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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 the device name listed in this FDA 510(k) record. The listed applicant is Ignite Orthomotion. It received FDA 510(k) clearance on 2025-09-02 under 510(k) 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. The listed applicant is Ignite Orthomotion. The 510(k) number is K251975.

When did Achieve Partial Knee System - Porous Coated CoCrMo Femoral Component receive FDA 510(k) clearance?

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

Who is the listed applicant for Achieve Partial Knee System - Porous Coated CoCrMo Femoral Component?

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 - Porous Coated CoCrMo Femoral Component?

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

Related Clinical Trials

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.

NCT03720782Safety and Performance Study of the Legion Porous System in Total Knee ArthroplastyACTIVE_NOT_RECRUITINGNCT03153449ATTUNE® Revision- Complex Primary in Total Knee Arthroplasty PopulationACTIVE_NOT_RECRUITINGNCT03153475ATTUNE Revision System in the Revision Total Knee Arthroplasty PopulationACTIVE_NOT_RECRUITINGNCT06627673MultiCenter IDE Study of the PEEK-OPTIMA™ Femoral Component vs a CoCr Alloy TKA Femoral Component of Similar DesignRECRUITINGNCT07286513Persona SoluTion PPS Femur PMCFENROLLING_BY_INVITATIONNCT076337173-D Printed Resin Composite Versus Milled Resin Composite and Hybrid Ceramic Onlays: 2-Year Clinical Performance, Microtensile Bond Strength, Marginal and Internal AdaptationACTIVE_NOT_RECRUITING

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.

K242307ACHIEVE Partial Knee System

Related Devices (Code: NJD)

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.

K242307ACHIEVE Partial Knee SystemIgnite OrthomotionK222653JOURNEY II UK™ and ENGAGE™ Cementless Partial Knee SystemSmith+Nephew, Inc.K190439Engage™ Partial Knee SystemEngage Uni, LLC

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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