FDA.reportPublic FDA data

Shoulder Innovations InSet GO

Primary DI
B1132N2GI220100
Brand
Shoulder Innovations InSet GO
Company
Shoulder Innovations, Inc.
Model
22 mm x 10°
Catalog number
2N2GI22010
Device description
Shoulder Innovations InSet GO Plus Glenoid Implant, Circular In Line Peg, 22mm x 10°, 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
B1132N2GI220100PrimaryHIBCC0

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
B1132N2GI200050Shoulder Innovations InSet GO20 mm x 5°2N2GI200052026-09-18
B1132N2GI200100Shoulder Innovations InSet GO20 mm x 10°2N2GI200102026-09-18
B1132N2GI206000Shoulder Innovations InSet GO20 mm x 6mm2N2GI206002026-09-18
B1132N2GI208000Shoulder Innovations InSet GO20 mm x 8mm2N2GI208002026-09-18
B1132N2GI220050Shoulder Innovations InSet GO22 mm x 5°2N2GI220052026-09-18
B1132N2GI226000Shoulder Innovations InSet GO22 mm x 6mm2N2GI226002026-09-18
B1132N2GI228000Shoulder Innovations InSet GO22 mm x 8mm2N2GI228002026-09-18
B1132N2GI240050Shoulder Innovations InSet GO24 mm x 5°2N2GI240052026-09-18
B1132N2GI240100Shoulder Innovations InSet GO24 mm x 10°2N2GI240102026-09-18
B1132N2GI246000Shoulder Innovations InSet GO24 mm x 6mm2N2GI246002026-09-18
B1132N2GI248000Shoulder Innovations InSet GO24 mm x 8mm2N2GI248002026-09-18
B1132N2GI270050Shoulder Innovations InSet GO27 mm x 5°2N2GI270052026-09-18
B1132N2GI270100Shoulder Innovations InSet GO27 mm x 10°2N2GI270102026-09-18
B1132N2GI276000Shoulder Innovations InSet GO27 mm x 6mm2N2GI276002026-09-18
B1132N2GI278000Shoulder Innovations InSet GO27 mm x 8mm2N2GI278002026-09-18
B1132A2HI000100Shoulder Innovations InSet 95 Humeral StemLow Profile Lever Lock Broach Handle2A2HI000102026-05-28
B1130S1GK000030Shoulder Innovations InSet 70 Humeral StemK-Wire, 2.4mm x 90mm0S1GK000032025-09-18
B1130S1GK000020Shoulder Innovations Humeral Short Stem SystemK-Wire Guide0S1GK000022023-11-28
B1132N1HG000000Shoulder Innovations Humeral Short Stem SystemK-Wire Guide2N1HG000002023-10-03
B1132N1IA000010Shoulder Innovations Humeral Short Stem SystemK-Wire 1.6mm2N1IA000012023-10-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B1132N2GI200050Shoulder Innovations InSet GOShoulder Innovations, Inc.KWT2026-09-18
B1132N2GI200050Shoulder Innovations InSet GOShoulder Innovations, Inc.KWS2026-09-18
B1132N2GI200100Shoulder Innovations InSet GOShoulder Innovations, Inc.KWT2026-09-18
B1132N2GI200100Shoulder Innovations InSet GOShoulder Innovations, Inc.KWS2026-09-18
B1132N2GI206000Shoulder Innovations InSet GOShoulder Innovations, Inc.KWT2026-09-18
B1132N2GI206000Shoulder Innovations InSet GOShoulder Innovations, Inc.KWS2026-09-18
B1132N2GI208000Shoulder Innovations InSet GOShoulder Innovations, Inc.KWT2026-09-18
B1132N2GI208000Shoulder Innovations InSet GOShoulder Innovations, Inc.KWS2026-09-18
B1132N2GI220050Shoulder Innovations InSet GOShoulder Innovations, Inc.KWS2026-09-18
B1132N2GI220050Shoulder Innovations InSet GOShoulder Innovations, Inc.KWT2026-09-18
B1132N2GI226000Shoulder Innovations InSet GOShoulder Innovations, Inc.KWS2026-09-18
B1132N2GI226000Shoulder Innovations InSet GOShoulder Innovations, Inc.KWT2026-09-18
B1132N2GI228000Shoulder Innovations InSet GOShoulder Innovations, Inc.KWS2026-09-18
B1132N2GI228000Shoulder Innovations InSet GOShoulder Innovations, Inc.KWT2026-09-18
B1132N2GI240050Shoulder Innovations InSet GOShoulder Innovations, Inc.KWT2026-09-18
B1132N2GI240050Shoulder Innovations InSet GOShoulder Innovations, Inc.KWS2026-09-18
B1132N2GI240100Shoulder Innovations InSet GOShoulder Innovations, Inc.KWS2026-09-18
B1132N2GI240100Shoulder Innovations InSet GOShoulder Innovations, Inc.KWT2026-09-18
B1132N2GI246000Shoulder Innovations InSet GOShoulder Innovations, Inc.KWS2026-09-18
B1132N2GI246000Shoulder Innovations InSet GOShoulder Innovations, Inc.KWT2026-09-18
B1132N2GI248000Shoulder Innovations InSet GOShoulder Innovations, Inc.KWT2026-09-18
B1132N2GI248000Shoulder Innovations InSet GOShoulder Innovations, Inc.KWS2026-09-18
B1132N2GI270050Shoulder Innovations InSet GOShoulder Innovations, Inc.KWT2026-09-18
B1132N2GI270050Shoulder Innovations InSet GOShoulder Innovations, Inc.KWS2026-09-18
B1132N2GI270100Shoulder Innovations InSet GOShoulder Innovations, Inc.KWS2026-09-18
B1132N2GI270100Shoulder Innovations InSet GOShoulder Innovations, Inc.KWT2026-09-18
B1132N2GI276000Shoulder Innovations InSet GOShoulder Innovations, Inc.KWS2026-09-18
B1132N2GI276000Shoulder Innovations InSet GOShoulder Innovations, Inc.KWT2026-09-18
B1132N2GI278000Shoulder Innovations InSet GOShoulder Innovations, Inc.KWS2026-09-18
B1132N2GI278000Shoulder Innovations InSet GOShoulder Innovations, Inc.KWT2026-09-18