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FDA 510(k)

BKS Revision System

K-Number: K242984 · 2024-10-25

ApplicantOrtho Development Corp.
Decision Date2024-10-25
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BKS Revision System is a medical device manufactured by Ortho Development Corp.. It received FDA 510(k) clearance on 2024-10-25 under approval number K242984. 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 BKS Revision System?

BKS Revision System is a medical device that received FDA 510(k) clearance on 2024-10-25. It is manufactured by Ortho Development Corp.. The 510(k) number is K242984.

When was BKS Revision System approved by the FDA?

BKS Revision System received FDA 510(k) clearance on 2024-10-25, under approval number K242984.

What company makes BKS Revision System?

BKS Revision System is manufactured by Ortho Development Corp..

What is the FDA product code for BKS Revision System?

The FDA product code for BKS Revision System is JWH.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT03153475 ATTUNE Revision System in the Revision Total Knee Arthroplasty Population ACTIVE_NOT_RECRUITING NCT04984291 Zimmer Biomet Shoulder Arthroplasty PMCF RECRUITING NCT01480440 Outcomes Study of the Trabecular Metal (TM) Reverse Shoulder System ACTIVE_NOT_RECRUITING

Other Devices by Ortho Development Corp.

K242833Legend® Acetabular Shell K233758Trivicta™ Hip Stem K253161Balanced Knee System TriMax Porous Femoral Components K251052Trivicta® Hip Stem

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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