Achieve Partial Knee System - Porous Coated CoCrMo Femoral Component— 510(k) K251975

Name: FDA 510(k) clearance K251975
Creator: U.S. Food and Drug Administration
Published: 2025-09-02

Substantially Equivalent

Ignite Orthomotion

FDA 510(k) clearance K251975 for Achieve Partial Knee System - Porous Coated CoCrMo Femoral Component, Substantially Equivalent on 2025-09-02. Applicant: Ignite Orthomotion. Device class: 2.

Clearance details

Applicant: Ignite Orthomotion
Product code: Code NJD
Device class: Class 2
Regulation: 21 CFR 888.3535
Advisory panel: Orthopedic
Date received: 2025-06-26
Decision date: 2025-09-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Winona Lake, IN, US

Download summary PDF View on FDA.gov ↗

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