ITOTAL CRUCIATE RETAINING, IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEMS, IDUO BICOMPARTMENTAL KNEE REPAIR SYSTEM

Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer

CONFORMIS, INC.

The following data is part of a premarket notification filed by Conformis, Inc. with the FDA for Itotal Cruciate Retaining, Iuni Unicondylar Knee Replacement Systems, Iduo Bicompartmental Knee Repair System.

Pre-market Notification Details

• Device ID: K133256
• 510k Number: K133256
• Device Name: ITOTAL CRUCIATE RETAINING, IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEMS, IDUO BICOMPARTMENTAL KNEE REPAIR SYSTEM
• Classification: Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
• Applicant: CONFORMIS, INC. 28 Crosby Dr Bedford, MA 01730
• Contact: Anita Shah
• Correspondent: Anita Shah; CONFORMIS, INC. 28 Crosby Dr Bedford, MA 01730
• Product Code: JWH
• Subsequent Product Code: HSX
• Subsequent Product Code: NPJ
• Subsequent Product Code: OOG
• CFR Regulation Number: 888.3560 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2013-10-23
• Decision Date: 2014-01-09
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00850268007439	K133256	000
00850268007422	K133256	000
00850268007415	K133256	000
00850268007408	K133256	000
00850268007392	K133256	000
00850268007385	K133256	000
00850268007378	K133256	000
00850268007361	K133256	000