Cleared Traditional

Corin Optimized Positioning System (OPS) Femoral (K193545) - FDA 510(k) Clearance

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

K193545 · Corin USA · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2020
Decision
228d
Days
Class 2
Risk

K193545 is an FDA 510(k) clearance for the Corin Optimized Positioning System (OPS) Femoral. 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 August 4, 2020 after a review of 228 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

Submission Details

510(k) Number K193545 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 2019
Decision Date August 04, 2020
Days to Decision 228 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
106d slower than avg
Panel avg: 122d · This submission: 228d
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 Consultant

Corin (Australia)
Crissy Tomarelli

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - LZO Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented

All 308
Devices cleared under the same product code (LZO) and FDA review panel - the closest regulatory comparables to K193545.
DePuy Corail AMT Hip Prosthesis
K203167 · DePuy Orthopaedics, Inc. · Nov 2020
SMS Cementless Stem
K201673 · Medacta International S.A. · Sep 2020
Spartan Hip Stem
K192883 · Signature Orthopaedics Pty, Ltd. · Aug 2020
Cemented Origin Hip Stem
K201951 · Signature Orthopaedics Pty, Ltd. · Jul 2020
Biolox® delta Ceramic Heads, Biolox® delta Option Ceramic Heads MR Labeling
K200959 · Biomet UK, Ltd. · Jul 2020
Cemented TSI Hip Stem
K192024 · Signature Orthopaedics Pty, Ltd. · Jun 2020