Cleared Traditional

CORIN UNIPOLAR MODULAR HEAD (K063791) - FDA 510(k) Clearance

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

K063791 · Corin USA · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2007
Decision
102d
Days
Class 2
Risk

K063791 is an FDA 510(k) clearance for the CORIN UNIPOLAR MODULAR HEAD. Classified as Prosthesis, Hip, Hemi-, Femoral, Metal (product code KWL), Class II - Special Controls.

Submitted by Corin USA (Tampa, US). The FDA issued a Cleared decision on April 3, 2007 after a review of 102 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3360 - 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 K063791 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 2006
Decision Date April 03, 2007
Days to Decision 102 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
20d faster than avg
Panel avg: 122d · This submission: 102d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KWL Prosthesis, Hip, Hemi-, Femoral, Metal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3360
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 - KWL Prosthesis, Hip, Hemi-, Femoral, Metal

All 55
Devices cleared under the same product code (KWL) and FDA review panel - the closest regulatory comparables to K063791.
REMEDY PLUS Hip Spacer, UNITE PLUS Bone Cement
K172906 · Osteoremedies, LLC · Aug 2018
Remedy Acetabular Cup
K173967 · Osteoremedies, LLC · Feb 2018
CORIN ADAPTOR SLEEVE
K071471 · Howmedica Osteonics Corp. · Sep 2007
SMITH & NEPHEW MODULAR FEMORAL (HEMI) HEAD
K062408 · Smith & Nephew, Inc. · Sep 2006
SMITH & NEPHEW MODULAR FEMORAL HEAD
K061243 · Smith & Nephew, Inc. · Jul 2006
SPACER G TEMPORARY HIP PROSTHESIS
K031841 · Exactech, Inc. · Jan 2004