Cleared Traditional

K020703 - SCORPIO CR AND PS CO CR FEMORAL COMPONE...

K020703 is the FDA 510(k) clearance for SCORPIO CR AND PS CO CR FEMORAL COMPONE... by Howmedica Osteonics Corp.. It is a Class 2 Orthopedic device (product code JWH) cleared through the Traditional 510(k) pathway after a 254-day FDA review.

K020703 · Howmedica Osteonics Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2002
Decision
254d
Days
Class 2
Risk

K020703 is an FDA 510(k) clearance for the SCORPIO CR AND PS CO CR FEMORAL COMPONENTS WITH TITANIUM PLASMA SPRAY COATING. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Howmedica Osteonics Corp. (Allendale, US). The FDA issued a Cleared decision on November 13, 2002 after a review of 254 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3560 - 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

Submission Details

510(k) Number K020703 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 2002
Decision Date November 13, 2002
Days to Decision 254 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
132d slower than avg
Panel avg: 122d · This submission: 254d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 778
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K020703.
NEXGEN COMPLETE KNEE SOLUTION - TRABECULAR METAL AUGMENTS
K024161 · Implex Corp. · Jan 2003
NARROW ASCENT INTERLOK FEMORAL COMPONENTS
K024037 · Biomet, Inc. · Dec 2002
COLUMBUS (CR) TOTAL KNEE SYSTEM
K023788 · Aesculap, Inc. · Dec 2002
COLUMBUS TOTAL KNEE SYSTEM (CR)
K022672 · Aesculap, Inc. · Nov 2002
MODIFICATION TO VKS KNEE SYSTEM
K023416 · Plus Orthopedics · Nov 2002
DURACON CS TIBIAL INSERT
K021451 · Howmedica Osteonics Corp. · Oct 2002