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FDA 510(k)

REMEDY Stemmed Knee Spacer System with All-Poly Tibial Component

K-Number: K242377 · 2024-10-02

ApplicantOsteoremedies, LLC
Decision Date2024-10-02
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

REMEDY Stemmed Knee Spacer System with All-Poly Tibial Component is a medical device manufactured by Osteoremedies, LLC. It received FDA 510(k) clearance on 2024-10-02 under approval number K242377. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REMEDY Stemmed Knee Spacer System with All-Poly Tibial Component?

REMEDY Stemmed Knee Spacer System with All-Poly Tibial Component is a medical device that received FDA 510(k) clearance on 2024-10-02. It is manufactured by Osteoremedies, LLC. The 510(k) number is K242377.

When was REMEDY Stemmed Knee Spacer System with All-Poly Tibial Component approved by the FDA?

REMEDY Stemmed Knee Spacer System with All-Poly Tibial Component received FDA 510(k) clearance on 2024-10-02, under approval number K242377.

What company makes REMEDY Stemmed Knee Spacer System with All-Poly Tibial Component?

REMEDY Stemmed Knee Spacer System with All-Poly Tibial Component is manufactured by Osteoremedies, LLC.

What is the FDA product code for REMEDY Stemmed Knee Spacer System with All-Poly Tibial Component?

The FDA product code for REMEDY Stemmed Knee Spacer System with All-Poly Tibial Component is JWH.

Related Clinical Trials

NCT06019832 Analysis of Varus Collapse in Obese Patients With Stem and Non-Stem Tibial Components Following Primary Total Knee Arthroplasty ACTIVE_NOT_RECRUITING NCT06655844 Sana Device for Post-Treatment Lyme Disease Syndrome Chronic Pain RECRUITING NCT07456865 Post Approval Effectiveness and Durability Evaluation of the Altaviva™ Tibial Device RECRUITING NCT07147296 ARC-IM System to Manage Symptomatic Blood Pressure Instability Secondary to Chronic Spinal Cord Injury RECRUITING NCT07409363 Non-invasive Vagus Nerve Stimulation for Chronic Musculoskeletal Pain NOT_YET_RECRUITING NCT03153449 ATTUNE® Revision- Complex Primary in Total Knee Arthroplasty Population ACTIVE_NOT_RECRUITING

Related PubMed Literature

PMID: 40407411 A data augmentation approach for an automatic speech recognition system using laser Doppler vibrometer technology. JASA express letters (2025)

Other Devices by Osteoremedies, LLC

K172906REMEDY PLUS Hip Spacer, UNITE PLUS Bone Cement K173967Remedy Acetabular Cup K191981REMEDY Acetabular Cup K183017Remedy Femoral Component 84mm, Remedy Stemmed Knee Spacer K192995OsteoRemedies Hip Spacer System K231556SPECTRUM® GV Bone Cement

View all 10 devices →

Related Devices (Code: JWH)

K160515PS2 Knee SystemConsensus Orthopedics, Inc. K160771Destiknee Total Knee SystemMeril Healthcare Private Limited K160157LOSPA Modular Knee SystemCorentec Co., Ltd. K162273Materialise TKA Guide SystemMaterialise NV K162422Klassic Knee SystemTotal Joint Orthopedics, Inc. K161945EXPRT Revision Knee Femoral Augment(5mm), EXPRT Revision Knee Stem Extension (40mm)Encore Medical L.P.

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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