FDA.reportPublic FDA data

Shoulder Innovations InSet 95 Humeral Stem

Primary DI
B1132L2HS000120
Brand
Shoulder Innovations InSet 95 Humeral Stem
Company
Shoulder Innovations, Inc.
Model
12mm Reamer Sounder
Catalog number
2L2HS00012
Device description
Shoulder Innovations - InSet 95 Humeral Stem - Instrument: 12mm Reamer Sounder
Published
2024-09-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K102670000
K110905000
K111596000
K173824000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K102670000TOTAL SHOULDER SYSTEMShoulder Innovations, LLC2011-01-24KWS
K110905000TOTAL SHOULDER SYSTEMShoulder Innovations, LLC2011-05-24KWS
K111596000TOTAL SHOULDER SYSTEMShoulder Innovations, LLC2011-07-05KWS
K173824000Humeral Short Stem SystemShoulder Innovations, Inc.2018-10-23MBF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B1132L2HS000120PrimaryHIBCC0

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
B1132R2HC300100Shoulder Innovations RSA Glenosphere Trial Instrument CaseRSA Glenosphere Trial Instrument Case2R2HC300102026-09-30
B1132N2GI200050Shoulder Innovations InSet GO20 mm x 5°2N2GI200052026-09-18
B1132N2GI200100Shoulder Innovations InSet GO20 mm x 10°2N2GI200102026-09-18
B1132N2GI206000Shoulder Innovations InSet GO20 mm x 6mm2N2GI206002026-09-18
B1132N2GI208000Shoulder Innovations InSet GO20 mm x 8mm2N2GI208002026-09-18
B1132N2GI220050Shoulder Innovations InSet GO22 mm x 5°2N2GI220052026-09-18
B1132N2GI220100Shoulder Innovations InSet GO22 mm x 10°2N2GI220102026-09-18
B1132N2GI226000Shoulder Innovations InSet GO22 mm x 6mm2N2GI226002026-09-18
B1132N2GI228000Shoulder Innovations InSet GO22 mm x 8mm2N2GI228002026-09-18
B1132N2GI240050Shoulder Innovations InSet GO24 mm x 5°2N2GI240052026-09-18
B1132N2GI240100Shoulder Innovations InSet GO24 mm x 10°2N2GI240102026-09-18
B1132N2GI246000Shoulder Innovations InSet GO24 mm x 6mm2N2GI246002026-09-18
B1132N2GI248000Shoulder Innovations InSet GO24 mm x 8mm2N2GI248002026-09-18
B1132N2GI270050Shoulder Innovations InSet GO27 mm x 5°2N2GI270052026-09-18
B1132N2GI270100Shoulder Innovations InSet GO27 mm x 10°2N2GI270102026-09-18
B1132N2GI276000Shoulder Innovations InSet GO27 mm x 6mm2N2GI276002026-09-18
B1132N2GI278000Shoulder Innovations InSet GO27 mm x 8mm2N2GI278002026-09-18
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07630542795602Anatomic Shoulder ProsthesisMedacta International SAKWS2026-09-28
07630542795817Anatomic Shoulder ProsthesisMedacta International SAKWS2026-09-28
07630542795824Anatomic Shoulder ProsthesisMedacta International SAKWS2026-09-28
07630542795831Anatomic Shoulder ProsthesisMedacta International SAKWS2026-09-28
07630542795848Anatomic Shoulder ProsthesisMedacta International SAKWS2026-09-28
07630542795855Anatomic Shoulder ProsthesisMedacta International SAKWS2026-09-28
07630542795879Anatomic Shoulder ProsthesisMedacta International SAKWS2026-09-28
00811596033460CSR Shoulder SystemCATALYST ORTHOSCIENCE INC.KWT2026-09-22
00811596033477CSR Shoulder SystemCATALYST ORTHOSCIENCE INC.KWT2026-09-22
00811596033484CSR Shoulder SystemCATALYST ORTHOSCIENCE INC.KWT2026-09-22
03701037320440FX V135 Shoulder ProsthesisFX SOLUTIONSHSD2026-09-22
03701037320440FX V135 Shoulder ProsthesisFX SOLUTIONSKWT2026-09-22
03701037321188ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSHSD2026-09-22
00887868554391Signature™ Comprehensive®Orthosoft IncMBF2024-02-09
00887868554391Signature™ Comprehensive®Orthosoft IncKWT2024-02-09
00887868554391Signature™ Comprehensive®Orthosoft IncHSD2024-02-09
00887868554391Signature™ Comprehensive®Orthosoft IncKWS2024-02-09
00887868554407Signature™ Comprehensive®Orthosoft IncHSD2024-02-09
00887868554407Signature™ Comprehensive®Orthosoft IncKWT2024-02-09
00887868554407Signature™ Comprehensive®Orthosoft IncKWS2024-02-09
00887868554407Signature™ Comprehensive®Orthosoft IncMBF2024-02-09
00885556810613AETOS Shoulder SystemSmith & Nephew, Inc.HSD2023-02-13
00885556810613AETOS Shoulder SystemSmith & Nephew, Inc.KWS2023-02-13
00885556810613AETOS Shoulder SystemSmith & Nephew, Inc.KWT2023-02-13
00885556810057AETOS Shoulder SystemSmith & Nephew, Inc.HSD2023-02-08
00885556810057AETOS Shoulder SystemSmith & Nephew, Inc.KWS2023-02-08
00885556810057AETOS Shoulder SystemSmith & Nephew, Inc.KWT2023-02-08
00885556810064AETOS Shoulder SystemSmith & Nephew, Inc.KWS2023-02-08
00885556810064AETOS Shoulder SystemSmith & Nephew, Inc.HSD2023-02-08
00885556810064AETOS Shoulder SystemSmith & Nephew, Inc.KWT2023-02-08