Cleared Traditional

Achieve Partial Knee System - Porous Coated CoCrMo Femoral Component

K251975 · Ignite Orthomotion · Orthopedic
Sep 2025
Decision
68d
Days
Class 2
Risk

About This 510(k) Submission

K251975 is an FDA 510(k) clearance for the Achieve Partial Knee System - Porous Coated CoCrMo Femoral Component, a Prosthesis, Knee, Femorotibial, Unicompartmental/unicondylar, Uncemented, Porous-coated, Metal/polymer (Class II — Special Controls, product code NJD), submitted by Ignite Orthomotion (Winona Lake, US). The FDA issued a Cleared decision on September 2, 2025, 68 days after receiving the submission on June 26, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3535.

Submission Details

510(k) Number K251975 FDA.gov
FDA Decision Cleared SESE
Date Received June 26, 2025
Decision Date September 02, 2025
Days to Decision 68 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code NJD — Prosthesis, Knee, Femorotibial, Unicompartmental/unicondylar, Uncemented, Porous-coated, Metal/polymer
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3535
Definition Intended To Replace Part Of A Knee Joint In Order To Relieve Pain And Restore Knee Function, For Indications Such As Uni-compartmental Osteoarthritis; Inflammatory Arthritis; Traumatic Arthritis; Varus, Valgus Or Flexion Deformities; And Revision Surgery.