FDA.reportPublic FDA data

SOLAR

Primary DI
07613327137682
Brand
SOLAR
Company
Howmedica Osteonics Corp.
Model
5081-4500
Catalog number
5081-4500
Device description
Shoulder Bipolar Modular Head
Published
2015-09-24
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

Product Codes#

Code, Name table
CodeName
MJTPROSTHESIS, SHOULDER, HUMERAL (BIPOLAR HEMI-SHOULDER) METAL/POLYMER, CEMENTED OR UNCEMENTED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MJTProsthesis, Shoulder, Humeral (Bipolar Hemi-Shoulder) Metal/Polymer, Cemented Or UncementedUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K990712000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K990712000OSTEONICS SOLAR SHOULDER BIPOLAR SYSTEMHowmedica Osteonics Corp.1999-07-20MJT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613327137682PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327137682076133271376827613327137682

GMDN Terms#

Term, Definition table
TermDefinition
Total shoulder prosthesisA sterile implantable artificial substitute for a shoulder joint designed to replace both articulating surfaces of the damaged (e.g., fractured) and/or degenerative (e.g., arthritic) joint. It includes glenoid and humeral (head and stem) components typically with parts made of metal and polyethylene (PE). 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
Lumen/Inner Diameter22Millimeter
Outer Diameter45Millimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
058311945
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327259797INSTRUMENT1100-2800R1100-2800R2016-09-24
07613327138078SOLAR5351-41085351-41082015-09-24
04546540167415EXETER0942-2-1100942-2-1102015-09-24
04546540167422EXETER0942-2-1120942-2-1122015-09-24
04546540167439EXETER0942-2-1140942-2-1142015-09-24
04546540167446EXETER0942-2-1160942-2-1162015-09-24
04546540167453EXETER0942-2-1180942-2-1182015-09-24
04546540167460EXETER0942-2-1200942-2-1202015-09-24
07613327245158INSTRUMENT6543-4-8186543-4-8182017-11-13
07613327660180Instrument5533-T-409-R5533-T-409-R2026-02-27
07613327648386Instrument5533-T-812-R5533-T-812-R2026-02-26
07613327648393Instrument5533-T-811-L5533-T-811-L2026-02-26
07613327648409Instrument5533-T-812-L5533-T-812-L2026-02-26
07613327648416Instrument5533-T-810-R5533-T-810-R2026-02-26
07613327648423Instrument5533-T-816-L5533-T-816-L2026-02-26
07613327648430Instrument5533-T-809-L5533-T-809-L2026-02-26
07613327648447Instrument5533-T-814-R5533-T-814-R2026-02-26
07613327648454Instrument5533-T-809-R5533-T-809-R2026-02-26
07613327648461Instrument5533-T-810-L5533-T-810-L2026-02-26
07613327648478Instrument5533-T-811-R5533-T-811-R2026-02-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00880304001619BI-ANGULAR / BI-POLAR SHOULDERBiomet Orthopedics, LLCMJT2015-10-24
00880304002388BIO-MODULAR / BI-POLAR SHOULDERBiomet Orthopedics, LLCMJT2015-10-24
00880304002722BI-ANGULAR / BI-POLAR SHOULDERBiomet Orthopedics, LLCMJT2015-10-24
00880304003477BI-ANGULAR / BI-POLAR SHOULDERBiomet Orthopedics, LLCMJT2015-10-24
00880304003958BIO-MODULAR / BI-POLAR SHOULDERBiomet Orthopedics, LLCMJT2015-10-24
00880304007802BIO-MODULAR / BI-POLAR SHOULDERBiomet Orthopedics, LLCMJT2015-10-24
00880304212398BIO-MODULAR / BI-POLAR SHOULDERBiomet Orthopedics, LLCMJT2015-10-24
00880304212411BIO-MODULAR / BI-POLAR SHOULDERBiomet Orthopedics, LLCMJT2015-10-24
07613327137699SOLARHowmedica Osteonics Corp.MJT2015-09-24
07613327137712SOLARHowmedica Osteonics Corp.MJT2015-09-24
07613327137729SOLARHowmedica Osteonics Corp.MJT2015-09-24
07613327137767SOLARHowmedica Osteonics Corp.MJT2015-09-24
07613327137774SOLARHowmedica Osteonics Corp.MJT2015-09-24
07613327137897SOLARHowmedica Osteonics Corp.MJT2015-09-24
00814193025449B-P TOTAL SHOULDER SYSTEM ENDOTEC, INC.MJT2015-09-17
00814193025456B-P TOTAL SHOULDER SYSTEM ENDOTEC, INC.MJT2015-09-17
00814193025463B-P TOTAL SHOULDER SYSTEM ENDOTEC, INC.MJT2015-09-17
00814193025470B-P TOTAL SHOULDER SYSTEMENDOTEC, INC.MJT2015-09-17
00814193025531B-P TOTAL SHOULDER SYSTEM ENDOTEC, INC.MJT2015-09-17
00814193025548B-P TOTAL SHOULDER SYSTEM ENDOTEC, INC.MJT2015-09-17
00814193025555B-P TOTAL SHOULDER SYSTEM ENDOTEC, INC.MJT2015-09-17
00814193025562B-P TOTAL SHOULDER SYSTEM ENDOTEC, INC.MJT2015-09-17