Cleared Traditional

Corin Metafix Hip Stem (K153381) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K153381 · Corin U.S.A. Limited · Orthopedic device
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Jan 2016
Decision
59d
Days
Class 2
Risk

K153381 is an FDA 510(k) clearance for the Corin Metafix Hip Stem. Classified as Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (product code LZO), Class II - Special Controls.

Submitted by Corin U.S.A. Limited (Tampa, US). The FDA issued a Cleared decision on January 21, 2016 after a review of 59 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 U.S.A. Limited devices

Submission Details

510(k) Number K153381 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 2015
Decision Date January 21, 2016
Days to Decision 59 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 122d · This submission: 59d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 287
Devices cleared under the same product code (LZO) and FDA review panel - the closest regulatory comparables to K153381.
MiniMAX
K170845 · Medacta International S.A. · Aug 2017
AMIStem-H Proximal Coating
K161635 · Medacta International S.A. · Mar 2017
Zimmer M/L Taper Hip Prosthesis
K161830 · Zimmer, Inc. · Oct 2016
REDAPT¿ Revision Femoral System
K151902 · Smith & Nephew, Inc. · Sep 2015
Exactech Alteon Monobloc Revision Stem
K150066 · Exactech, Inc. · Jul 2015
POLARSTEM Collared (Standard and Lateral) and Valgus Femoral Stem with Ti/HA
K143739 · Smith & Nephew, Inc. · Apr 2015