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FDA 510(k)

Arthrex iBalance BiCompartmental Arthroplasty System

K-Number: K160461 · 2016-04-12

ApplicantArthrex, Inc.
Decision Date2016-04-12
Product CodeKRR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Arthrex iBalance BiCompartmental Arthroplasty System is a medical device manufactured by Arthrex, Inc.. It received FDA 510(k) clearance on 2016-04-12 under approval number K160461. The device is classified under product code KRR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Arthrex iBalance BiCompartmental Arthroplasty System?

Arthrex iBalance BiCompartmental Arthroplasty System is a medical device that received FDA 510(k) clearance on 2016-04-12. It is manufactured by Arthrex, Inc.. The 510(k) number is K160461.

When was Arthrex iBalance BiCompartmental Arthroplasty System approved by the FDA?

Arthrex iBalance BiCompartmental Arthroplasty System received FDA 510(k) clearance on 2016-04-12, under approval number K160461.

What company makes Arthrex iBalance BiCompartmental Arthroplasty System?

Arthrex iBalance BiCompartmental Arthroplasty System is manufactured by Arthrex, Inc..

What is the FDA product code for Arthrex iBalance BiCompartmental Arthroplasty System?

The FDA product code for Arthrex iBalance BiCompartmental Arthroplasty System is KRR.

Related Clinical Trials

NCT07191067 Pivotal Study on the NOVABLOC System for Patients Undergoing Primary Total Knee Arthroplasty RECRUITING NCT04325022 Safety and Effectiveness Study of OR3O™ Dual Mobility System in THA ACTIVE_NOT_RECRUITING NCT03073941 A Multicenter Prospective Randomized Control Study on Persona Total Knee System vs NexGen ACTIVE_NOT_RECRUITING NCT03153475 ATTUNE Revision System in the Revision Total Knee Arthroplasty Population ACTIVE_NOT_RECRUITING NCT07569549 Surgery for Thumb Base Osteoarthritis: Joint Replacement vs. Trapeziectomy NOT_YET_RECRUITING NCT06792539 Evaluate the Safety and Effectiveness of the Polymotion Hip Resurfacing (PHR) System Compared to Total Hip Arthroplasty ACTIVE_NOT_RECRUITING

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)

Other Devices by Arthrex, Inc.

K161060Arthrex iBalance UKA System Vitamin E Tibial Bearing K161782Arthrex Univers Revers Shoulder Prosthesis System K161581Arthrex Synergy RF System K161108Arthrex VaultLock Glenoid K160319FiberTak DR K151527Arthrex Univers Revers CA Heads and Adapters

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Related Devices (Code: KRR)

K181280Patello-Femoral Wave (Kahuna) Arthroplasty SystemArthrosurface, Inc. K200122MOTO PFJ SystemMedacta International S.A. K211303Avon Patello-femoral Joint ProsthesisHowmedica Osteonics Corp., Dba Stryker Orthopaedics K221048Episealer Patellofemoral SystemEpisurf Medical, Inc. K231253Overture Orthopaedics Patellofemoral SystemOverture Resurfacing, Inc.

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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