FDA.reportPublic FDA data

Shoulder Innovations InSet 95 Humeral Stem

Primary DI
B1132L2HI00002
Brand
Shoulder Innovations InSet 95 Humeral Stem
Company
Shoulder Innovations, Inc.
Model
Inserter
Catalog number
2L2HI00002
Device description
Shoulder Innovations - InSet 95 Humeral Stem - Instrument: Inserter
Published
2023-11-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
MBFProsthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MBFProsthesis, Shoulder, Semi-Constrained, Metal/Polymer, UncementedOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K102670000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K102670000TOTAL SHOULDER SYSTEMShoulder Innovations, LLC2011-01-24KWS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B1132L2HI00002PrimaryHIBCC0

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
616-294-1026xxx@xx.xx

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
false
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
B1132N1HG000000Shoulder Innovations Humeral Short Stem SystemK-Wire Guide2N1HG000002023-10-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00889024707047Signature ONE Software PackageOrthosoft IncMBF2026-07-10
00889024701540Identity® Shoulder SystemZimmer, Inc.MBF2026-06-10
00889024702127Comprehensive Reverse ShoulderZimmer, Inc.MBF2026-06-10
00889024702134Comprehensive Reverse ShoulderZimmer, Inc.MBF2026-06-10
00889024702141Comprehensive Reverse ShoulderZimmer, Inc.MBF2026-06-10
00889024702158Comprehensive Reverse ShoulderZimmer, Inc.MBF2026-06-10
00889024702165Comprehensive Reverse ShoulderZimmer, Inc.MBF2026-06-10
00889024702172Comprehensive Reverse ShoulderZimmer, Inc.MBF2026-06-10
00889024702189Comprehensive Reverse ShoulderZimmer, Inc.MBF2026-06-10
00889024702196Comprehensive Reverse ShoulderZimmer, Inc.MBF2026-06-10
00889024702202Comprehensive Reverse ShoulderZimmer, Inc.MBF2026-06-10
00889024704916Alliance Humeral BearingsZimmer, Inc.MBF2026-06-10
00889024704923Alliance Humeral BearingsZimmer, Inc.MBF2026-06-10
00889024704930Alliance Humeral BearingsZimmer, Inc.MBF2026-06-10
00889024704947Alliance Humeral BearingsZimmer, Inc.MBF2026-06-10
00889024704954Alliance Humeral BearingsZimmer, Inc.MBF2026-06-10
00889024704961Alliance Humeral BearingsZimmer, Inc.MBF2026-06-10
00889024704978Alliance Humeral BearingsZimmer, Inc.MBF2026-06-10
00889024704985Alliance Humeral BearingsZimmer, Inc.MBF2026-06-10
00889024704992Alliance Humeral BearingsZimmer, Inc.MBF2026-06-10
00889024705005Alliance Humeral BearingsZimmer, Inc.MBF2026-06-10
00889024705012Alliance Humeral BearingsZimmer, Inc.MBF2026-06-10
00889024705029Alliance Humeral BearingsZimmer, Inc.MBF2026-06-10
00889024705036Alliance Humeral BearingsZimmer, Inc.MBF2026-06-10
00889024705043Alliance Humeral BearingsZimmer, Inc.MBF2026-06-10
00889024705050Alliance Humeral BearingsZimmer, Inc.MBF2026-06-10
00889024705067Alliance Humeral BearingsZimmer, Inc.MBF2026-06-10
00889024705074Alliance Humeral BearingsZimmer, Inc.MBF2026-06-10
00889024705081Alliance Humeral BearingsZimmer, Inc.MBF2026-06-10
00889024705098Alliance Humeral BearingsZimmer, Inc.MBF2026-06-10