Cleared Traditional

HOWMEDICA TOTAL STABILIZER KNEE COMPONENTS

K973164 · Howmedica Corp. · Orthopedic

Nov 1997

Decision

87d

Days

Class 2

Risk

About This 510(k) Submission

K973164 is an FDA 510(k) clearance for the HOWMEDICA TOTAL STABILIZER KNEE COMPONENTS, a Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (Class II — Special Controls, product code JWH), submitted by Howmedica Corp. (Rutherford, US). The FDA issued a Cleared decision on November 20, 1997, 87 days after receiving the submission on August 25, 1997. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3560.

Submission Details

510(k) Number	K973164 FDA.gov
FDA Decision	Cleared SN
Date Received	August 25, 1997
Decision Date	November 20, 1997
Days to Decision	87 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