FDA.reportPublic FDA data

Shoulder Innovations InSet GO

Primary DI
B1132N2GI228000
Brand
Shoulder Innovations InSet GO
Company
Shoulder Innovations, Inc.
Model
22 mm x 8mm
Catalog number
2N2GI22800
Device description
Shoulder Innovations InSet GO Glenoid Implant, Circular In Line Peg, 22mm x 8mm, UHMWPE
Published
2026-09-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
KWTProsthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer CementedOrthopedic2
KWTProsthesis, Shoulder, Non-Constrained, Metal/Polymer CementedOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B1132N2GI228000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Shoulder glenoid fossa prosthesis, prefabricatedAn implantable, prefabricated component of a total shoulder prosthesis (glenoid component) designed to replace or repair the glenoid fossa; it is not a custom-made device. It is cup-like in shape and typically made of polyethylene (PE), but may be made of metal or a combination of PE and metal; it may include fixation devices (e.g., screws) for attachment to the scapula.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
616.294.1026info@shoulderinnovations.com

Regulatory Flags#

DUNS number
080404519
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B1132N1HI000010Shoulder Innovations Humeral Short Stem SystemHumeral Head Trial Insert2N1HI000012026-10-23
B1132N2HN140380Shoulder Innovations Total Shoulder System14mm x 38mm2N2HN140382026-10-23
B1132N2HN150400Shoulder Innovations Total Shoulder System15mm x 40mm2N2HN150402026-10-23
B1132N2HN150440Shoulder Innovations Total Shoulder System15mm x 44mm2N2HN150442026-10-23
B1132N2HN150480Shoulder Innovations Total Shoulder System15mm x 48mm2N2HN150482026-10-23
B1132N2HN150520Shoulder Innovations Total Shoulder System15mm x 52mm2N2HN150522026-10-23
B1132N2HN160380Shoulder Innovations Total Shoulder System16mm x 38mm2N2HN160382026-10-23
B1132N2HN160420Shoulder Innovations Total Shoulder System16mm x 42mm2N2HN160422026-10-23
B1132N2HN170400Shoulder Innovations Total Shoulder System17mm x 40mm2N2HN170402026-10-23
B1132N2HN170440Shoulder Innovations Total Shoulder System17mm x 44mm2N2HN170442026-10-23
B1132N2HN180400Shoulder Innovations Total Shoulder System18mm x 40mm2N2HN180402026-10-23
B1132N2HN180420Shoulder Innovations Total Shoulder System18mm x 42mm2N2HN180422026-10-23
B1132N2HN180440Shoulder Innovations Total Shoulder System18mm x 44mm2N2HN180442026-10-23
B1132N2HN180460Shoulder Innovations Total Shoulder System18mm x 46mm2N2HN180462026-10-23
B1132N2HN180480Shoulder Innovations Total Shoulder System18mm x 48mm2N2HN180482026-10-23
B1132N2HN180520Shoulder Innovations Total Shoulder System18mm x 52mm2N2HN180522026-10-23
B1132N2HN180560Shoulder Innovations Total Shoulder System18mm x 56mm2N2HN180562026-10-23
B1132N2HN190440Shoulder Innovations Total Shoulder System19mm x 44mm2N2HN190442026-10-23
B1132N2HN190500Shoulder Innovations Total Shoulder System19mm x 50mm2N2HN190502026-10-23
B1132N2HN200460Shoulder Innovations Total Shoulder System20mm x 46mm2N2HN200462026-10-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B1132N1HI000010Shoulder Innovations Humeral Short Stem SystemShoulder Innovations, Inc.KWT2026-10-23
B1132N1HI000010Shoulder Innovations Humeral Short Stem SystemShoulder Innovations, Inc.KWS2026-10-23
B1132N2HN140380Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.KWS2026-10-23
B1132N2HN140380Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.KWT2026-10-23
B1132N2HN150400Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.KWS2026-10-23
B1132N2HN150400Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.KWT2026-10-23
B1132N2HN150440Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.KWS2026-10-23
B1132N2HN150440Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.KWT2026-10-23
B1132N2HN150480Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.KWS2026-10-23
B1132N2HN150480Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.KWT2026-10-23
B1132N2HN150520Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.KWS2026-10-23
B1132N2HN150520Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.KWT2026-10-23
B1132N2HN160380Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.KWS2026-10-23
B1132N2HN160380Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.KWT2026-10-23
B1132N2HN160420Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.KWT2026-10-23
B1132N2HN160420Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.KWS2026-10-23
B1132N2HN170400Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.KWS2026-10-23
B1132N2HN170400Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.KWT2026-10-23
B1132N2HN170440Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.KWS2026-10-23
B1132N2HN170440Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.KWT2026-10-23
B1132N2HN180400Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.KWS2026-10-23
B1132N2HN180400Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.KWT2026-10-23
B1132N2HN180420Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.KWS2026-10-23
B1132N2HN180420Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.KWT2026-10-23
B1132N2HN180440Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.KWS2026-10-23
B1132N2HN180440Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.KWT2026-10-23
B1132N2HN180460Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.KWS2026-10-23
B1132N2HN180460Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.KWT2026-10-23
B1132N2HN180480Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.KWS2026-10-23
B1132N2HN180480Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.KWT2026-10-23