Cleared Traditional

DURACON(R) SMALL STABILIZER TIBIAL INSERT

K974843 · Howmedica Corp. · Orthopedic

Jun 1998

Decision

176d

Days

Class 2

Risk

About This 510(k) Submission

K974843 is an FDA 510(k) clearance for the DURACON(R) SMALL STABILIZER TIBIAL INSERT, 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 June 18, 1998, 176 days after receiving the submission on December 24, 1997. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3560.

Submission Details

510(k) Number	K974843 FDA.gov
FDA Decision	Cleared SN
Date Received	December 24, 1997
Decision Date	June 18, 1998
Days to Decision	176 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