FDA.reportPublic FDA data

Shoulder Innovations IM Cut Guide

Primary DI
B1132R2HC000050
Brand
Shoulder Innovations IM Cut Guide
Company
Shoulder Innovations, Inc.
Model
IM Cut Guide Superior-Lateral Fixed Arm Assembly
Catalog number
2R2HC00005
Device description
Shoulder Innovations - IM Cut Guide Instrument - Superior-Lateral Fixed Arm Assembly
Published
2025-04-18
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
LXHOrthopedic Manual Surgical Instrument
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
LXHOrthopedic Manual Surgical InstrumentOrthopedic1
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
B1132R2HC000050PrimaryHIBCC0

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
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841523183081Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-08-07
00841523183746Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-08-07
00841523185030Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-08-07
00841523185047Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-08-07
00841523185054Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-08-07
00841523185061Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-08-07
00841523185078Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-08-07
00841523185092Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-08-07
00841523185108Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-08-07
00841523185139Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-08-07
00841523185146Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-08-07
00841523185153Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-08-07
00841523185160Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-08-07
00841523185177Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-08-07
00841523185382Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-08-07
B382SD484620Surgical DirectSurgical Direct, Inc.LXH2026-08-07
M7409200004MIS TLIF SystemSPINEOLOGY INC.LXH2026-08-07
00199150083473Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-08-03
03661489725463JARVIS Diaphyseal Stem StandardFOURNITURES HOSPITALIERES INDUSTRIEHSD2026-08-03
03661489725463JARVIS Diaphyseal Stem StandardFOURNITURES HOSPITALIERES INDUSTRIEKWS2026-08-03
B382SD480033220Surgical DirectSurgical Direct, Inc.LXH2026-08-03
B382SD480090Surgical DirectSurgical Direct, Inc.LXH2026-08-03
B382SD4834330Surgical DirectSurgical Direct, Inc.LXH2026-08-03
B382SD493760Surgical DirectSurgical Direct, Inc.LXH2026-08-03
00190776407391MillenniumAvalign Technologies, Inc.LXH2026-07-31
00840606191579Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191630Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191647Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191678Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191685Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31