Cleared Traditional

DURATION II TIBIAL INSERTS - GAS PLASMA STERILIZATION

K980632 · Howmedica Corp. · Orthopedic

Dec 1998

Decision

295d

Days

Class 2

Risk

About This 510(k) Submission

K980632 is an FDA 510(k) clearance for the DURATION II TIBIAL INSERTS - GAS PLASMA STERILIZATION, 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 December 11, 1998, 295 days after receiving the submission on February 19, 1998. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3560.

Submission Details

510(k) Number	K980632 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 19, 1998
Decision Date	December 11, 1998
Days to Decision	295 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