HemiCAPITATETM

Primary DI
M5288W152223A0
Brand
HemiCAPITATETM
Company
ARTHROSURFACE INCORPORATED
Model
8W15-2223-A
Catalog number
8W15-2223-A
Device description
15mm Capitate Component, 22mm x 23mm, Wrist
Published
2016-07-14
Public version status
Update
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
KWNProsthesis, Wrist, Carpal Lunate

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWNProsthesis, Wrist, Carpal LunateOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K141920000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141920000Wrist Hemiarthroplasty SystemArthrosurface, Inc.2014-12-23KWN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M5288W152223A0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Carpal lunate prosthesisA sterile implantable device designed to replace the lunate bone in the proximal carpal row of the wrist typically in the presence of avascular necrosis, localized osteoarthritic changes, or longstanding dislocations. It is typically a one-piece device, made of one or several materials (e.g., carbon, graphite, metal), that may reflect the shape of the native bone. Short-term fixation is typically performed with sutures.

Contacts#

Phone, Email table
PhoneEmail
508-520-3003gbutterfield@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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00885556858721PyroCarbon LunateSmith & Nephew, Inc.KWN2023-02-10
00885556858738PyroCarbon LunateSmith & Nephew, Inc.KWN2023-02-10
00885556858745PyroCarbon LunateSmith & Nephew, Inc.KWN2023-02-10
00885556858752PyroCarbon LunateSmith & Nephew, Inc.KWN2023-02-10
00885556858769PyroCarbon LunateSmith & Nephew, Inc.KWN2023-02-10
00885556858820PyroCarbon LunateSmith & Nephew, Inc.KWN2023-02-10
00885556858837PyroCarbon LunateSmith & Nephew, Inc.KWN2023-02-10
00885556858844PyroCarbon LunateSmith & Nephew, Inc.KWN2023-02-10
00885556858851PyroCarbon LunateSmith & Nephew, Inc.KWN2023-02-10
00885556858868PyroCarbon LunateSmith & Nephew, Inc.KWN2023-02-10
M5288W122217W0WristMotion® Wrist Hemiarthroplasty SystemARTHROSURFACE INCORPORATEDKWN2020-03-31
M5288W123517W0WristMotion® Wrist Hemiarthroplasty SystemARTHROSURFACE INCORPORATEDKWN2020-03-31
M5288W152217W0WristMotion® Wrist Hemiarthroplasty SystemARTHROSURFACE INCORPORATEDKWN2020-03-31
M5288W152223W0WristMotion® Wrist Hemiarthroplasty SystemARTHROSURFACE INCORPORATEDKWN2020-03-31
M5288W153517W0WristMotion® Wrist Hemiarthroplasty SystemARTHROSURFACE INCORPORATEDKWN2020-03-31
M5288W153523W0WristMotion® Wrist Hemiarthroplasty SystemARTHROSURFACE INCORPORATEDKWN2020-03-31
M5288W950016W0WristMotion® Wrist Hemiarthroplasty SystemARTHROSURFACE INCORPORATEDKWN2020-03-31
M5288W122217A0HemiCAPITATETMARTHROSURFACE INCORPORATEDKWN2018-04-16
00887868239830Maestro™ Total WristBiomet Orthopedics, LLCKWN2018-03-02
00887868239847Maestro™ Total WristBiomet Orthopedics, LLCKWN2018-03-02
00887868239854Maestro™ Total WristBiomet Orthopedics, LLCKWN2018-03-02
10381780116240Ascension® PyroCarbon LunateAscension Orthopedics, Inc.KWN2017-10-09
10381780116257Ascension® PyroCarbon LunateAscension Orthopedics, Inc.KWN2017-10-09
10381780116264Ascension® PyroCarbon LunateAscension Orthopedics, Inc.KWN2017-10-09
10381780116271Ascension® PyroCarbon LunateAscension Orthopedics, Inc.KWN2017-10-09
10381780116288Ascension® PyroCarbon LunateAscension Orthopedics, Inc.KWN2017-10-09
10381780235040Integra®Ascension Orthopedics, Inc.KWN2016-08-15
10381780236795Integra®Ascension Orthopedics, Inc.KWN2016-08-15
10381780236801Integra®Ascension Orthopedics, Inc.KWN2016-08-15
10381780236818Integra®Ascension Orthopedics, Inc.KWN2016-08-15