MyKnee
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- MyKnee U STD FemDisCutBl-CT-GMK-LM-#2 EUDAMEDMyKnee FDA UDI
- Generic Name
- Orthopaedic prosthesis implantation positioning instrument, single-use FDA UDI
- Device Name
- MyKnee U STD FemDisCutBl-CT-GMK-LM-#2 FDA UDI
- Model / Reference
- 24.1012 EUDAMEDFDA UDIKnee Cutting guide TKA - not sterile EUDAMED
- Description
- MyKnee U STD FemDisCutBl-CT-GMK-LM-#2 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07630345759993 EUDAMEDFDA UDI
- Basic UDI-DI
- 764014274KSP0902N00BP EUDAMED
- 510(k) Number
- K093806 FDA UDI
- FDA Product Code
- JWH FDA UDI
- EMDN Code
- K01020114 MINIMALLY INVASIVE SURGERY GUIDES, SINGLE-USE EUDAMED
- GMDN Term
- Orthopaedic prosthesis implantation positioning instrument, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3560 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Orthopaedic prosthesis implantation positioning instrument, single-use
MyKnee by Medacta International — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic prosthesis implantation positioning instrument, single-use.
- AGILITY — DEPUY ORTHOPAEDICS, INC. · Class I
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- MOTOBAND CP — CROSSROADS EXTREMITY SYSTEMS LLC · Class I
- MOTOBAND CP — CROSSROADS EXTREMITY SYSTEMS LLC · Class I
- MOTOBAND CP — CROSSROADS EXTREMITY SYSTEMS LLC · Class I
- Comprehensive® Reverse Shoulder Augmented Guide and Bone Model Left — Orthosoft Inc · Class II
- MyKnee PPS — Medacta International · Class II
Cleared under the same submission
K093806 also covers:
- My Knee — Medacta International
- My Knee Bone Models — Medacta International
- My Knee Femoral Cutting Blocks — Medacta International
- My Knee Femoral Cutting Blocks MIS — Medacta International
- My Knee Femoral Cutting Blocks MIS — Medacta International
- My Knee Femoral Cutting Blocks MIS — Medacta International
- My Knee Femoral Cutting Blocks MIS — Medacta International
- My Knee Tibial Cutting Blocks — Medacta International
- My Knee Tibial Cutting Blocks — Medacta International
- My Knee Tibial Cutting Blocks — Medacta International
- My Knee Tibial Cutting Blocks MIS — Medacta International
- My Knee Tibial Cutting Blocks MIS — Medacta International
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Medacta International
Sources (2)
- FDA UDI b1833e87-c40f-45c0-9860-4c021e26ed2b 34 fields · synced Oct 9, 2026
- EUDAMED cfce3509-f878-4573-87c1-f5124cf7e03a 61 fields · synced Oct 9, 2026