Cleared Traditional

K162942 - Corin MetaFix Hip Stem

K162942 is an FDA 510(k) clearance for Corin MetaFix Hip Stem, manufactured by Corin U.S.A. Limited. The device is a Class 2 Orthopedic device with product code LZO cleared through the Traditional 510(k) pathway after a 242-day FDA review.

K162942 · Corin U.S.A. Limited · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2017
Decision
242d
Days
Class 2
Risk

K162942 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 June 20, 2017 after a review of 242 days - an extended review 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: 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 U.S.A. Limited devices

FDA 510(k) Submission Details - K162942

510(k) Number K162942 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 2016
Decision Date June 20, 2017
Days to Decision 242 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
120d slower than avg
Panel avg: 122d · This submission: 242d
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 476
Devices cleared under the same product code (LZO) and FDA review panel - the closest regulatory comparables to K162942.
PROCOTYL® PRIME E-CLASS™ XLPE Liner
K171181 · Microport Orthopedics, Inc. · Aug 2017
Locking Cage, Full XPE Cup
K163441 · United Orthopedic Corporation · Aug 2017
MiniMAX
K170845 · Medacta International S.A. · Aug 2017
AMIStem-H Proximal Coating
K161635 · Medacta International S.A. · Mar 2017
LINK® SP-CL® Hip System PoroLink® (microporous) and HX® (CaP) coated & LINK® LCU® Hip System PoroLink® (microporous) and HX® (CaP) coated
K161840 · Waldemar Link GmbH & Co. KG · Mar 2017
Revision Femoral Stem
K161226 · Lima Corporate S.P.A. · Feb 2017