Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

NextAR Hip Platform

K-Number: K252847 · 2026-01-09

Decision Date2026-01-09
Product CodeSBF
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NextAR Hip Platform is the device name listed in this FDA 510(k) record. The listed applicant is Medacta International S.A.. It received FDA 510(k) clearance on 2026-01-09 under 510(k) number K252847. The device is classified under product code SBF. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NextAR Hip Platform?

NextAR Hip Platform is a medical device that received FDA 510(k) clearance on 2026-01-09. The listed applicant is Medacta International S.A.. The 510(k) number is K252847.

When did NextAR Hip Platform receive FDA 510(k) clearance?

NextAR Hip Platform received FDA 510(k) clearance on 2026-01-09, under 510(k) number K252847.

Who is the listed applicant for NextAR Hip Platform?

The FDA 510(k) record lists Medacta International S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NextAR Hip Platform?

The FDA product code for NextAR Hip Platform is SBF.

Other records listing Medacta International S.A. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

View all 146 devices →

Related Devices (Code: SBF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.