Cleared Traditional

K234025 - 22.2mm BIOLOX® delta Ceramic V40™ Femoral Heads

K234025 is an FDA 510(k) clearance for 22.2mm BIOLOX delta Ceramic V40 Femoral..., manufactured by Howmedica Osteonics Corp., Dba Stryker Orthopaedics. The device is a Class 2 Orthopedic device with product code LZO cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K234025 · Howmedica Osteonics Corp., Dba Stryker Orthopaedics · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2024
Decision
126d
Days
Class 2
Risk

K234025 is an FDA 510(k) clearance for the 22.2mm BIOLOX® delta Ceramic V40™ Femoral Heads. Classified as Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (product code LZO), Class II - Special Controls.

Submitted by Howmedica Osteonics Corp., Dba Stryker Orthopaedics (Mahwah, US). The FDA issued a Cleared decision on April 24, 2024 after a review of 126 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3353 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Howmedica Osteonics Corp., Dba Stryker Orthopaedics devices

FDA 510(k) Submission Details - K234025

510(k) Number K234025 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
4d slower than avg
Panel avg: 122d · This submission: 126d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LZO Device Classification - Class 2, Special Controls

Product Code LZO Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3353
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - LZO Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented

All 506
Devices cleared under the same product code (LZO) and FDA review panel - the closest regulatory comparables to K234025.
Z1 Cemented Hip System
K241241 · Orchard Medical Development, LLC · Aug 2024
CATALYSTEM Femoral Stems
K240381 · Smith & Nephew, Inc. · Jun 2024
EcoFit® short stem cementless cpTi
K240834 · Implantcast GmbH · Jun 2024
Ceramic Femoral Head
K240452 · Microport Orthopedics, Inc. · Apr 2024
28mm/38D MDM X3 Insert for MDM Liner
K233724 · Howmedica Osteonics Corp., Dba Stryker Orthopaedics · Mar 2024
Z1 Hip System
K233476 · Orchard Medical Development · Feb 2024