Cleared Traditional

K871146 - GUSTILO/RAND TOTAL KNEE SYSTEM (GENESIS)

K871146 is an FDA 510(k) clearance for GUSTILO/RAND TOTAL KNEE SYSTEM (GENESIS), manufactured by Richards Medical Co., Inc.. The device is a Class 2 Orthopedic device with product code JWH cleared through the Traditional 510(k) pathway after a 130-day FDA review.

K871146 · Richards Medical Co., Inc. · Orthopedic device
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Jul 1987
Decision
130d
Days
Class 2
Risk

K871146 is an FDA 510(k) clearance for the GUSTILO/RAND TOTAL KNEE SYSTEM (GENESIS). Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Richards Medical Co., Inc. (Memphis, US). The FDA issued a Cleared decision on July 31, 1987 after a review of 130 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 Richards Medical Co., Inc. devices

FDA 510(k) Submission Details - K871146

510(k) Number K871146 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 1987
Decision Date July 31, 1987
Days to Decision 130 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
8d slower than avg
Panel avg: 122d · This submission: 130d
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 800
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K871146.
HOWMEDICA KINEMATIC II MODULAR TIBIAL COMPONENT
K871349 · Howmedica Corp. · Sep 1987
CLARIFIED APPLICA. FOR LACEY CONDYLAR TOTAL KNEE
K872266 · Dow Corning Wright · Aug 1987
WHITESIDE ORTHOLOC II REV POST STAB TOTAL KNEE SY
K871776 · Dow Corning Wright · Aug 1987
MODIFIED ANATOMIC MODULAR KNEE (AMK) SYSTEM
K871585 · Depuy, Inc. · Jul 1987
LACEY METAL BACKED PATELLA PROSTHESIS
K870273 · Dow Corning Wright · Jul 1987
KINEMATIC III POST CRUCIATE TOTAL CONDYLAR KNEE SY
K871772 · Howmedica Corp. · Jun 1987