FDA 510(k)

ACHIEVE Partial Knee System

K-Number: K242307 · 2024-12-16

Decision Date2024-12-16

Product CodeNJD

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

ACHIEVE Partial Knee System is the device name listed in this FDA 510(k) record. The listed applicant is Ignite Orthomotion. It received FDA 510(k) clearance on 2024-12-16 under 510(k) number K242307. The device is classified under product code NJD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACHIEVE Partial Knee System?

ACHIEVE Partial Knee System is a medical device that received FDA 510(k) clearance on 2024-12-16. The listed applicant is Ignite Orthomotion. The 510(k) number is K242307.

When did ACHIEVE Partial Knee System receive FDA 510(k) clearance?

ACHIEVE Partial Knee System received FDA 510(k) clearance on 2024-12-16, under 510(k) number K242307.

Who is the listed applicant for ACHIEVE Partial Knee System?

The FDA 510(k) record lists Ignite Orthomotion as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACHIEVE Partial Knee System?

The FDA product code for ACHIEVE Partial Knee System is NJD.

Other records listing Ignite Orthomotion as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251975Achieve Partial Knee System - Porous Coated CoCrMo Femoral Component

Related Devices (Code: NJD)

K251975Achieve Partial Knee System - Porous Coated CoCrMo Femoral ComponentIgnite Orthomotion K222653JOURNEY II UK™ and ENGAGE™ Cementless Partial Knee SystemSmith+Nephew, Inc.K190439Engage™ Partial Knee SystemEngage Uni, LLC

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.