NextAR TKA Platform— 510(k) K193559

Substantially Equivalent

Medacta Inernational SA

FDA 510(k) clearance K193559 for NextAR TKA Platform, Substantially Equivalent on 2020-07-10. Applicant: Medacta Inernational SA. Device class: 2.

Clearance details

Applicant: Medacta Inernational SA
Product code: Code SBF
Device class: Class 2
Regulation: 21 CFR 882.4560
Advisory panel: Neurology
Date received: 2019-12-23
Decision date: 2020-07-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Castel San Pietro (Ch), CH

Download summary PDF View on FDA.gov ↗

Recent devices under product code SBF

K261854 — xvision Spine system2026-07-31
K253805 — Knee+2026-04-24
K252847 — NextAR Hip Platform2026-01-09
K251639 — xvision Spine system2025-10-03
K252054 — SpineAR SNAP (SyncAR Spine)2025-09-29

More clearances from Medacta Inernational SA

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K193175 — Lateralized Glenosphere2020-08-11

Data sourced from openFDA. This site is unofficial and independent of the FDA.