Cleared Traditional

K890132 - POROUS GENESIS PATELLAR AND STEMLESS TI...

K890132 is an FDA 510(k) clearance for POROUS GENESIS PATELLAR AND STEMLESS TI..., 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 188-day FDA review.

K890132 · Richards Medical Co., Inc. · Orthopedic device
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Jul 1989
Decision
188d
Days
Class 2
Risk

K890132 is an FDA 510(k) clearance for the POROUS GENESIS PATELLAR AND STEMLESS TIBIAL COMP.. 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 19, 1989 after a review of 188 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 Richards Medical Co., Inc. devices

FDA 510(k) Submission Details - K890132

510(k) Number K890132 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received January 12, 1989
Decision Date July 19, 1989
Days to Decision 188 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
66d slower than avg
Panel avg: 122d · This submission: 188d
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 K890132.
PLUS TOTAL KNEE SYSTEM, (PPD) TIBIAL COMPONENT
K893762 · Orthomet, Inc. · Sep 1989
MG II POROUS TOTAL KNEE SYSTEM
K892800 · Zimmer, Inc. · Aug 1989
WHITESIDE ORTHOLOC M.A. TOTAL KNEE SYSTEM
K893252 · Dow Corning Wright · Jul 1989
POROUS GENESIS STEMMED TIBIAL COMPONENT
K892366 · Richards Medical Co., Inc. · Jul 1989
P.F.C. MODULAR KNEE SYSTEM, TIBIAL TRAY-POROUS
K892394 · Johnson & Johnson Professionals, Inc. · Jul 1989
POROUS COATED GENESIS FEMORAL COMPONENT
K885036 · Richards Medical Co., Inc. · Apr 1989