Cleared Traditional

GENESIS POSTERIOR STABILIZED (P/S) KNEE SYSTEM (K946088) - FDA 510(k) Clearance

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

K946088 · Smith & Nephew Richards, Inc. · Orthopedic device
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Aug 1995
Decision
238d
Days
Class 2
Risk

K946088 is an FDA 510(k) clearance for the GENESIS POSTERIOR STABILIZED (P/S) KNEE SYSTEM. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Smith & Nephew Richards, Inc. (Memphis, US). The FDA issued a Cleared decision on August 8, 1995 after a review of 238 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 Smith & Nephew Richards, Inc. devices

Submission Details

510(k) Number K946088 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 1994
Decision Date August 08, 1995
Days to Decision 238 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
116d slower than avg
Panel avg: 122d · This submission: 238d
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 K946088.
PCA(R) MODULAR TOTAL KNEE TIB INSERT DUROCON BASEPLATE
K940861 · Howmedica Corp. · Sep 1995
OSTEONICS SERIES 7000 TOTAL KNEE FULL TIBIAL BONE AUGEMENTATION BLOCKS & WEDGES
K951956 · Osteonics Corp. · Aug 1995
DURACON BASEPLATES
K936008 · Howmedica Corp. · Aug 1995
DEPUY AMK CO-CR FINNED TIBIAL TRAY
K951027 · Depuy, Inc. · Jul 1995
CRUCIATE RETAINING (AUGMENTABLE) AND CONSTRAINED CONDYLAR KNEE (CCK)
K946150 · Zimmer, Inc. · Jul 1995
DURACON RECESSED PATELLA
K951655 · Howmedica Corp. · Jul 1995