Mako Surgical Corp. Patellofemoral Knee Implant System II
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- Mako EUDAMEDNA FDA UDI
- Generic Name
- Surgical instrument handle, non-torque-limiting FDA UDI
- Device Name
- TD-01 - MAKO - Class I - Clinical Trays and Bowles - Metal and Plastic EUDAMEDTD-01 - MAKO - Class I - Orthopedic Prosthesis Instruments - Plastic EUDAMEDFixed Driver Handle FDA UDI
- Model / Reference
- 111157 EUDAMEDFDA UDI08858251002237SK EUDAMED700002606022 EUDAMED08858251002240S8 EUDAMED
- Description
- Fixed Driver Handle FDA UDI
Identifiers
- Catalog Number
- 111157 FDA UDI
- Primary DI / UDI-DI
- 00848486002756 EUDAMEDFDA UDI07613327623277 EUDAMED
- Basic UDI-DI
- 08858251002237SK EUDAMED08858251002240S8 EUDAMED
- Direct Marketing DI
- 07613327623277 EUDAMED00848486002756 EUDAMED
- FDA Product Code
- KRR FDA 510(k)OLO FDA UDI
- EMDN Code
- V0402 CLINICAL USE TRAYS AND BOWLS EUDAMEDL091199 ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Surgical instrument handle, non-torque-limiting FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 888.3540 FDA 510(k)
- Regulation Number
- 888.3540 FDA 510(k)882.4560 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
Yes
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
No
Manufacturing Date
No
The Patellofemoral Knee Implant System II is a Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer (per OpenFDA nomenclature). It is designed as a cemented orthopedic implant for patellofemoral joint replacement, featuring a cobalt-chromium-molybdenum (CoCrMo) trochlear component paired with an ultra-high-molecular-weight polyethylene (UHMWPE) patella component. This system is intended for use in patients with degenerative arthritis, patellar instability, or prior patellar surgery failures, providing a semi-constrained articulation to restore joint function and alignment.
The system is supplied as a single-use, sterile orthopedic implant, intended for use in cemented patellofemoral arthroplasty procedures. Components are MRI-unsafe due to metal content and must be handled in accordance with standard orthopedic implant protocols. Available in multiple sizes (as referenced by FEI numbers), it requires surgical implantation by trained orthopedic surgeons in a controlled operating environment. Authorized under FDA 510K clearance (K082088) and MDR compliance, the device adheres to regulatory standards for Class II medical devices.
Frequently asked questions
What types of patients is this patellofemoral knee implant system designed for?
The Patellofemoral Knee Implant System II is specifically designed for patients with degenerative arthritis, patellar instability, or prior patellar surgery failures. It is intended to restore joint function and alignment in these conditions through a semi-constrained articulation.
Is this implant reusable or intended for single-use only?
The Patellofemoral Knee Implant System II is explicitly supplied as a single-use device. Each component is intended for one surgical procedure only and must not be reused.
How many sizes are available for this implant system, and how are they identified?
The system is available in multiple sizes, each identified by a unique FEI (Federal Equipment Identifier) number. There are over 100 distinct FEI numbers listed, such as 3005706667, 1000114185, and 3002806725, which correspond to different component sizes for patient-specific fitting.
Can this implant be used with MRI imaging, and what precautions should be taken during surgery?
No, the Patellofemoral Knee Implant System II contains metal components (cobalt-chromium-molybdenum), making it MRI-unsafe. Surgical teams must follow standard orthopedic implant protocols, including proper handling and disposal, and avoid MRI exposure post-implantation.
What regulatory pathways does this device follow, and what does that mean for its use?
The system is authorized under FDA 510K clearance (K082088) and MDR compliance, confirming it meets regulatory standards for Class II medical devices. This means it has undergone rigorous review for safety and effectiveness, ensuring it can be legally used in clinical settings as described in its labeling.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Mako Surgical Corp. Patellofemoral Knee Implant System Ii, PDF MAKO OCT2 200 SURGICAL CGRR. - Food and Drug Administration, PDF 2583 - Mako_PKA patellofemoral surgical reference guide update
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K082088 | Class II | Active |
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Manufacturer
- Manufacturer
- MAKO Surgical Corp.
Sources (4)
- FDA 510(k) K082088 24 fields · synced Sep 20, 2026
- FDA UDI 2ee4857e-8bc1-4da5-8105-79da4034c627 35 fields · synced May 30, 2026
- EUDAMED 435fe9a8-a24e-4eeb-88c8-3bac2749f23f 61 fields · synced Jul 12, 2026
- EUDAMED 5f202759-e2fd-408e-a7dd-6270afc4da65 61 fields · synced Aug 2, 2026