Cleared Special

HLS KNEETEC SYSTEM

K094013 · Tornier · Orthopedic

May 2011

Decision

492d

Days

Class 2

Risk

About This 510(k) Submission

K094013 is an FDA 510(k) clearance for the HLS KNEETEC SYSTEM, a Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (Class II — Special Controls, product code JWH), submitted by Tornier (Monbonnot Saint Martin, FR). The FDA issued a Cleared decision on May 5, 2011, 492 days after receiving the submission on December 29, 2009. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3560.

Submission Details

510(k) Number	K094013 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 29, 2009
Decision Date	May 05, 2011
Days to Decision	492 days
Submission Type	Special
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