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FDA 510(k)

Stabil Orthopaedic Solutions Total Knee System

K-Number: K183225 · 2019-02-15

ApplicantStabil Orthopaedic Solutions, LLC
Decision Date2019-02-15
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Stabil Orthopaedic Solutions Total Knee System is a medical device manufactured by Stabil Orthopaedic Solutions, LLC. It received FDA 510(k) clearance on 2019-02-15 under approval number K183225. 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 Stabil Orthopaedic Solutions Total Knee System?

Stabil Orthopaedic Solutions Total Knee System is a medical device that received FDA 510(k) clearance on 2019-02-15. It is manufactured by Stabil Orthopaedic Solutions, LLC. The 510(k) number is K183225.

When was Stabil Orthopaedic Solutions Total Knee System approved by the FDA?

Stabil Orthopaedic Solutions Total Knee System received FDA 510(k) clearance on 2019-02-15, under approval number K183225.

What company makes Stabil Orthopaedic Solutions Total Knee System?

Stabil Orthopaedic Solutions Total Knee System is manufactured by Stabil Orthopaedic Solutions, LLC.

What is the FDA product code for Stabil Orthopaedic Solutions Total Knee System?

The FDA product code for Stabil Orthopaedic Solutions Total Knee System is JWH.

Related Clinical Trials

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Related PubMed Literature

PMID: 42173476 Feasibility of applying the Orthopaedic Data Evaluation Panel (ODEP) shoulder criteria for implants used in a United States-based integrated healthcare system. Journal of shoulder and elbow surgery (2026) PMID: 41966529 Comparison of the AccuPower HIV-1 Quant Kit and Aptima HIV-1 Quant Dx Assay for quantification of HIV-1 plasma viral load. Diagnostic microbiology and infectious disease (2026) PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025) PMID: 41966145 From Registry to Reality: Opportunities to Enhance Post-market Surveillance of High-Risk Medical Devices Comment on "Quality and Utility of European Cardiovascular and Orthopaedic Registries for the Regulatory Evaluation of Medical Device Safety and Performance Across the Implant Lifecycle: A Systematic Review". International journal of health policy and management (2025)

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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