FDA.reportPublic FDA data

Shoulder Innovations InSet 70 Humeral Stem

Primary DI
B1130S1GK000030
Brand
Shoulder Innovations InSet 70 Humeral Stem
Company
Shoulder Innovations, Inc.
Model
K-Wire, 2.4mm x 90mm
Catalog number
0S1GK00003
Device description
Shoulder Innovations - InSet 70 Humeral Stem - Instrument: K-Wire, 2.4mm x 90mm
Published
2025-09-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
B1130S1GK000030PrimaryHIBCC0

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
616-294-1026info@shoulderinnovations.com

Regulatory Flags#

DUNS number
080404519
Device count
1
Lot or batch
true
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.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
B1132N2HN150480Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.KWS2026-10-23
B1132N2HN150480Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.KWT2026-10-23
B1132N2HN150480Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.HSD2026-10-23
B1132N2HN150480Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.MBF2026-10-23
B1132N2HN150520Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.HSD2026-10-23
B1132N2HN150520Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.MBF2026-10-23
B1132N2HN150520Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.KWT2026-10-23
B1132N2HN150520Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.KWS2026-10-23
B1132N2HN160380Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.KWS2026-10-23
B1132N2HN160380Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.KWT2026-10-23
B1132N2HN160380Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.HSD2026-10-23
B1132N2HN160380Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.MBF2026-10-23
B1132N2HN160420Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.KWS2026-10-23
B1132N2HN160420Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.KWT2026-10-23