K251975

Achieve Partial Knee System - Porous Coated CoCrMo Femoral Component

510(k) number: K251975
Device name: Achieve Partial Knee System - Porous Coated CoCrMo Femoral Component
Applicant: Ignite Orthomotion IN · US
Product code: NJD — Prosthesis, Knee, Femorotibial, Unicompartmental/Uni
Decision date: 2025-09-02
Date received: 2025-06-26
Decision: Substantially Equivalent
Clearance type: Traditional
Advisory committee: Orthopedic

Also available from FDA: K251975.pdf

Official FDA record: K251975

Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.