FDA.reportPublic FDA data

Shoulder Innovations InSet FxR 185

Primary DI
B1132L1S0800030
Brand
Shoulder Innovations InSet FxR 185
Company
Shoulder Innovations, Inc.
Model
8mmX185
Catalog number
2L1S080003
Device description
Shoulder Innovations - InSet FxR 185 - 8mmX185
Published
2025-12-12
Public version status
New
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
HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
KWTProsthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
MBXStimulator, Thalamic, Epilepsy, Implanted
PHXShoulder Prosthesis, Reverse Configuration

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic UncementedOrthopedic2
KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer CementedOrthopedic2
KWTProsthesis, Shoulder, Non-Constrained, Metal/Polymer CementedOrthopedic2
MBXStimulator, Thalamic, Epilepsy, ImplantedUnknown3
PHXShoulder Prosthesis, Reverse ConfigurationOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B1132L1S0800030PrimaryHIBCC0

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.

Sterilization Methods#

Method table
Method
Radiation Sterilization

Contacts#

Phone, Email table
PhoneEmail
616-294-1026info@shoulderinnovations.com

Regulatory Flags#

DUNS number
080404519
Device count
1
Lot or batch
true
Expiration date on label
true
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
B1132N2GI220100Shoulder Innovations InSet GO22 mm x 10°2N2GI220102026-09-18
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840097533919Veritas HemiarthroplastyRestor3d, Inc.HSD2026-09-18
00840097533919Veritas HemiarthroplastyRestor3d, Inc.PHX2026-09-18
00840097533926Veritas HemiarthroplastyRestor3d, Inc.PHX2026-09-18
00840097533926Veritas HemiarthroplastyRestor3d, Inc.HSD2026-09-18
00840097533933Veritas HemiarthroplastyRestor3d, Inc.PHX2026-09-18
00840097533933Veritas HemiarthroplastyRestor3d, Inc.HSD2026-09-18
00840097533940Veritas HemiarthroplastyRestor3d, Inc.PHX2026-09-18
00840097533940Veritas HemiarthroplastyRestor3d, Inc.HSD2026-09-18
00840097533957Veritas HemiarthroplastyRestor3d, Inc.PHX2026-09-18
00840097533957Veritas HemiarthroplastyRestor3d, Inc.HSD2026-09-18
00840097533964Veritas HemiarthroplastyRestor3d, Inc.PHX2026-09-18
00840097533964Veritas HemiarthroplastyRestor3d, Inc.HSD2026-09-18
00840097533971Veritas HemiarthroplastyRestor3d, Inc.PHX2026-09-18
00840097533971Veritas HemiarthroplastyRestor3d, Inc.HSD2026-09-18
00840097533988Veritas HemiarthroplastyRestor3d, Inc.HSD2026-09-18
00840097533988Veritas HemiarthroplastyRestor3d, Inc.PHX2026-09-18
00840097533995Veritas HemiarthroplastyRestor3d, Inc.PHX2026-09-18
00840097533995Veritas HemiarthroplastyRestor3d, Inc.HSD2026-09-18
00840097534008Veritas HemiarthroplastyRestor3d, Inc.PHX2026-09-18
00840097534008Veritas HemiarthroplastyRestor3d, Inc.HSD2026-09-18
00840097534015Veritas HemiarthroplastyRestor3d, Inc.PHX2026-09-18
00840097534015Veritas HemiarthroplastyRestor3d, Inc.HSD2026-09-18
00840097534022Veritas HemiarthroplastyRestor3d, Inc.PHX2026-09-18
00840097534022Veritas HemiarthroplastyRestor3d, Inc.HSD2026-09-18
B1132N2GI200050Shoulder Innovations InSet GOShoulder Innovations, Inc.KWS2026-09-18
B1132N2GI200050Shoulder Innovations InSet GOShoulder Innovations, Inc.KWT2026-09-18
B1132N2GI200100Shoulder Innovations InSet GOShoulder Innovations, Inc.KWS2026-09-18
B1132N2GI200100Shoulder Innovations InSet GOShoulder Innovations, Inc.KWT2026-09-18
B1132N2GI206000Shoulder Innovations InSet GOShoulder Innovations, Inc.KWT2026-09-18
B1132N2GI206000Shoulder Innovations InSet GOShoulder Innovations, Inc.KWS2026-09-18