FDA.report

Shoulder Innovations InSet Humeral Stemless

Primary DI
B1132G2SC213200
Brand
Shoulder Innovations InSet Humeral Stemless
Company
Shoulder Innovations, Inc.
Model
32mm | Size 1
Catalog number
2G2SC21320
Device description
Shoulder Innovations - TSA - InSet Humeral Stemless - 32mm | Size 1
Published
2022-09-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
MBFProsthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented

Product Code Classifications

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

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B1132G2SC213200PrimaryHIBCC0

GMDN Terms

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
Radiation Sterilization

Contacts

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
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
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
B1132R1NET40420Shoulder Innovations Inset Reverse Total ShoulderN22 Eccentric EZ Glenosphere - 42mm Diameter x 4mm2R1NET40422026-01-19
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
B1132R1NST00390Shoulder Innovations Inset Reverse Total ShoulderN22 Standard EZ Glenosphere - 39mm Diameter x 0mm 2R1NST00392026-01-19
B1132R1NST00420Shoulder Innovations Inset Reverse Total ShoulderN22 Standard EZ Glenosphere - 42mm Diameter x 0mm 2R1NST00422026-01-19
B1132L1S0400020Shoulder Innovations InSet FxR 1354mmX1352L1S0400022025-12-12
B1132L1S0600020Shoulder Innovations InSet FxR 1356mmX1352L1S0600022025-12-12
B1132L1S0600030Shoulder Innovations InSet FxR 1856mmX1852L1S0600032025-12-12
B1132L1S0800020Shoulder Innovations InSet FxR 1358mmX1352L1S0800022025-12-12
B1132L1S0800030Shoulder Innovations InSet FxR 1858mmX1852L1S0800032025-12-12

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00889024691582Identity HumeralZimmer, Inc.MBF2025-09-22
B1130S1GK000030Shoulder Innovations InSet 70 Humeral StemShoulder Innovations, Inc.MBF2025-09-18
B1132L2HG700380Shoulder Innovations InSet 70 Humeral StemShoulder Innovations, Inc.MBF2025-09-18
B1132L2HS700040Shoulder Innovations InSet 70 Humeral StemShoulder Innovations, Inc.MBF2025-09-18
B1132L2HS700050Shoulder Innovations InSet 70 Humeral StemShoulder Innovations, Inc.MBF2025-09-18
00889024691506Identity HumeralZimmer, Inc.MBF2025-09-17
00889024691513Identity HumeralZimmer, Inc.MBF2025-09-17
00889024691520Identity HumeralZimmer, Inc.MBF2025-09-17
00889024691643Identity HumeralZimmer, Inc.MBF2025-09-17
00889024691650Identity HumeralZimmer, Inc.MBF2025-09-17
B1132L2HC000040Shoulder Innovations Inset Reverse Total ShoulderShoulder Innovations, Inc.MBF2025-09-13
B1132L1S0400000Shoulder Innovations InSet 70 Humeral StemShoulder Innovations, Inc.MBF2025-05-29
B1132L1S0600000Shoulder Innovations InSet 70 Humeral StemShoulder Innovations, Inc.MBF2025-05-29
B1132L1S0800000Shoulder Innovations InSet 70 Humeral StemShoulder Innovations, Inc.MBF2025-05-29
B1132L1S1000000Shoulder Innovations InSet 70 Humeral StemShoulder Innovations, Inc.MBF2025-05-29
B1132L1S1200000Shoulder Innovations InSet 70 Humeral StemShoulder Innovations, Inc.MBF2025-05-29
B1132L1S1400000Shoulder Innovations InSet 70 Humeral StemShoulder Innovations, Inc.MBF2025-05-29
B1132L2HI000040Shoulder Innovations InSet 70 Humeral StemShoulder Innovations, Inc.MBF2025-05-29
B1132L2HI000110Shoulder Innovations InSet 95 Humeral StemShoulder Innovations, Inc.MBF2025-05-12
B1132N1HS000400Shoulder Innovations TSAShoulder Innovations, Inc.MBF2025-04-18
B1132N1HS000460Shoulder Innovations TSAShoulder Innovations, Inc.MBF2025-04-18
B1132N1HS000520Shoulder Innovations TSAShoulder Innovations, Inc.MBF2025-04-18
B1132R2HC000050Shoulder Innovations IM Cut GuideShoulder Innovations, Inc.MBF2025-04-18
B1132R2HC000080Shoulder Innovations IM Cut GuideShoulder Innovations, Inc.MBF2025-04-18
B1132R2HC000090Shoulder Innovations IM Cut GuideShoulder Innovations, Inc.MBF2025-04-18
00887868580697Identity® Shoulder SystemZimmer, Inc.MBF2024-09-09
B1132L2HC000010Shoulder Innovations InSet 95 Humeral StemShoulder Innovations, Inc.MBF2024-09-01