NextAR™ TKA Platform My Knee PPS

Orthopedic Stereotaxic Instrument

Medacta International S.A.

The following data is part of a premarket notification filed by Medacta International S.a. with the FDA for Nextar™ Tka Platform My Knee Pps.

Pre-market Notification Details

• Device ID: K213751
• 510k Number: K213751
• Device Name: NextAR™ TKA Platform My Knee PPS
• Classification: Orthopedic Stereotaxic Instrument
• Applicant: Medacta International S.A. Strada Regina Castel San Pietro, CH Ch-6874
• Contact: Stefano Baj
• Correspondent: Chris Lussier; Medacta USA 3973 Delp Street Memphis, TN 38118
• Product Code: OLO
• Subsequent Product Code: JWH
• Subsequent Product Code: PBF
• CFR Regulation Number: 882.4560 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2021-11-30
• Decision Date: 2022-03-10

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
07630345731807	K213751	000
07630345731791	K213751	000
07630345731784	K213751	000
07630345731777	K213751	000
07630345731678	K213751	000
07630345731661	K213751	000
07630345731654	K213751	000
07630345731647	K213751	000