Cleared Traditional

K152903 - REVIVAL(TM) Modular Revision Hip Stem

K152903 is an FDA 510(k) clearance for REVIVAL(TM) Modular Revision Hip Stem, 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 211-day FDA review.

K152903 · Corin USA · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2016
Decision
211d
Days
Class 2
Risk

K152903 is an FDA 510(k) clearance for the REVIVAL(TM) Modular Revision 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 USA (Tampa, US). The FDA issued a Cleared decision on April 29, 2016 after a review of 211 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 USA devices

FDA 510(k) Submission Details - K152903

510(k) Number K152903 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 2015
Decision Date April 29, 2016
Days to Decision 211 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
89d slower than avg
Panel avg: 122d · This submission: 211d
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 453
Devices cleared under the same product code (LZO) and FDA review panel - the closest regulatory comparables to K152903.
Wagner SL Revision Stem Lateral, Wagner Cone Prosthesis® System
K161192 · Zimmer GmbH · Jul 2016
Corin Optimized Positioning System (OPS)
K152893 · Corin USA · Jun 2016
MasterLoc Stem
K160289 · Medacta International · May 2016
UCP Stem
K152530 · United Orthopedic Corporation · Mar 2016
Revision Femoral Stem
K151739 · Lima Corporate S.P.A. · Nov 2015
MasterLoc Stem
K151531 · Medacta International · Oct 2015