Cleared Special

IDUO BICOMPARTMENTAL KNEE REPAIR SYSTEM

K093513 · Conformis, Inc. · Orthopedic

Dec 2009

Decision

33d

Days

Class 2

Risk

About This 510(k) Submission

K093513 is an FDA 510(k) clearance for the IDUO BICOMPARTMENTAL KNEE REPAIR SYSTEM, a Prosthesis, Knee Patellofemorotibial, Partial, Semi-constrained, Cemented, Polymer/metal/polymer (Class II — Special Controls, product code NPJ), submitted by Conformis, Inc. (Burlington, US). The FDA issued a Cleared decision on December 16, 2009, 33 days after receiving the submission on November 13, 2009. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3560.

Submission Details

510(k) Number	K093513 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 13, 2009
Decision Date	December 16, 2009
Days to Decision	33 days
Submission Type	Special
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	NPJ — Prosthesis, Knee Patellofemorotibial, Partial, Semi-constrained, Cemented, Polymer/metal/polymer
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3560
Definition	The Device Is Intended To Replace The Medial Condyle And The Patellofemoral Compartment Of The Distal Femur With A Single Device. The Device Is Meant To Be Used With A Uni-compartmental Tibial Base And Insert And A Resurfacing Patella. The Device Is Intended To Be Used With Bone Cement.