Cleared Traditional

K121439 - METAFIX FEMORAL HIP STEM SIZE 1

K121439 is an FDA 510(k) clearance for METAFIX FEMORAL HIP STEM SIZE 1, 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 122-day FDA review.

K121439 · Corin USA · Orthopedic device
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Sep 2012
Decision
122d
Days
Class 2
Risk

K121439 is an FDA 510(k) clearance for the METAFIX FEMORAL HIP STEM SIZE 1. 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 September 14, 2012 after a review of 122 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 Corin USA devices

FDA 510(k) Submission Details - K121439

510(k) Number K121439 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 2012
Decision Date September 14, 2012
Days to Decision 122 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
At panel average
Panel avg: 122d · This submission: 122d
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 K121439.
VERSAFITCUP CC TRIO EXTENSION
K122911 · Medacta International · Oct 2012
MPACT EXTENSION
K122641 · Medacta International · Sep 2012
BENCOX FORET & BENCOX DELTA
K121665 · Corentec Co., Ltd. · Sep 2012
SL-PLUS MIA FEMORAL STEMS WITH TI/HA COATING
K122296 · Smith & Nephew, Inc. · Aug 2012
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