FDA.reportPublic FDA data

MyShoulder Planner

Primary DI
07630542730153
Brand
MyShoulder Planner
Company
Medacta International SA
Model
5.3SSWPL
Device description
MyShoulder Planner Software
Published
2025-02-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
LLZSystem, Image Processing, Radiological
QHEShoulder Arthroplasty Implantation System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer CementedOrthopedic2
LLZSystem, Image Processing, RadiologicalRadiology2
QHEShoulder Arthroplasty Implantation SystemOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K241292000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K241292000MyShoulder Planner (5.3SSWPL)Medacta International S.A.2025-01-30KWS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07630542730153PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630542730153076305427301537630542730153

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic/craniofacial implantation planning softwareA software program intended to add specific computer-assisted display, processing, and/or analysis capabilities to prepare for the implantation of an orthopaedic and/or craniomaxillofacial (CMF) prosthesis. Using digitized x-rays or imported computed tomography (CT) images, it provides implant-site anatomical images, and using computerized files representing implant patterns, provides the surgeon with images that help determine the appropriate size and placement of the implant.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
488227125
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07630971230156Spine Instruments03.30.10.20372026-05-12
07630971236745Spine Instruments03.30.10.20382026-05-12
07630971236752Spine Instruments03.30.10.20392026-05-12
07630971236769Spine Instruments03.30.10.20402026-05-12
07630971236776Spine Instruments03.30.10.20412026-05-12
07630971236783Spine Instruments03.30.10.20422026-05-12
07630971236790Spine Instruments03.30.10.20432026-05-12
07630971236806Spine Instruments03.30.10.20442026-05-12
07630971236813Spine Instruments03.30.10.20452026-05-12
07630971236820Spine Instruments03.30.10.20462026-05-12
07630542763748MectaLIF 3D Metal Anterior03.38.0012026-05-08
07630542763755MectaLIF 3D Metal Anterior03.38.0022026-05-08
07630542763762MectaLIF 3D Metal Anterior03.38.0032026-05-08
07630542763779MectaLIF 3D Metal Anterior03.38.0042026-05-08
07630542763786MectaLIF 3D Metal Anterior03.38.0052026-05-08
07630542763793MectaLIF 3D Metal Anterior03.38.0062026-05-08
07630542763809MectaLIF 3D Metal Anterior03.38.0072026-05-08
07630542763816MectaLIF 3D Metal Anterior03.38.0082026-05-08
07630542763823MectaLIF 3D Metal Anterior03.38.0092026-05-08
07630542763830MectaLIF 3D Metal Anterior03.38.0102026-05-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B1132A2HI000100Shoulder Innovations InSet 95 Humeral StemShoulder Innovations, Inc.KWS2026-05-28
M722CD26127V260970ClearRead CT DockerRiverain Technologies, Inc.LLZ2026-05-28
17540262200096Change Healthcare Stratus Imaging Diagnostic ViewerChange Healthcare Canada CompanyLLZ2026-05-27
75401622522101Synthesis Vision ViewerSynthesis Health Intelligence IncLLZ2026-05-27
EOLENEUROINSIGHTV1P00Neuro InsightOlea Medical USALLZ2026-04-13
EOLENEUROVASIV1P00Neurovascular InsightOlea Medical USALLZ2026-04-13
07613252286578FLUOROMAPStryker Leibinger GmbH & Co. KGLLZ2025-01-28
07613252286622FLUOROMAPStryker Leibinger GmbH & Co. KGLLZ2025-01-28
07613327603361REUNIONStryker GmbHKWS2024-10-01
07630542715679Advanced MyHip PlannerMedacta International SALLZ2023-01-26
07630030855818MyHip bone modelMedacta International SALLZ2023-01-23
07630030855825MyHip bone modelMedacta International SALLZ2023-01-23
07630030855832MyHip bone modelMedacta International SALLZ2023-01-23
07630030855849MyHip bone modelMedacta International SALLZ2023-01-23
07630345729286Advanced MyHip PlannerMedacta International SALLZ2023-01-23
07613327354331REUNIONStryker GmbHKWS2022-11-15
07613327354355REUNIONStryker GmbHKWS2022-11-15
07613327354805REUNIONStryker GmbHKWS2022-11-15
07613327354904REUNIONStryker GmbHKWS2022-11-15
07613327354935REUNIONStryker GmbHKWS2022-11-15
07613327354942REUNIONStryker GmbHKWS2022-11-15
07613327355024REUNIONStryker GmbHKWS2022-11-15
07613327355093REUNIONStryker GmbHKWS2022-11-15
07613327355109REUNIONStryker GmbHKWS2022-11-15
07613327355222REUNIONStryker GmbHKWS2022-11-15
07613327355246REUNIONStryker GmbHKWS2022-11-15
07613327355260REUNIONStryker GmbHKWS2022-11-15
07613327355291REUNIONStryker GmbHKWS2022-11-15
07613327355345REUNIONStryker GmbHKWS2022-11-15
07613327355369REUNIONStryker GmbHKWS2022-11-15