for the Stryker and Serf hip devices, a Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (Class II — Special Controls, product code LPH), submitted by Howmedica Osteonics Corp., Dba Stryker Orthopaedics (Malwah, US). The FDA issued a Cleared decision on July 25, 2025, 116 days after receiving the submission on March 31, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3358.

Submission Details

510(k) Number	K250989 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 31, 2025
Decision Date	July 25, 2025
Days to Decision	116 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	LPH — Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3358