Cleared Traditional

GEM INSET PATELLAR COMPONENT (K032950) - FDA 510(k) Clearance

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

K032950 · Kinamed, Inc. · Orthopedic device
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Dec 2003
Decision
88d
Days
Class 2
Risk

K032950 is an FDA 510(k) clearance for the GEM INSET PATELLAR COMPONENT. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Kinamed, Inc. (Camarillo, US). The FDA issued a Cleared decision on December 19, 2003 after a review of 88 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Kinamed, Inc. devices

Submission Details

510(k) Number K032950 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 2003
Decision Date December 19, 2003
Days to Decision 88 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
34d faster than avg
Panel avg: 122d · This submission: 88d
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 522
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K032950.
DEPUY SIGMA TIBIAL INSERTS
K033272 · DePuy Orthopaedics, Inc. · Feb 2004
SCORPIO KNEE SYSTEM - TIBIAL INSERTS
K033342 · Howmedica Osteonics Corp. · Jan 2004
ADVANCE DOUBLE HIGH INSERT
K033890 · Wrightmedicaltechnologyinc · Jan 2004
SCORPIO LOW PROFILE TIBIAL TRAY
K032829 · Howmedica Osteonics Corp. · Dec 2003
SCORPIO NRG KNEE SYSTEM
K030978 · Howmedica Osteonics Corp. · Nov 2003
DEPUY SIGMA TIBIAL INSERTS AND CO-CR TIBIAL TRAYS
K032151 · Depuy, Inc. · Sep 2003