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FDA 510(k)

Achieve Partial Knee System - Porous Coated CoCrMo Femoral Component

K-Number: K251975 · 2025-09-02

ApplicantIgnite Orthomotion
Decision Date2025-09-02
Product CodeNJD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Achieve Partial Knee System - Porous Coated CoCrMo Femoral Component is a medical device manufactured by Ignite Orthomotion. It received FDA 510(k) clearance on 2025-09-02 under approval number K251975. 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 - Porous Coated CoCrMo Femoral Component?

Achieve Partial Knee System - Porous Coated CoCrMo Femoral Component is a medical device that received FDA 510(k) clearance on 2025-09-02. It is manufactured by Ignite Orthomotion. The 510(k) number is K251975.

When was Achieve Partial Knee System - Porous Coated CoCrMo Femoral Component approved by the FDA?

Achieve Partial Knee System - Porous Coated CoCrMo Femoral Component received FDA 510(k) clearance on 2025-09-02, under approval number K251975.

What company makes Achieve Partial Knee System - Porous Coated CoCrMo Femoral Component?

Achieve Partial Knee System - Porous Coated CoCrMo Femoral Component is manufactured by Ignite Orthomotion.

What is the FDA product code for Achieve Partial Knee System - Porous Coated CoCrMo Femoral Component?

The FDA product code for Achieve Partial Knee System - Porous Coated CoCrMo Femoral Component is NJD.

Related Clinical Trials

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Related PubMed Literature

PMID: 40258332 Chronic expanding hematoma following Gamma Knife irradiation for primary central nervous system lymphoma: illustrative case. Journal of neurosurgery. Case lessons (2025) PMID: 40179642 Bionic menisci with integrated material-structure-functionality for gouty arthritis. Colloids and surfaces. B, Biointerfaces (2025)

Other Devices by Ignite Orthomotion

K242307ACHIEVE Partial Knee System

Related Devices (Code: NJD)

K190439Engage™ Partial Knee SystemEngage Uni, LLC K222653JOURNEY II UK™ and ENGAGE™ Cementless Partial Knee SystemSmith+Nephew, Inc. K242307ACHIEVE Partial Knee SystemIgnite Orthomotion

Official Source

View on FDA Database →

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

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