FDA.reportPublic FDA data

MyPAO

Primary DI
07630542724473
Brand
MyPAO
Company
Medacta International SA
Model
12.9033
Device description
MyPAO Real-Sys Bone Model SA Post-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
07630542724473PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630542724473076305427244737630542724473

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
07630542762482GMK Extension02.12.0110APFL2026-09-18
07630542762499GMK Extension02.12.0110APFR2026-09-18
07630542762505GMK Extension02.12.0111APFL2026-09-18
07630542762512GMK Extension02.12.0111APFR2026-09-18
07630542762529GMK Extension02.12.0112APFL2026-09-18
07630542762536GMK Extension02.12.0112APFR2026-09-18
07630542762543GMK Extension02.12.0113APFL2026-09-18
07630542762550GMK Extension02.12.0113APFR2026-09-18
07630542762567GMK Extension02.12.0114APFL2026-09-18
07630542762574GMK Extension02.12.0114APFR2026-09-18
07630542762581GMK Extension02.12.0117APFL2026-09-18
07630542762598GMK Extension02.12.0117APFR2026-09-18
07630542762604GMK Extension02.12.0120APFL2026-09-18
07630542762611GMK Extension02.12.0120APFR2026-09-18
07630542762628GMK Extension02.12.0210APFL2026-09-18
07630542762635GMK Extension02.12.0210APFR2026-09-18
07630542762642GMK Extension02.12.0211APFL2026-09-18
07630542762659GMK Extension02.12.0211APFR2026-09-18
07630542762666GMK Extension02.12.0212APFL2026-09-18
07630542762673GMK Extension02.12.0212APFR2026-09-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00688346003918Fine TTOLaboratoires Bodycad IncPBF2026-08-03
00688346005356Fine Osteotomy System - Femoral plateLaboratoires Bodycad IncPBF2026-08-03
00688346005387Fine Osteotomy System - Femoral plateLaboratoires Bodycad IncPBF2026-08-03
00688346005523Fine Osteotomy System - Tibial plateLaboratoires Bodycad IncPBF2026-08-03
00688346005554Fine Osteotomy System - Tibial plateLaboratoires Bodycad IncPBF2026-08-03
00885556925379CORIOGRAPHSmith & Nephew, Inc.PBF2026-07-08
00885556925386CORIOGRAPHSmith & Nephew, Inc.PBF2026-07-08
054005500102173D-CUT3D-SidePBF2026-04-28
054005501506163D-CUT3D-SidePBF2026-04-28
054005501506233D-CUT3D-SidePBF2026-04-28
054005501506303D-CUT3D-SidePBF2026-04-28
054005501506473D-CUT3D-SidePBF2026-04-28
054005501506543D-CUT3D-SidePBF2026-04-28
054005501506613D-CUT3D-SidePBF2026-04-28
00840124525542FibFixFUSION ORTHOPEDICS, LLCPBF2026-04-23
00840124525559FibFixFUSION ORTHOPEDICS, LLCPBF2026-04-23
00840124525566FuzeFix LargeFUSION ORTHOPEDICS, LLCPBF2026-04-23
00840124525597FuzeFix LargeFUSION ORTHOPEDICS, LLCPBF2026-04-23
00840124516779FibFixFUSION ORTHOPEDICS, LLCPBF2026-04-09
00840124517783FibFixFUSION ORTHOPEDICS, LLCPBF2026-04-09
00840124525467FibFixFUSION ORTHOPEDICS, LLCPBF2026-04-09
00860009815780EmbedMed3D LIFEPRINTS UK LTDPBF2026-03-30
00840124521773PolyLock MidfootFUSION ORTHOPEDICS, LLCPBF2025-10-02
00840124521780PolyLock MidfootFUSION ORTHOPEDICS, LLCPBF2025-10-02
00840124521797PolyLock MidfootFUSION ORTHOPEDICS, LLCPBF2025-10-02
00840124521803PolyLock MidfootFUSION ORTHOPEDICS, LLCPBF2025-10-02
00840124521810PolyLock MidfootFUSION ORTHOPEDICS, LLCPBF2025-10-02
00840124521827PolyLock MidfootFUSION ORTHOPEDICS, LLCPBF2025-10-02
00840124521834PolyLock MidfootFUSION ORTHOPEDICS, LLCPBF2025-10-02
00840124521841PolyLock MidfootFUSION ORTHOPEDICS, LLCPBF2025-10-02