Cleared Traditional

K994214 - GEM KNEE SYSTEM

K994214 is an FDA 510(k) clearance for GEM 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 218-day FDA review.

K994214 · Kinamed, Inc. · Orthopedic device
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Jul 2000
Decision
218d
Days
Class 2
Risk

K994214 is an FDA 510(k) clearance for the GEM KNEE SYSTEM. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Kinamed, Inc. (Potomac, US). The FDA issued a Cleared decision on July 19, 2000 after a review of 218 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 Kinamed, Inc. devices

FDA 510(k) Submission Details - K994214

510(k) Number K994214 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 1999
Decision Date July 19, 2000
Days to Decision 218 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
96d slower than avg
Panel avg: 122d · This submission: 218d
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 K994214.
ASCENT KNEE SYSTEM
K002678 · Biomet, Inc. · Sep 2000
ASCENT XXL OPEN BOX FEMORAL COMPONENT
K002735 · Biomet, Inc. · Sep 2000
STELKAST PROVEN KNEE SYSTEM
K002281 · Stelkast Company · Aug 2000
ANATOMIC TOTAL KNEE PROSTHESIS
K000978 · Biomet, Inc. · Jun 2000
CONTINUUM KNEE SYSTEM-PS FEMORAL COMPONENTS- POROUS, MODEL XX-YYY-ZZZZZ
K001307 · Implex Corp. · May 2000
LATERAL PIVOT INSERT
K000590 · Encore Orthopedics, Inc. · May 2000