FDA.reportPublic FDA data

Shoulder Innovations Total Shoulder System

Primary DI
B1132N2HN150480
Brand
Shoulder Innovations Total Shoulder System
Company
Shoulder Innovations, Inc.
Model
15mm x 48mm
Catalog number
2N2HN15048
Device description
Shoulder Innovations - Total Shoulder System - N22 Offset Humeral Head. 15mm Height x 48mm Diameter R30mm Articulation.
Published
2026-10-23
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
HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
KWTProsthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
MBFProsthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented

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
MBFProsthesis, Shoulder, Semi-Constrained, Metal/Polymer, UncementedOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B1132N2HN150480PrimaryHIBCC0

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.

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
false

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
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
B1132N2HN200480Shoulder Innovations Total Shoulder System20mm x 48mm2N2HN200482026-10-23

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.HSD2026-10-23
B1132N1HI000010Shoulder Innovations Humeral Short Stem SystemShoulder Innovations, Inc.MBF2026-10-23
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
B1132N2HN140380Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.HSD2026-10-23
B1132N2HN140380Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.MBF2026-10-23
B1132N2HN150400Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.KWS2026-10-23
B1132N2HN150400Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.KWT2026-10-23
B1132N2HN150400Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.HSD2026-10-23
B1132N2HN150400Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.MBF2026-10-23
B1132N2HN150440Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.MBF2026-10-23
B1132N2HN150440Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.HSD2026-10-23
B1132N2HN150440Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.KWS2026-10-23
B1132N2HN150440Shoulder 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
B1132N2HN150520Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.HSD2026-10-23
B1132N2HN150520Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.MBF2026-10-23
B1132N2HN160380Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.HSD2026-10-23
B1132N2HN160380Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.MBF2026-10-23
B1132N2HN160380Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.KWT2026-10-23
B1132N2HN160380Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.KWS2026-10-23
B1132N2HN160420Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.KWS2026-10-23
B1132N2HN160420Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.KWT2026-10-23
B1132N2HN160420Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.HSD2026-10-23
B1132N2HN160420Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.MBF2026-10-23
B1132N2HN170400Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.KWS2026-10-23
B1132N2HN170400Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.KWT2026-10-23