Cleared Traditional

K010101 - GEM POSTERIOR STABILIZED TOTAL KNEE SYSTEM

K010101 is an FDA 510(k) clearance for GEM POSTERIOR STABILIZED TOTAL KNEE SYSTEM, manufactured by Kinamed, Inc.. The device is a Class 2 Orthopedic device with product code JWH cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K010101 · Kinamed, Inc. · Orthopedic device
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May 2001
Decision
126d
Days
Class 2
Risk

K010101 is an FDA 510(k) clearance for the GEM POSTERIOR STABILIZED TOTAL KNEE SYSTEM. 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 May 17, 2001 after a review of 126 days - within the typical 510(k) review window.

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 Kinamed, Inc. devices

FDA 510(k) Submission Details - K010101

510(k) Number K010101 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 2001
Decision Date May 17, 2001
Days to Decision 126 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
4d slower than avg
Panel avg: 122d · This submission: 126d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JWH Device Classification - Class 2, Special Controls

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 895
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K010101.
TC-PLUS POROUS FEMORAL COMPONENTS
K011258 · Plus Orthopedics · May 2001
TC-PLUS POROUS TIBIAL COMPONENTS
K011288 · Plus Orthopedics · May 2001
ASCENT KNEE SYSTEM
K011219 · Biomet, Inc. · May 2001
NEXGEN COMPLETE KNEE SOLUTION CROSS-LINKED POLYETHYLENE CRUCIATE RETAINING (CR) ARTICULAR SURFACE COMPONENTS
K003910 · Zimmer, Inc. · Mar 2001
OPTETRAK B-SERIES TOTAL KNEE SYSTEM
K010434 · Exactech, Inc. · Mar 2001
ENHANCED POLYETHYLENE KNEE PROSTHESES
K001147 · Howmedica Osteonics Corp. · Feb 2001