Cleared Traditional

POROUS COATED GENESIS FEMORAL COMPONENT

K885036 · Richards Medical Co., Inc. · Orthopedic

Apr 1989

Decision

135d

Days

Class 2

Risk

About This 510(k) Submission

K885036 is an FDA 510(k) clearance for the POROUS COATED GENESIS FEMORAL 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 April 19, 1989, 135 days after receiving the submission on December 5, 1988. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3560.

Submission Details

510(k) Number	K885036 FDA.gov
FDA Decision	Cleared SN
Date Received	December 05, 1988
Decision Date	April 19, 1989
Days to Decision	135 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