Cleared Traditional

K071471 - CORIN ADAPTOR SLEEVE

K071471 is an FDA 510(k) clearance for CORIN ADAPTOR SLEEVE, manufactured by Howmedica Osteonics Corp.. The device is a Class 2 Orthopedic device with product code KWL cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K071471 · Howmedica Osteonics Corp. · Orthopedic device
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Sep 2007
Decision
104d
Days
Class 2
Risk

K071471 is an FDA 510(k) clearance for the CORIN ADAPTOR SLEEVE. Classified as Prosthesis, Hip, Hemi-, Femoral, Metal (product code KWL), Class II - Special Controls.

Submitted by Howmedica Osteonics Corp. (Mahwah, US). The FDA issued a Cleared decision on September 10, 2007 after a review of 104 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 Howmedica Osteonics Corp. devices

FDA 510(k) Submission Details - K071471

510(k) Number K071471 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 29, 2007
Decision Date September 10, 2007
Days to Decision 104 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
18d faster than avg
Panel avg: 122d · This submission: 104d
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 91
Devices cleared under the same product code (KWL) and FDA review panel - the closest regulatory comparables to K071471.
Evolve UniPolar Head
K143184 · Signature Orthopaedics Pty, Ltd. · Mar 2015
2GC HIP/KNEE MODULAR SPACER
K112470 · Mandell Horwitz Consultants, LLC · Apr 2012
CORIN OPTIMOM MODULAR HEAD
K111911 · Corin USA · Aug 2011
CORIN UNIPOLAR MODULAR HEAD
K063791 · Corin USA · Apr 2007
SMITH & NEPHEW MODULAR FEMORAL (HEMI) HEAD
K062408 · Smith & Nephew, Inc. · Sep 2006
SMITH & NEPHEW MODULAR FEMORAL HEAD
K061243 · Smith & Nephew, Inc. · Jul 2006