Cleared Traditional

FEMORAL AND TIBIAL PLUGS OF INTERAX TOTAL KNEE SYSTEM

K980713 · Howmedica Corp. · Orthopedic

May 1998

Decision

87d

Days

Class 2

Risk

About This 510(k) Submission

K980713 is an FDA 510(k) clearance for the FEMORAL AND TIBIAL PLUGS OF 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 May 22, 1998, 87 days after receiving the submission on February 24, 1998. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3560.

Submission Details

510(k) Number	K980713 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 24, 1998
Decision Date	May 22, 1998
Days to Decision	87 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