Cleared Traditional

22.2mm BIOLOX? delta Ceramic V40? Femoral Heads

K234025 · Howmedica Osteonics Corp., Dba Stryker Orthopaedics · Orthopedic

Apr 2024

Decision

126d

Days

Class 2

Risk

About This 510(k) Submission

K234025 is an FDA 510(k) clearance for the 22.2mm BIOLOX? delta Ceramic V40? Femoral Heads, a Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (Class II — Special Controls, product code LZO), submitted by Howmedica Osteonics Corp., Dba Stryker Orthopaedics (Malwah, US). The FDA issued a Cleared decision on April 24, 2024, 126 days after receiving the submission on December 20, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3353.

Submission Details

510(k) Number	K234025 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 20, 2023
Decision Date	April 24, 2024
Days to Decision	126 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	LZO — Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3353