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FDA 510(k)

Patello-Femoral Wave (Kahuna) Arthroplasty System

K-Number: K181280 · 2018-06-14

ApplicantArthrosurface, Inc.
Decision Date2018-06-14
Product CodeKRR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Patello-Femoral Wave (Kahuna) Arthroplasty System is a medical device manufactured by Arthrosurface, Inc.. It received FDA 510(k) clearance on 2018-06-14 under approval number K181280. 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 Patello-Femoral Wave (Kahuna) Arthroplasty System?

Patello-Femoral Wave (Kahuna) Arthroplasty System is a medical device that received FDA 510(k) clearance on 2018-06-14. It is manufactured by Arthrosurface, Inc.. The 510(k) number is K181280.

When was Patello-Femoral Wave (Kahuna) Arthroplasty System approved by the FDA?

Patello-Femoral Wave (Kahuna) Arthroplasty System received FDA 510(k) clearance on 2018-06-14, under approval number K181280.

What company makes Patello-Femoral Wave (Kahuna) Arthroplasty System?

Patello-Femoral Wave (Kahuna) Arthroplasty System is manufactured by Arthrosurface, Inc..

What is the FDA product code for Patello-Femoral Wave (Kahuna) Arthroplasty System?

The FDA product code for Patello-Femoral Wave (Kahuna) 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 NCT03153449 ATTUNE® Revision- Complex Primary in Total Knee Arthroplasty Population 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

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 Arthrosurface, Inc.

K161539Arthrosurface Bone Screws K152454HemiCAP MTP Resurfacing Hemi-Arthroplasty System K172383Arthrosurface Bone Screws K170440KISSloc Suture System K170350ToeMATE® Hammertoe Correction System K162391AlignMATE™ Lapidus Arthrodesis System

View all 11 devices →

Related Devices (Code: KRR)

K160461Arthrex iBalance BiCompartmental Arthroplasty SystemArthrex, 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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