Cleared Traditional

K120362 - METAFIX FEMORAL STEM FOR HEMI-ARTHROPLASTY

K120362 is an FDA 510(k) clearance for METAFIX FEMORAL STEM FOR HEMI-ARTHROPLASTY, manufactured by Corin USA. The device is a Class 2 Orthopedic device with product code LZO cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K120362 · Corin USA · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2012
Decision
88d
Days
Class 2
Risk

K120362 is an FDA 510(k) clearance for the METAFIX FEMORAL STEM FOR HEMI-ARTHROPLASTY. Classified as Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (product code LZO), Class II - Special Controls.

Submitted by Corin USA (Tampa, US). The FDA issued a Cleared decision on May 4, 2012 after a review of 88 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Corin USA devices

FDA 510(k) Submission Details - K120362

510(k) Number K120362 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 2012
Decision Date May 04, 2012
Days to Decision 88 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
34d faster than avg
Panel avg: 122d · This submission: 88d
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 454
Devices cleared under the same product code (LZO) and FDA review panel - the closest regulatory comparables to K120362.
PROFEMUR Z REVISION HIP STEM
K121221 · Wrightmedicaltechnologyinc · Aug 2012
SL-PLUS STANDARD AND LATERAL FEMORAL STEM WITH TI/HA COATING
K120211 · Smith & Nephew, Inc. · Jul 2012
AMISTEM AND QUADRA - LINE EXTENSION
K121011 · Medacta International · Jun 2012
VERSAFITCUP CC TRIO-ADDITIONAL LINERS
K120531 · Medacta International · Apr 2012
METHA HIP SYSTEM
K112682 · Aesculap Implant Systems, LLC · Mar 2012
WAGNER CONE PROSTHESIS SYSTEM
K113556 · Zimmer GmbH · Feb 2012