Cleared Traditional

28mm/38D MDM X3 Insert for MDM Liner

K233724 · Howmedica Osteonics Corp., Dba Stryker Orthopaedics · Orthopedic

Mar 2024

Decision

111d

Days

Class 2

Risk

About This 510(k) Submission

K233724 is an FDA 510(k) clearance for the 28mm/38D MDM X3 Insert for MDM Liner, 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 March 11, 2024, 111 days after receiving the submission on November 21, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3353.

Submission Details

510(k) Number	K233724 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 21, 2023
Decision Date	March 11, 2024
Days to Decision	111 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