Cleared Traditional

INTERAX TOTAL KNEE SYSTEM

K973121 · Howmedica Corp. · Orthopedic

Nov 1997

Decision

90d

Days

Class 2

Risk

About This 510(k) Submission

K973121 is an FDA 510(k) clearance for the INTERAX TOTAL KNEE SYSTEM, 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 18, 1997, 90 days after receiving the submission on August 20, 1997. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3560.

Submission Details

510(k) Number	K973121 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 20, 1997
Decision Date	November 18, 1997
Days to Decision	90 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

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