Home GUDID B1132L2HB285100 Shoulder Innovations InSet FxR 185 Humeral Stem Trial
Primary DI B1132L2HB285100
Brand Shoulder Innovations InSet FxR 185 Humeral Stem Trial
Company Shoulder Innovations, Inc.
Model 10mmX185 Humeral Stem Trial
Catalog number 2L2HB28510
Device description Shoulder Innovations - InSet FxR 185 Humeral Stem Trial - 10mm
Published 2025-12-12
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented MBX Stimulator, Thalamic, Epilepsy, Implanted PHX Shoulder Prosthesis, Reverse Configuration
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic 2 KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic 2 KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented Orthopedic 2 MBX Stimulator, Thalamic, Epilepsy, Implanted Unknown 3 PHX Shoulder Prosthesis, Reverse Configuration Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status B1132L2HB285100 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Orthopaedic prosthesis implantation positioning instrument, reusable A 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
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 DI Brand Model Catalog Published B1132A2HI000100 Shoulder Innovations InSet 95 Humeral Stem Low Profile Lever Lock Broach Handle 2A2HI00010 2026-05-28 B1130S1GK000030 Shoulder Innovations InSet 70 Humeral Stem K-Wire, 2.4mm x 90mm 0S1GK00003 2025-09-18 B1130S1GK000020 Shoulder Innovations Humeral Short Stem System K-Wire Guide 0S1GK00002 2023-11-28 B1132N1HG000000 Shoulder Innovations Humeral Short Stem System K-Wire Guide 2N1HG00000 2023-10-03 B1132N1IA000010 Shoulder Innovations Humeral Short Stem System K-Wire 1.6mm 2N1IA00001 2023-10-03 B1130S1GK00020 SHOULDER INNOVATIONS TSA SYSTEM K WIRE 0S1GK0002 2018-06-30 B1132G1HB300010 Shoulder Innovations Humeral Stemless System Stemless Broach - Minus 2G1HB30001 2026-05-04 B1132G1HB300020 Shoulder Innovations Humeral Stemless System Stemless Broach - Standard 2G1HB30002 2026-05-04 B1132R1NET20360 Shoulder Innovations Inset Reverse Total Shoulder N22 Eccentric EZ Glenosphere - 36mm Diameter x 2mm 2R1NET2036 2026-01-19 B1132R1NET30390 Shoulder Innovations Inset Reverse Total Shoulder N22 Eccentric EZ Glenosphere - 39mm Diameter x 3mm 2R1NET3039 2026-01-19 B1132R1NET40420 Shoulder Innovations Inset Reverse Total Shoulder N22 Eccentric EZ Glenosphere - 42mm Diameter x 4mm 2R1NET4042 2026-01-19 B1132R1NLT03330 Shoulder Innovations Inset Reverse Total Shoulder N22 Lateralized EZ Glenosphere - 33mm Diameter x 0 2R1NLT0333 2026-01-19 B1132R1NLT03360 Shoulder Innovations Inset Reverse Total Shoulder N22 Lateralized EZ Glenosphere - 36mm Diameter x 0 2R1NLT0336 2026-01-19 B1132R1NLT03390 Shoulder Innovations Inset Reverse Total Shoulder N22 Lateralized EZ Glenosphere - 39mm Diameter x 0 2R1NLT0339 2026-01-19 B1132R1NLT03420 Shoulder Innovations Inset Reverse Total Shoulder N22 Lateralized EZ Glenosphere - 42mm Diameter x 0 2R1NLT0342 2026-01-19 B1132R1NLT06330 Shoulder Innovations Inset Reverse Total Shoulder N22 Lateralized EZ Glenosphere - 33mm Diameter x 0 2R1NLT0633 2026-01-19 B1132R1NLT06360 Shoulder Innovations Inset Reverse Total Shoulder N22 Lateralized EZ Glenosphere - 36mm Diameter x 0 2R1NLT0636 2026-01-19 B1132R1NLT06390 Shoulder Innovations Inset Reverse Total Shoulder N22 Lateralized EZ Glenosphere - 39mm Diameter x 0 2R1NLT0639 2026-01-19 B1132R1NLT06420 Shoulder Innovations Inset Reverse Total Shoulder N22 Lateralized EZ Glenosphere - 42mm Diameter x 0 2R1NLT0642 2026-01-19 B1132R1NST00330 Shoulder Innovations Inset Reverse Total Shoulder N22 Standard EZ Glenosphere - 33mm Diameter x 0mm 2R1NST0033 2026-01-19
Other Devices Sharing Product Codes# 
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