FDA.reportPublic FDA data

Shoulder Innovations Humeral Short Stem System

Primary DI
B1132N1HI000010
Brand
Shoulder Innovations Humeral Short Stem System
Company
Shoulder Innovations, Inc.
Model
Humeral Head Trial Insert
Catalog number
2N1HI00001
Device description
Shoulder Innovations - Total Shoulder System. Instrument. Humeral Head Trial Insert Assembly (STB).
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
false
Single use
false

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
B1132N1HI000010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic prosthesis implantation positioning instrument, reusableA hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments [e.g., drill sleeves and guide wires (Kirschner wires), patella saw guide]. It may be used for the following applications: 1) to hold/align/fix/guide other instruments, prostheses, or prosthesis components; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface (non-adaptive) between prosthesis components. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
616-294-1026xxx@xx.xx

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
B1132N2HN140380Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.KWS2026-10-23
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.KWS2026-10-23
B1132N2HN150440Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.KWT2026-10-23
B1132N2HN150440Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.HSD2026-10-23
B1132N2HN150440Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.MBF2026-10-23
B1132N2HN150480Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.MBF2026-10-23
B1132N2HN150480Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.HSD2026-10-23
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
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