Cleared Traditional

K152893 - Corin Optimized Positioning System (OPS)

K152893 is an FDA 510(k) clearance for Corin Optimized Positioning System (OPS), 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 247-day FDA review.

K152893 · Corin USA · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2016
Decision
247d
Days
Class 2
Risk

K152893 is an FDA 510(k) clearance for the Corin Optimized Positioning System (OPS). 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 June 3, 2016 after a review of 247 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 - K152893

510(k) Number K152893 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2015
Decision Date June 03, 2016
Days to Decision 247 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
125d slower than avg
Panel avg: 122d · This submission: 247d
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 K152893.
Revision Femoral Stem
K161226 · Lima Corporate S.P.A. · Feb 2017
Zimmer M/L Taper Hip Prosthesis
K161830 · Zimmer, Inc. · Oct 2016
Wagner SL Revision Stem Lateral, Wagner Cone Prosthesis® System
K161192 · Zimmer GmbH · Jul 2016
MasterLoc Stem
K160289 · Medacta International · May 2016
REVIVAL(TM) Modular Revision Hip Stem
K152903 · Corin USA · Apr 2016
UCP Stem
K152530 · United Orthopedic Corporation · Mar 2016