(160 days)
Not Found
No
The document describes a mechanical knee prosthesis and its components, with no mention of AI or ML in its design, function, or testing.
Yes
The device is a partial knee arthroplasty system, which is a medical intervention designed to treat a medical condition (degenerative knee disease) and restore function, thereby classifying it as therapeutic.
No
The device description clearly states it is a "partial knee arthroplasty" system, meaning it is an implant used for treatment, not for diagnosing conditions.
No
The device description clearly outlines physical components made of metal and plastic materials intended for surgical implantation, which are hardware, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Description: The MOTO™ Partial Knee System is a knee prosthesis, which is an implant designed to replace damaged parts of the knee joint. It is surgically implanted inside the body.
- Intended Use: The intended use is for partial knee arthroplasty, which is a surgical procedure to replace a portion of the knee joint. This is a treatment, not a diagnostic test.
The provided information clearly describes a surgically implanted device used for treatment, not a device used for testing samples outside the body.
N/A
Intended Use / Indications for Use
The MOTO™ Partial Knee System is designed for cemented use in partial knee arthroplasty, if there is evidence of sufficient sound bone to seat and support the components. Partial replacement of the articulating surfaces of the knee is indicated when only one side of the joint is affected due to the compartmental primary degenerative or post-traumatic degenerative disease, previous tibial condyle or plateau fractures, deformity or revision of previous arthroplasty.
Product codes
HSX
Device Description
The MOTO™ Partial Knee System is a knee prosthesis designed for cemented use in medial compartment partial knee arthroplasty, if there is evidence of sufficient sound bone to seat and support the components. Partial replacement of the articulating surfaces of the knee is indicated when only one side of the joint is affected due to the compartmental primary degenerative or post-traumatic degenerative disease, previous tibial condyle or plateau fractures, deformity or revision of previous arthroplasty. The femoral component is made of cobalt-chromiummolybdenum (Co-Cr-Mo per ISO 5832-4), and the tibial component consists of an ultra-high molecular weight polyethylene (UHMWPE per ISO 5834-2 Type 1) insert, and a metal baseplate component (Ti-6Al-4V per ISO 5832-3). The MOTO™ Partial Knee System implants are offered sterile (via gamma irradiation or ethylene oxide), are intended for single use only, and may not be re-sterilized.
The Anatomic Femoral Component (cemented) is anatomically shaped and designed with two (2) fixation pegs for sizes 1 to 7 and three (3) fixation pegs for sizes 8 to 10. Available in ten (10) sizes (1 - 10), the femoral component is offered in both Right Medial (RM) and Left Medial (LM) options for each size.
The Medial Fixed Tibial Insert has a fixed design and is available in five (8) sizes (1 – 8). Each size is offered in six (6) levels of thickness (8, 9, 10, 11, 12, 14 mm).
The Medial Fixed Tibial Tray (cemented) has a fixed bearing design with one fixation keel and peg to ensure primary stability. Available in five (8) sizes (1 - 8), the Medial Fixed Tibial Tray are offered in both Right Medial (RM) and Left Medial (LM) options for each size.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
knee
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The following studies were performed to support substantial equivalence:
- Fatigue under dynamic physiological loads according to ASTM F1800
- Excessive wear according to ASTM F2083 .
- Sterilization validation in accordance with ANSI/AAMI/ISO 11137-1:2006. ● ANSI/AAMI/ISO 11137-2:2006 and ISO 11135-1:2007
- Accelerated and real time aging
- . Packaging validation
- Limulus Amebocyte Lysate (LAL) testing was evaluated to establish the device meets . pyrogen limit specifications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3520 Knee joint femorotibial metal/polymer non-constrained cemented prosthesis.
(a)
Identification. A knee joint femorotibial metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral condylar resurfacing component or components made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components made of ultra-high molecular weight polyethylene and are intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is written in a sans-serif font.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 3, 2017
Medacta International SA % Elizabeth Wheeler Manager, Regulatory Affairs Mapi USA, Inc 2343 Alexandria Drive, Suite 100 Lexington, Kentucky 40504
Re: K162084 Trade/Device Name: Moto Partial Knee System Regulation Number: 21 CFR 888.3520 Regulation Name: Knee Joint Femorotibial Metal/Polymer Non-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: HSX Dated: November 16, 2016 Received: November 17, 2016
Dear Elizabeth Wheeler:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Lori A. Wiggins -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
MOTO™ Partial Knee System
Indications for Use (Describe)
The MOTO™ Partial Knee System is designed for cemented use in partial knee arthroplasty, if there is evidence of sufficient sound bone to seat and support the components. Partial replacement of the articulating surfaces of the knee is indicated when only one side of the joint is affected due to the compartmental primary degenerative or post-traumatic degenerative disease, previous tibial condyle or plateau fractures, deformity or revision of previous arthroplasty.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
Image /page/3/Picture/1 description: The image shows the logo for Medacta International. The logo consists of two blue triangles on the left, followed by the word "Medacta" in blue. A yellow line is underneath the word "Medacta". The word "International" is in a smaller font below the yellow line, and a Swiss flag is on the right.
1 510(k) Summary
| Applicant/Sponsor: | Medacta International SA |
|---|---|
| Strada Regina | |
| 6874 Castel San Pietro (CH) | |
| Switzerland | |
| Phone (+41) 91 696 60 60 | |
| Fax (+41) 91 696 60 66 |
- Contact Person: Stefano Baj Regulatory Affairs Manager Phone: +41 91 696 60 60 Fax: +41 91 696 60 66 Email: baj@medacta.ch
| Date Prepared: | July 26, 2016 |
|---|---|
| Date Revised: | November 16, 2016 |
DEVICE INFORMATION
| Trade/Proprietary Name: | MOTO™ Partial Knee System |
|---|---|
| Common or Usual Name: | Unicompartmental Knee prosthesis |
| Classification Name: | Knee joint femorotibial metal/polymer/ non-constrained cemented |
| prosthesis | |
| Product Code: | HSX |
| Regulation Number: | 21 CFR 888.3520 |
| Device Class: | II |
PREDICATE DEVICE INFORMATION
Primary predicates:
| 510(k) | Product | 510(k) Holder |
|---|---|---|
| K073175 | Journey | Smith & Nephew |
Additional predicates:
| 510(k) | Product | 510(k) Holder |
|---|---|---|
| K102069 | Journey | Smith & Nephew |
| K033363 | UNI | Zimmer |
4
DEVICE DESCRIPTION
The MOTO™ Partial Knee System is a knee prosthesis designed for cemented use in medial compartment partial knee arthroplasty, if there is evidence of sufficient sound bone to seat and support the components. Partial replacement of the articulating surfaces of the knee is indicated when only one side of the joint is affected due to the compartmental primary degenerative or post-traumatic degenerative disease, previous tibial condyle or plateau fractures, deformity or revision of previous arthroplasty. The femoral component is made of cobalt-chromiummolybdenum (Co-Cr-Mo per ISO 5832-4), and the tibial component consists of an ultra-high molecular weight polyethylene (UHMWPE per ISO 5834-2 Type 1) insert, and a metal baseplate component (Ti-6Al-4V per ISO 5832-3). The MOTO™ Partial Knee System implants are offered sterile (via gamma irradiation or ethylene oxide), are intended for single use only, and may not be re-sterilized.
The Anatomic Femoral Component (cemented) is anatomically shaped and designed with two (2) fixation pegs for sizes 1 to 7 and three (3) fixation pegs for sizes 8 to 10. Available in ten (10) sizes (1 - 10), the femoral component is offered in both Right Medial (RM) and Left Medial (LM) options for each size.
The Medial Fixed Tibial Insert has a fixed design and is available in five (8) sizes (1 – 8). Each size is offered in six (6) levels of thickness (8, 9, 10, 11, 12, 14 mm).
The Medial Fixed Tibial Tray (cemented) has a fixed bearing design with one fixation keel and peg to ensure primary stability. Available in five (8) sizes (1 - 8), the Medial Fixed Tibial Tray are offered in both Right Medial (RM) and Left Medial (LM) options for each size.
INDICATIONS FOR USE
The MOTO™ Partial Knee System is designed for cemented use in partial knee arthroplasty, if there is evidence of sufficient sound bone to seat and support the components. Partial replacement of the articulating surfaces of the knee is indicated when only one side of the joint is affected due to the compartmental primary degenerative or post-traumatic degenerative disease. previous tibial condyle or plateau fractures, deformity or revision of previous arthroplasty.
Discussion:
The Indications for Use Statement is similar to the predicate device. The only difference is that the subject device calls out the requirements for "evidence of sufficient sound bone to seat and support the components", and the predicate device cites specific example of degenerative joint disease ("osteoarthritis, traumatic arthritis, or avascular necrosis"). These differences do not create new intended uses for the subject device: the subject and predicate devices are all prostheses intended for use in knee arthroplasty.
5
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
The design features, and materials of the subject devices are substantially equivalent to those of the predicate devices. The tables below compare characteristics of the subject and predicate devices.
| Feature | MOTO™ Partial Knee
System - Anatomic
Femoral Component
(cemented) | Smith & Nephew
Journey
(K073175) | Zimmer UNI
(K033363) |
|-----------------------|----------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------|-------------------------|
| Sizes | 10 sizes (Size 1-10) | 7 sizes (Size 1 -7) | 7 sizes (Size A - G) |
| Configuration | RM and LM | RM/LL and LM/RL | RM/LL and LM/RL |
| Material | CoCrMo - ISO 5832-4 | Same
(with an oxinium
oxidized zirconium
coating) | Same |
| Cemented? | Yes | Same | Same |
| Device Usage | Single Use | Same | Same |
| Sterility | Provided sterile via
Gamma Radiation | Same | Same |
| Shelf Life | 5 Years | Same | > 5 Years |
| Stabilization
pegs | Anatomic Femoral
component is cemented
with two (2) pegs for
sizes 1-7 and three (3)
pegs for sizes 8-10 | 2 Pegs | 2 Pegs |
| Feature | MOTO™ Partial Knee System-
Fixed Tibial Insert | Zimmer UNI
(K033363) |
|--------------|----------------------------------------------------------------------------|-------------------------|
| Sizes | 8 sizes (from 1 to 8) | 6 sizes (from 1 to 6) |
| Thickness | Each size is offered in 6 levels of
thickness (8, 9, 10, 11, 12, 14 mm) | Same |
| Material | UHMWPE (ISO 5834 -2) Type 1 | Same |
| Device Usage | Single Use | Same |
| Sterility | Provided sterile via Ethylene Oxide | Same |
| Shelf Life | 5 years | > 5 years |
6
| Feature | MOTO™ Partial
Knee System - Fixed
Plus Tibial Tray
(cemented) | Smith & Nephew
Journey (K102069) | Zimmer UNI
(K033363) |
|----------------|------------------------------------------------------------------------|-------------------------------------|--------------------------------|
| Sizes | 8 sizes (from 1 to 8) | 6 sizes | 6 sizes (from 1 to 6) |
| Configurations | RM and LM | RM/LL and LM/RL | Same |
| Material | Ti-6Al-4V (ISO 5832-
3) | Same | Ti-6Al-4V with PMMA
precoat |
| Cemented | Cemented | Same | Same |
| Device Usage | Single Use | Same | Same |
| Sterility | Provided sterile via
Gamma Radiation | Unknown | Same |
| Shelf Life | 5 years | Unknown | > 5 years |
| Stabilization | Stabilized with peg and
keel | Same | Same |
| Fixed Bearing? | Yes | Same | Same |
The fundamental scientific technology of the modified devices has not changed relative to the predicate devices. The safety and effectiveness of the subject devices is adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification.
PERFORMANCE TESTING
The following studies were performed to support substantial equivalence:
- Fatigue under dynamic physiological loads according to ASTM F1800
- Excessive wear according to ASTM F2083 .
- Sterilization validation in accordance with ANSI/AAMI/ISO 11137-1:2006. ● ANSI/AAMI/ISO 11137-2:2006 and ISO 11135-1:2007
- Accelerated and real time aging
- . Packaging validation
- Limulus Amebocyte Lysate (LAL) testing was evaluated to establish the device meets . pyrogen limit specifications.
Conclusion:
Based on the above information, the MOTO™ Partial Knee System can be considered substantially equivalent to the identified predicate devices.