Cleared Traditional

ACHIEVE Partial Knee System

K242307 · Ignite Orthomotion · Orthopedic
Dec 2024
Decision
133d
Days
Class 2
Risk

About This 510(k) Submission

K242307 is an FDA 510(k) clearance for the ACHIEVE Partial Knee System, 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 December 16, 2024, 133 days after receiving the submission on August 5, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3535.

Submission Details

510(k) Number K242307 FDA.gov
FDA Decision Cleared SESE
Date Received August 05, 2024
Decision Date December 16, 2024
Days to Decision 133 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.