FDA.reportPublic FDA data

MyPAO

Primary DI
07630542724497
Brand
MyPAO
Company
Medacta International SA
Model
12.9043
Device description
MyPAO Real-Sys Bone Model SA Pre-Op Left
Published
2025-12-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
PBFOrthopaedic Surgical Planning And Instrument Guides

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PBFOrthopaedic Surgical Planning And Instrument GuidesOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K242603000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K242603000MyPAO SA guidesMedacta International S.A.2025-11-19PBF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07630542724497PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630542724497076305427244977630542724497

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic prosthesis implantation positioning instrument, single-useA 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, prosthesis, or prosthesis component; 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 single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
488227125
Device count
1
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07630971243637AMIStem-P Short Neck01.18.4592020-01-29
07630971243644AMIStem-P Short Neck01.18.4602020-01-29
07630971243651AMIStem-P Short Neck01.18.4612020-01-29
07630971243668AMIStem-P Short Neck01.18.4622020-01-29
07630971243675AMIStem-P Short Neck01.18.4632020-01-29
07630971243682AMIStem-P Short Neck01.18.4642020-01-29
07630971243699AMIStem-P Short Neck01.18.4652020-01-29
07630971243705AMIStem-P Short Neck01.18.4662020-01-29
07630971243712AMIStem-P Short Neck01.18.4672020-01-29
07630971243729AMIStem-P Short Neck01.18.4682020-01-29
07630971243736AMIStem-P Short Neck01.18.4692020-01-29
07630971243743AMIStem-P Short Neck01.18.4702020-01-29
07630971243750AMIStem-P Short Neck01.18.4712020-01-29
07630971243767AMIStem-P Short Neck01.18.4722020-01-29
07630971243774AMIStem-P Short Neck01.18.4732020-01-29
07630971243781AMIStem-P Short Neck01.18.4742020-01-29
07630971243798AMIStem-P Short Neck01.18.4752020-01-29
07630971243804AMIStem-P Short Neck01.18.4762020-01-29
07630971243811AMIStem-P Short Neck01.18.4772020-01-29
07630971243828AMIStem-P Short Neck01.18.4782020-01-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07630345779939NextAR Spine Platform Medacta International SAPBF2023-07-24
07630345797063NextAR Spine Platform Medacta International SAPBF2023-07-24
07630345797070NextAR Spine Platform Medacta International SAPBF2023-07-24
07630345797087NextAR Spine Platform Medacta International SAPBF2023-07-24
G2710300240140IntelliguidesMios Marketing, LLCPBF2023-01-01
G2710310240150IntelliguidesMios Marketing, LLCPBF2023-01-01
G2710310240160IntelliguidesMios Marketing, LLCPBF2023-01-01
G2710310240180IntelliguidesMios Marketing, LLCPBF2023-01-01
G2710310240190IntelliguidesMios Marketing, LLCPBF2023-01-01
G2710310240200IntelliguidesMios Marketing, LLCPBF2023-01-01
G2710310240210IntelliguidesMios Marketing, LLCPBF2023-01-01
G2710310240220IntelliguidesMios Marketing, LLCPBF2023-01-01
G2710310240230IntelliguidesMios Marketing, LLCPBF2023-01-01
G2710310240240IntelliguidesMios Marketing, LLCPBF2023-01-01
G2710310240250IntelliguidesMios Marketing, LLCPBF2023-01-01
G2710310260150IntelliguidesMios Marketing, LLCPBF2023-01-01
G2710310260160IntelliguidesMios Marketing, LLCPBF2023-01-01
G2710310260170IntelliguidesMios Marketing, LLCPBF2023-01-01
G2710310260180IntelliguidesMios Marketing, LLCPBF2023-01-01
G2710310260190IntelliguidesMios Marketing, LLCPBF2023-01-01
G2710310260200IntelliguidesMios Marketing, LLCPBF2023-01-01
G2710310260210IntelliguidesMios Marketing, LLCPBF2023-01-01
G2710310260220IntelliguidesMios Marketing, LLCPBF2023-01-01
G2710310260230IntelliguidesMios Marketing, LLCPBF2023-01-01
G2710310260240IntelliguidesMios Marketing, LLCPBF2023-01-01
G2710310260250IntelliguidesMios Marketing, LLCPBF2023-01-01
G2710310280150IntelliguidesMios Marketing, LLCPBF2023-01-01
G2710310280160IntelliguidesMios Marketing, LLCPBF2023-01-01
G2710310280170IntelliguidesMios Marketing, LLCPBF2023-01-01
G2710310280180IntelliguidesMios Marketing, LLCPBF2023-01-01