Cleared Traditional

K051976 - PROVEN REVISION MODULAR TIBIAL TRAY
(FDA 510(k) Clearance)

K051976 · Stelkast Company · Orthopedic

Oct 2005

Decision

88d

Days

Class 2

Risk

K051976 is an FDA 510(k) clearance for the PROVEN REVISION MODULAR TIBIAL TRAY, a Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (Class II — Special Controls, product code JWH), submitted by Stelkast Company (Mcmurray, US). The FDA issued a Cleared decision on October 17, 2005, 88 days after receiving the submission on July 21, 2005. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3560.

Submission Details

510(k) Number	K051976 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 21, 2005
Decision Date	October 17, 2005
Days to Decision	88 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Statement

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