FDA.reportPublic FDA data

Maestro™ Total Wrist

Primary DI
00887868239861
Brand
Maestro™ Total Wrist
Company
Biomet Orthopedics, LLC
Model
180395
Catalog number
180395
Published
2018-03-02
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
JWJPROSTHESIS, WRIST, 3 PART METAL-PLASTIC-METAL ARTICULATION, SEMI-CONSTRAINED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JWJProsthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-ConstrainedOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K080426000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K080426000MAESTRO WRIST FRACTURE IMPLANTBiomet Manufacturing Corp2008-07-29JWJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887868239861PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887868239861008878682398618878682398610887868239861

GMDN Terms#

Term, Definition table
TermDefinition
Total wrist carpus prosthesisA sterile implantable device designed to replace some of the carpal bone complex bearing surfaces as part of a total wrist replacement, typically to treat severe bone fracture or degenerative disease (e.g., arthritis). The device is made of metal [e.g., titanium (Ti), cobalt-chrome (Co-Cr), stainless steel] and is implanted into hand bone distally; it interfaces with a polyethylene (PE) spacer proximally. Fixation devices for implantation (e.g., screws) may be included and implantation may be performed with or without bone cement.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)348-9500customerservice@zimmerbiomet.com

Regulatory Flags#

DUNS number
129278169
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00887868549236MULTI-DIRECTIONAL SCREW1312273081312273082022-11-14
00887868549243MULTI-DIRECTIONAL SCREW1312273091312273092022-11-14
00887868549250MULTI-DIRECTIONAL SCREW1312273101312273102022-11-14
00887868549267MULTI-DIRECTIONAL SCREW1312273111312273112022-11-14
00887868549274MULTI-DIRECTIONAL SCREW1312273121312273122022-11-14
00887868549281MULTI-DIRECTIONAL SCREW1312273131312273132022-11-14
00887868549298MULTI-DIRECTIONAL SCREW1312273141312273142022-11-14
00887868549304MULTI-DIRECTIONAL SCREW1312273151312273152022-11-14
00887868549311MULTI-DIRECTIONAL SCREW1312273161312273162022-11-14
00887868549328MULTI-DIRECTIONAL SCREW1312273181312273182022-11-14
00887868549335MULTI-DIRECTIONAL SCREW1312273201312273202022-11-14
00887868549342MULTI-DIRECTIONAL SCREW1312273221312273222022-11-14
00887868549359MULTI-DIRECTIONAL SCREW1312273241312273242022-11-14
00887868549366MULTI-DIRECTIONAL SCREW1312273261312273262022-11-14
00887868549373MULTI-DIRECTIONAL SCREW1312273281312273282022-11-14
00887868549380MULTI-DIRECTIONAL SCREW1312273301312273302022-11-14
00887868544699SMOOTH PEG1312270081312270082022-09-07
00887868544705SMOOTH PEG1312270091312270092022-09-07
00887868544712SMOOTH PEG1312270101312270102022-09-07
00887868544729SMOOTH PEG1312270111312270112022-09-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00885556854839Freedom Wrist Arthroplasty SystemSmith & Nephew, Inc.JWJ2022-12-22
00885556854846Freedom Wrist Arthroplasty SystemSmith & Nephew, Inc.JWJ2022-12-22
00885556854853Freedom Wrist Arthroplasty SystemSmith & Nephew, Inc.JWJ2022-12-22
00885556855249Freedom Wrist Arthroplasty SystemSmith & Nephew, Inc.JWJ2022-12-22
00885556855256Freedom Wrist Arthroplasty SystemSmith & Nephew, Inc.JWJ2022-12-22
00885556855263Freedom Wrist Arthroplasty SystemSmith & Nephew, Inc.JWJ2022-12-22
00885556855270Freedom Wrist Arthroplasty SystemSmith & Nephew, Inc.JWJ2022-12-22
00885556855287Freedom Wrist Arthroplasty SystemSmith & Nephew, Inc.JWJ2022-12-22
00885556855294Freedom Wrist Arthroplasty SystemSmith & Nephew, Inc.JWJ2022-12-22
00885556855553Freedom Wrist Arthroplasty SystemSmith & Nephew, Inc.JWJ2022-12-22
00885556855560Freedom Wrist Arthroplasty SystemSmith & Nephew, Inc.JWJ2022-12-22
00885556855577Freedom Wrist Arthroplasty SystemSmith & Nephew, Inc.JWJ2022-12-22
00885556855584Freedom Wrist Arthroplasty SystemSmith & Nephew, Inc.JWJ2022-12-22
00885556855591Freedom Wrist Arthroplasty SystemSmith & Nephew, Inc.JWJ2022-12-22
00885556855607Freedom Wrist Arthroplasty SystemSmith & Nephew, Inc.JWJ2022-12-22
00885556855614Freedom Wrist Arthroplasty SystemSmith & Nephew, Inc.JWJ2022-12-22
00885556855621Freedom Wrist Arthroplasty SystemSmith & Nephew, Inc.JWJ2022-12-22
00885556855638Freedom Wrist Arthroplasty SystemSmith & Nephew, Inc.JWJ2022-12-22
00885556855669Freedom Wrist Arthroplasty SystemSmith & Nephew, Inc.JWJ2022-12-22
00885556855676Freedom Wrist Arthroplasty SystemSmith & Nephew, Inc.JWJ2022-12-22
00885556855683Freedom Wrist Arthroplasty SystemSmith & Nephew, Inc.JWJ2022-12-22
00885556855690Freedom Wrist Arthroplasty SystemSmith & Nephew, Inc.JWJ2022-12-22
00885556855706Freedom Wrist Arthroplasty SystemSmith & Nephew, Inc.JWJ2022-12-22
00885556855713Freedom Wrist Arthroplasty SystemSmith & Nephew, Inc.JWJ2022-12-22
00885556855720Freedom Wrist Arthroplasty SystemSmith & Nephew, Inc.JWJ2022-12-22
00885556855737Freedom Wrist Arthroplasty SystemSmith & Nephew, Inc.JWJ2022-12-22
00885556855744Freedom Wrist Arthroplasty SystemSmith & Nephew, Inc.JWJ2022-12-22
00885556855751Freedom Wrist Arthroplasty SystemSmith & Nephew, Inc.JWJ2022-12-22
00885556855768Freedom Wrist Arthroplasty SystemSmith & Nephew, Inc.JWJ2022-12-22
00885556855775Freedom Wrist Arthroplasty SystemSmith & Nephew, Inc.JWJ2022-12-22