Cleared Traditional

K063791 - CORIN UNIPOLAR MODULAR HEAD

K063791 is an FDA 510(k) clearance for CORIN UNIPOLAR MODULAR HEAD, manufactured by Corin USA. The device is a Class 2 Orthopedic device with product code KWL cleared through the Traditional 510(k) pathway after a 102-day FDA review.

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

FDA 510(k) Submission Details - K063791

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
Combination Product No
PCCP Authorized No
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.

KWL Device Classification - Class 2, Special Controls

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 83
Devices cleared under the same product code (KWL) and FDA review panel - the closest regulatory comparables to K063791.
Evolve UniPolar Head
K143184 · Signature Orthopaedics Pty, Ltd. · Mar 2015
CORIN OPTIMOM MODULAR HEAD
K111911 · Corin USA · Aug 2011
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
SOLITUDE UNIPOLAR HEAD
K042973 · Ortho Development Corp. · Jan 2005