FDA.reportPublic FDA data

Shoulder Innovations Inset Reverse Total Shoulder

Primary DI
B1132R1NET40420
Brand
Shoulder Innovations Inset Reverse Total Shoulder
Company
Shoulder Innovations, Inc.
Model
N22 Eccentric EZ Glenosphere - 42mm Diameter x 4mm
Catalog number
2R1NET4042
Device description
Shoulder Innovations Inset Reverse Total Shoulder - N22 Eccentric EZ Glenosphere - 42mm Diameter x 4mm Ecc x 0mm Lat
Published
2026-01-19
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
MBFProsthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
PHXShoulder Prosthesis, Reverse Configuration

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MBFProsthesis, Shoulder, Semi-Constrained, Metal/Polymer, UncementedOrthopedic2
PHXShoulder Prosthesis, Reverse ConfigurationOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B1132R1NET40420PrimaryHIBCC0

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
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
B1132N1IA000010Shoulder Innovations Humeral Short Stem SystemK-Wire 1.6mm2N1IA000012023-10-03
B1130S1GK00020SHOULDER INNOVATIONS TSA SYSTEMK WIRE0S1GK00022018-06-30
B1132G1HB300010Shoulder Innovations Humeral Stemless SystemStemless Broach - Minus2G1HB300012026-05-04
B1132G1HB300020Shoulder Innovations Humeral Stemless SystemStemless Broach - Standard2G1HB300022026-05-04
B1132R1NET20360Shoulder Innovations Inset Reverse Total ShoulderN22 Eccentric EZ Glenosphere - 36mm Diameter x 2mm2R1NET20362026-01-19
B1132R1NET30390Shoulder Innovations Inset Reverse Total ShoulderN22 Eccentric EZ Glenosphere - 39mm Diameter x 3mm2R1NET30392026-01-19
B1132R1NLT03330Shoulder Innovations Inset Reverse Total ShoulderN22 Lateralized EZ Glenosphere - 33mm Diameter x 02R1NLT03332026-01-19
B1132R1NLT03360Shoulder Innovations Inset Reverse Total ShoulderN22 Lateralized EZ Glenosphere - 36mm Diameter x 02R1NLT03362026-01-19
B1132R1NLT03390Shoulder Innovations Inset Reverse Total ShoulderN22 Lateralized EZ Glenosphere - 39mm Diameter x 02R1NLT03392026-01-19
B1132R1NLT03420Shoulder Innovations Inset Reverse Total ShoulderN22 Lateralized EZ Glenosphere - 42mm Diameter x 02R1NLT03422026-01-19
B1132R1NLT06330Shoulder Innovations Inset Reverse Total ShoulderN22 Lateralized EZ Glenosphere - 33mm Diameter x 02R1NLT06332026-01-19
B1132R1NLT06360Shoulder Innovations Inset Reverse Total ShoulderN22 Lateralized EZ Glenosphere - 36mm Diameter x 02R1NLT06362026-01-19
B1132R1NLT06390Shoulder Innovations Inset Reverse Total ShoulderN22 Lateralized EZ Glenosphere - 39mm Diameter x 02R1NLT06392026-01-19
B1132R1NLT06420Shoulder Innovations Inset Reverse Total ShoulderN22 Lateralized EZ Glenosphere - 42mm Diameter x 02R1NLT06422026-01-19
B1132R1NST00330Shoulder Innovations Inset Reverse Total ShoulderN22 Standard EZ Glenosphere - 33mm Diameter x 0mm 2R1NST00332026-01-19
B1132R1NST00360Shoulder Innovations Inset Reverse Total ShoulderN22 Standard EZ Glenosphere - 36mm Diameter x 0mm 2R1NST00362026-01-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840097535678Veritas rTSARestor3d, Inc.PHX2026-06-03
00840097535692Veritas rTSARestor3d, Inc.PHX2026-06-03
00840097535715Veritas rTSARestor3d, Inc.PHX2026-06-03
00840097535739Veritas rTSARestor3d, Inc.PHX2026-06-03
00840097535753Veritas rTSARestor3d, Inc.PHX2026-06-03
00840097535777Veritas rTSARestor3d, Inc.PHX2026-06-03
00840097535791Veritas rTSARestor3d, Inc.PHX2026-06-03
00840097535814Veritas rTSARestor3d, Inc.PHX2026-06-03
00840097535838Veritas rTSARestor3d, Inc.PHX2026-06-03
00840097535852Veritas rTSARestor3d, Inc.PHX2026-06-03
00840097535876Veritas rTSARestor3d, Inc.PHX2026-06-03
00840097535890Veritas rTSARestor3d, Inc.PHX2026-06-03
00840097534978Veritas rTSARestor3d, Inc.PHX2026-06-02
00840097534985Veritas rTSARestor3d, Inc.PHX2026-06-02
B1132A2HI000100Shoulder Innovations InSet 95 Humeral StemShoulder Innovations, Inc.MBF2026-05-28
08033390002233SMR SystemLIMACORPORATE SPAMBF2026-02-19
08033390002240SMR SystemLIMACORPORATE SPAMBF2026-02-19
08033390002257SMR SystemLIMACORPORATE SPAMBF2026-02-19
08033390050029SMR SystemLIMACORPORATE SPAMBF2026-02-19
08033390050036SMR SystemLIMACORPORATE SPAMBF2026-02-19
08033390115667SMR TT Hybrid GlenoidLIMACORPORATE SPAMBF2024-07-27
08033390115698SMR TT Hybrid GlenoidLIMACORPORATE SPAPHX2024-07-27
08033390115711SMR TT Hybrid GlenoidLIMACORPORATE SPAMBF2024-07-27
08033390108065SMR STEMLESSLIMACORPORATE SPAPHX2022-03-17
07613327507096REUNIONStryker GmbHPHX2021-11-02
07613327354317REUNIONStryker GmbHPHX2021-04-27
07613327354348REUNIONStryker GmbHPHX2021-04-27
07613327354362REUNIONStryker GmbHPHX2021-04-27
07613327354393REUNIONStryker GmbHPHX2021-04-27
07613327354409REUNIONStryker GmbHPHX2021-04-27