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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 the device name listed in this FDA 510(k) record. The listed applicant is Arthrosurface, Inc.. It received FDA 510(k) clearance on 2018-06-14 under 510(k) 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. The listed applicant is Arthrosurface, Inc.. The 510(k) number is K181280.

When did Patello-Femoral Wave (Kahuna) Arthroplasty System receive FDA 510(k) clearance?

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

Who is the listed applicant for Patello-Femoral Wave (Kahuna) Arthroplasty System?

The FDA 510(k) record lists Arthrosurface, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Arthrosurface, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K203375OVOMotion Reverse Shoulder Arthroplasty SystemK200718Arthrosurface WristMotion Total Wrist Arthroplasty SystemK190261BOSS Toe Fixation SystemK173964OVOMotion Shoulder Arthroplasty SystemK172383Arthrosurface Bone ScrewsK170440KISSloc Suture System

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Related Devices (Code: KRR)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K231253Overture Orthopaedics Patellofemoral SystemOverture Resurfacing, Inc.K221048Episealer Patellofemoral SystemEpisurf Medical, Inc.K211303Avon Patello-femoral Joint ProsthesisHowmedica Osteonics Corp., Dba Stryker OrthopaedicsK200122MOTO PFJ SystemMedacta International S.A.K160461Arthrex iBalance BiCompartmental Arthroplasty SystemArthrex, 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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