(81 days)
Not Found
No
The summary describes a mechanical knee implant system and its materials, with no mention of AI/ML in the device description, intended use, or performance studies.
Yes
The device is described as "intended for total knee replacement" to "relieve pain and restore knee functions," which directly addresses a medical condition and aims to improve a patient's health, fitting the definition of a therapeutic device.
No
Explanation: The device is a total knee replacement system intended to relieve pain and restore knee function. It is an implant used for treatment, not for diagnosing conditions.
No
The device description explicitly lists physical components made of materials like Cobalt Chrome, titanium alloy, and UHMWPE, which are implanted during surgery. This indicates it is a hardware medical device, not software-only.
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 the body.
- Madison Knee System Function: The description clearly states the Madison Knee System is intended for total knee replacement. It is a set of implantable components (femoral component, tibial insert, etc.) that are surgically placed inside the body to replace a damaged knee joint.
- No Mention of Testing Samples: The description focuses on the physical components of the knee system, their materials, and their intended use in surgery. There is no mention of collecting or testing biological samples.
Therefore, based on the provided information, the Madison Knee System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Madison Knee System is intended for total knee replacement. Madison Knee components are for use in total knee arthroplasty to relieve pain and restore knee functions such as: painful, disabling joint disease of the knee resulting from degenerative arthritis , theumatoid arthritis; and revision of previous unsuccessful knee replacement or other procedure. These components are indicated for cemented fixation only.
Product codes (comma separated list FDA assigned to the subject device)
JWH
Device Description
The Madison Total Knee System is a modular knee system consisting of a femoral component, tibial insert, tibial baseplate, tibial stem extensions, and a patella. The system components are designed to be Cruciate-Retaining and Ultra-Congruent. The femoral component and tibial baseplate are manufactured from Cobalt Chrome and are to be implanted with cement. The tibial stem extensions are manufactured from titanium alloy, and the tibial insert and patella components are manufactured from UHMWPE. All implant components are provided sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical Testing: All necessary testing has been performed for the worst-case Madison Total Knee System components to assure substantial equivalence to the predicate device and demonstrate the device performs as intended. All testing was performed on test units representative of finished devices. Clinical data were not needed to support the safety and effectiveness of the subject device. The device performance was characterized through the following tests: - Range of Motion (Tibiofemoral) as per ASTM F2083 - Constraint (Tibiofemoral) as per ASTM F1223 - Contact Area/Contact Stress (Tibiofemoral) - Component Interlock Strength - Range of Motion/Constraint (Patellofemoral) as per ASTM F1223 - Contact Area/Contact Stress (Patellofemoral) - Tibial Baseplate Cantilever Fatigue as per ASTM F1800 - UHMWPE Characterization as per ASTM F648 - Bacterial Endotoxin Testing
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
October 22, 2019
Implanet, S.A. % Hollace Rhodes Vice President, Orthopedic Regulatory Affairs MCRA. LLC 1050 K Street NW, Suite 1000 Washington, District of Columbia 20001
Re: K192084
Trade/Device Name: Madison Total Knee System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee Joint Patellofemorotibial Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: JWH Dated: August 2, 2019 Received: August 2, 2019
Dear Hollace Rhodes:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For Ting Song Acting Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K192084
Device Name Madison Total Knee System
Indications for Use (Describe)
The Madison Knee System is intended for total knee replacement. Madison Knee components are for use in total knee arthroplasty to relieve pain and restore knee functions such as: painful, disabling joint disease of the knee resulting from degenerative arthritis , theumatoid arthritis; and revision of previous unsuccessful knee replacement or other procedure. These components are indicated for cemented fixation only.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW *
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary
| Device Trade Name: | Madison Total Knee System |
|---|---|
| Common Name: | Total Knee Prosthesis |
| Manufacturer: | Implanet, S.A. |
| Technopole Bordeaux Montesquieu | |
| Allée Francois Magendie | |
| 33650 Martillac | |
| France | |
| Phone: (+33) 557 995 555 | |
| Facsimile: (+33) 557 995 700 | |
| Contact: | Régis Le Couëdic |
| Regulatory Affairs & Quality Director | |
| Phone: +33 685 22 26 55 | |
| Email: rlc@implanet.com | |
| Prepared by: | MCRA, LLC |
| 1050 K Street NW, Suite 1000 | |
| Washington, DC 20001 | |
| Phone: (202) 552-5800 | |
| Date Prepared: | October 1, 2019 |
| Classification: | 21 CFR 888.3560 |
| Class: | II |
| Product Code: | JWH |
Indications for Use:
The Madison Knee System is intended for total knee replacement. Madison Knee components are for use in total knee arthroplasty to relieve pain and restore knee functions for indications such as: painful, disabling joint disease of the knee resulting from degenerative arthritis, theumatoid arthritis or post-traumatic arthritis; and revision of previous unsuccessful knee replacement or other procedure. These components are indicated for cemented fixation only.
Device Description:
The Madison Total Knee System is a modular knee system consisting of a femoral component, tibial insert, tibial baseplate, tibial stem extensions, and a patella. The system components are designed to be Cruciate-Retaining and Ultra-Congruent. The femoral component and tibial baseplate are manufactured from Cobalt Chrome and are to be implanted with cement. The tibial stem extensions are manufactured from titanium alloy, and the tibial insert and patella components are manufactured from UHMWPE. All implant components are provided sterile.
4
Predicate Device:
The Scorpio NRG Knee System (K915192, K071991) serves as the predicate device.
Technological Characteristics Comparison:
The Madison Total Knee System and its predicate device are similar in size, material, and geometry. Both the subject and predicate devices are fixed, cruciate-retaining, and are to be used with bone cement. Both systems are semi-constrained and utilize a metal-on-polyethylene articulation. There are no substantial differences in technological characteristics between the two devices and as such the Madison Total Knee System introduces no new issues of safety or effectiveness.
Nonclinical Testing:
All necessary testing has been performed for the worst-case Madison Total Knee System components to assure substantial equivalence to the predicate device and demonstrate the device performs as intended. All testing was performed on test units representative of finished devices. Clinical data were not needed to support the safety and effectiveness of the subject device.
The device performance was characterized through the following tests:
- Range of Motion (Tibiofemoral) as per ASTM F2083 ●
- Constraint (Tibiofemoral) as per ASTM F1223 ●
- Contact Area/Contact Stress (Tibiofemoral)
- Component Interlock Strength
- Range of Motion/Constraint (Patellofemoral) as per ASTM F1223
- Contact Area/Contact Stress (Patellofemoral) ●
- Tibial Baseplate Cantilever Fatigue as per ASTM F1800 ●
- UHMWPE Characterization as per ASTM F648 ●
- Bacterial Endotoxin Testing
Conclusion:
The Madison Total Knee is substantially equivalent to the predicate device with respect to its indications for use, design, function, and method of fixation.