ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella, And Medialized Anatomic Patella With AFFIXIUM™ 3DP Technology

Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer

DePuy Ireland UC

The following data is part of a premarket notification filed by Depuy Ireland Uc with the FDA for Attune® Porous Fixed Bearing Tibial Base, Medialized Dome Patella, And Medialized Anatomic Patella With Affixium™ 3dp Technology.

Pre-market Notification Details

• Device ID: K202194
• 510k Number: K202194
• Device Name: ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella, And Medialized Anatomic Patella With AFFIXIUM™ 3DP Technology
• Classification: Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer
• Applicant: DePuy Ireland UC Loughbeg Ringaskiddy Co. Cork, IE
• Contact: Erin Combs
• Correspondent: Kathy Boggs; DePuy Orthopaedic, Inc. 700 Orthopaedic Drive Warsaw, IN 46582
• Product Code: MBH
• CFR Regulation Number: 888.3565 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2020-08-05
• Decision Date: 2020-11-25

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10603295523789	K202194	000
10603295507406	K202194	000
10603295507413	K202194	000
10603295507420	K202194	000
10603295507437	K202194	000
10603295507444	K202194	000
10603295507451	K202194	000
10603295507468	K202194	000
10603295507475	K202194	000
10603295507482	K202194	000
10603295523604	K202194	000
10603295523611	K202194	000
10603295523628	K202194	000
10603295523635	K202194	000
10603295523758	K202194	000
10603295523765	K202194	000
10603295523772	K202194	000
10603295507390	K202194	000