FDA.reportPublic FDA data

WaveKahuna™

Primary DI
M528PWR21005W0
Brand
WaveKahuna™
Company
ARTHROSURFACE INCORPORATED
Model
PWR2-1005-W
Catalog number
PWR2-1005-W
Device description
Femoral Component, Right, 10.0mm Offset, Kahuna, CE
Published
2020-03-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KRRProsthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KRRProsthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/PolymerOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K181280000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K181280000Patello-Femoral Wave (Kahuna) Arthroplasty SystemArthrosurface, Inc.2018-06-14KRR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M528PWR21005W0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Partial-resurfacing knee femur prosthesisA sterile implantable device, in the form of a small plug and stem, designed to treat focal lesions of the articular surface of the distal femur by excision of the lesion and uncemented fixation of the device in the surgically-prepared defect, with retention of the surrounding healthy articular cartilage. It is made of metal, may have a synthetic polymer articulating surface, and may be coated with a material intended to improve fixation and stability by promoting bone ingrowth. It is available in a range of sizes for treatment of different size lesions. Disposable devices associated with implantation may be included.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
508-520-3003contact@arthrosurface.com

Regulatory Flags#

DUNS number
144666109
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M5288RB42310A0RevoMotion 8RB4-2310-A2026-05-21
M5288RG032ECA0RevoMotion 8RG0-32EC-A2026-05-21
M5288RG03600A0RevoMotion 8RG0-3600-A2026-05-21
M5288RG036ECA0RevoMotion 8RG0-36EC-A2026-05-21
M5288RG04000A0RevoMotion 8RG0-4000-A2026-05-21
M5288RG040ECA0RevoMotion 8RG0-40EC-A2026-05-21
M5288RG23200A0RevoMotion 8RG2-3200-A2026-05-21
M5288RG232ECA0RevoMotion 8RG2-32EC-A2026-05-21
M5288RG23600A0RevoMotion 8RG2-3600-A2026-05-21
M5288RG236ECA0RevoMotion 8RG2-36EC-A2026-05-21
M5288RG24000A0RevoMotion 8RG2-4000-A2026-05-21
M5288RG240ECA0RevoMotion 8RG2-40EC-A2026-05-21
M5288RG43200A0RevoMotion 3RG4-3200-A2026-05-21
M5288RG43600A0RevoMotion 8RG4-3600-A2026-05-21
M5288RG44000A0RevoMotion 8RG4-4000-A2026-05-21
M5288RM20600A0RevoMotion 8RM2-0600-A2026-05-21
M5288RM20800A0RevoMotion 8RM2-0800-A2026-05-21
M5288RM21000A0RevoMotion 8RM2-1000-A2026-05-21
M5288RM21200A0RevoMotion 8RM2-1200-A2026-05-21
M5288RM21400A0RevoMotion 8RM2-1400-A2026-05-21

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Primary DI, Brand, Company table
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