Cleared Traditional

POROUS GENESIS PATELLAR AND STEMLESS TIBIAL COMP.

K890132 · Richards Medical Co., Inc. · Orthopedic

Jul 1989

Decision

188d

Days

Class 2

Risk

About This 510(k) Submission

K890132 is an FDA 510(k) clearance for the POROUS GENESIS PATELLAR AND STEMLESS TIBIAL COMP., a Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (Class II — Special Controls, product code JWH), submitted by Richards Medical Co., Inc. (Memphus, US). The FDA issued a Cleared decision on July 19, 1989, 188 days after receiving the submission on January 12, 1989. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3560.

Submission Details

510(k) Number	K890132 FDA.gov
FDA Decision	Cleared SN
Date Received	January 12, 1989
Decision Date	July 19, 1989
Days to Decision	188 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	—

Device Classification

Product Code	JWH — Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3560