Cleared Traditional

K242307 - ACHIEVE Partial Knee System

K242307 is an FDA 510(k) clearance for ACHIEVE Partial Knee System, manufactured by Ignite Orthomotion. The device is a Class 2 Orthopedic device with product code NJD cleared through the Traditional 510(k) pathway after a 133-day FDA review.

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

K242307 is an FDA 510(k) clearance for the ACHIEVE Partial Knee System. Classified as Prosthesis, Knee, Femorotibial, Unicompartmental/unicondylar, Uncemented, Porous-coated, Metal/polymer (product code NJD), Class II - Special Controls.

Submitted by Ignite Orthomotion (Winona Lake, US). The FDA issued a Cleared decision on December 16, 2024 after a review of 133 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3535 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Ignite Orthomotion devices

FDA 510(k) Submission Details - K242307

510(k) Number K242307 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
11d slower than avg
Panel avg: 122d · This submission: 133d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NJD Device Classification - Class 2, Special Controls

Product Code NJD Prosthesis, Knee, Femorotibial, Unicompartmental/unicondylar, Uncemented, Porous-coated, Metal/polymer
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - NJD Prosthesis, Knee, Femorotibial, Unicompartmental/unicondylar, Uncemented, Porous-coated, Metal/polymer

Devices cleared under the same product code (NJD) and FDA review panel - the closest regulatory comparables to K242307.
Achieve Partial Knee System - Porous Coated CoCrMo Femoral Component
K251975 · Ignite Orthomotion · Sep 2025
JOURNEY II UK™ and ENGAGE™ Cementless Partial Knee System
K222653 · Smith & Nephew, Inc. · Oct 2022
Engage™ Partial Knee System
K190439 · Engage Uni, LLC · Nov 2019
RESTORIS POROUS PARTIAL KNEE SYSTEM
K133811 · Mako Surgical Corp. · Jul 2014