Cleared Traditional

POROUS GENESIS STEMMED TIBIAL COMPONENT

K892366 · Richards Medical Co., Inc. · Orthopedic

Jul 1989

Decision

104d

Days

Class 2

Risk

About This 510(k) Submission

K892366 is an FDA 510(k) clearance for the POROUS GENESIS STEMMED TIBIAL COMPONENT, 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, 104 days after receiving the submission on April 6, 1989. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3560.

Submission Details

510(k) Number	K892366 FDA.gov
FDA Decision	Cleared SN
Date Received	April 06, 1989
Decision Date	July 19, 1989
Days to Decision	104 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