Cleared Special

K071991 - MODIFICATION TO SCORPIO NRG KNEE SYSTEM

K071991 is the FDA 510(k) clearance for MODIFICATION TO SCORPIO NRG KNEE SYSTEM by Howmedica Osteonics Corp.. It is a Class 2 Orthopedic device (product code JWH) cleared through the Special 510(k) pathway after a 26-day FDA review.

K071991 · Howmedica Osteonics Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2007
Decision
26d
Days
Class 2
Risk

K071991 is an FDA 510(k) clearance for the MODIFICATION TO SCORPIO NRG KNEE SYSTEM. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Howmedica Osteonics Corp. (Mahwah, US). The FDA issued a Cleared decision on August 15, 2007 after a review of 26 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3560 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Howmedica Osteonics Corp. devices

Submission Details

510(k) Number K071991 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 2007
Decision Date August 15, 2007
Days to Decision 26 days
Submission Type Special
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
96d faster than avg
Panel avg: 122d · This submission: 26d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code JWH Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3560
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 - JWH Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer

All 786
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K071991.
CROSSLINKED POLYETHYLENE ARTICULAR INSERTS
K071071 · Smith & Nephew, Inc. · Sep 2007
NEXGEN PROLONG ALL-POLY PATELLA
K072281 · Zimmer, Inc. · Sep 2007
EXACTECH OPTETRAK PROXIMAL TIBIAL SPACER
K071738 · Exactech, Inc. · Aug 2007
TRIATHLON TS KNEE SYSTEM
K070095 · Howmedica Osteonics Corp. · Jun 2007
DEPUY KNEE PROSTHESIS SYSTEM UNIVERSAL STEM EXTENSIONS AND FEMORAL METAPHYSEAL SLEEVES
K063633 · DePuy Orthopaedics, Inc. · Mar 2007
PROVEN KNEE SYSTEM HIGH FLEXION TIBIAL INSERT
K063211 · Stelkast Company · Jan 2007