(60 days)
No
The document describes a mechanical knee replacement system and its components. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The performance studies are based on mechanical and material testing, not data analysis or model performance.
Yes
The device is a total knee replacement system intended for the reduction or relief of pain and/or improved knee function in patients with various knee conditions, which are therapeutic goals.
No
Explanation: The device is a total knee replacement system, which is a prosthetic implant used in knee arthroplasty to treat conditions like degenerative joint disease and fractures. It is a therapeutic device, not a diagnostic one.
No
The device description clearly states it is a total knee replacement system composed of physical components (femoral component, tibial insert, tibial base, patella) made from materials like Cobalt Chrome alloy and UHMWPE. It also mentions device-specific instrumentation. This is a hardware medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the MedalOne Total Knee System is for use in knee arthroplasty (surgical replacement of the knee joint) to address conditions like osteoarthritis, rheumatoid arthritis, and fractures. This is a surgical implant, not a device used to examine specimens from the human body.
- Device Description: The description details the components of the knee replacement system (femoral component, tibial insert, tibial base, patella) and their materials. These are physical implants designed to replace parts of the knee joint.
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze biological samples (blood, urine, tissue, etc.) or to provide diagnostic information based on such analysis.
IVD devices are used in vitro (outside the body) to examine specimens and provide information for diagnosis, monitoring, or screening. The MedalOne Total Knee System is an in vivo (inside the body) surgical implant.
N/A
Intended Use / Indications for Use
The MedalOne Total Knee System is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions:
noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or 1) avascular necrosis;
- 2) inflammatory degenerative joint disease including rheumatoid arthritis;
-
- correction of functional deformity:
revision procedures where other treatments or devices have failed: and treatment of fractures 4) that are unmanageable using other techniques.
The MedalOne Total Knee System is for cemented use only.
- correction of functional deformity:
Product codes
JWH, HRY
Device Description
The subject device, MedalOne Total Knee System, is intended for reduction or relief of pain and/or improved knee function. The subject device is a total knee replacement system composed of four different component types: MedalOne Femoral Component, MedalOne CS Tibial Insert, MedalOne Tibial Base and SoSuperior Patella.
The subject system is based on, and substantially equivalent to, the predicate EVOLUTION® MP Total Knee System in terms of size availability, geometry, nominal dimensions, manufacturing tolerances, overall device processing steps, and materials of construction. The articulation adheres to the same "Medial-Pivot" philosophy as the predicate device. The femoral components are made from Cobalt Chrome alloy conforming to ISO 5832-4 and are offered in sizes 1-8 in left and right variants. The tibial inserts are made from standard UHMWPE conforming to ISO 5834-2 and are available in sizes 1-8 in standard and "extended" versions with thickness options of 10, 12, 14, 17, 20, and 24mm. The tibial bases are made from Cobalt Chrome alloy conforming to ISO 5832-4 and are available in 8 standard sizes and 3 plus sizes to permit 1-up/1-down size interchangeability. The patellas are made from UHMWPE conforming to ISO 5834-2 and are offered in a tri-peg design in 4 sizes: 26, 29, 32, and 35mm. The system is intended to be used with bone cement for fixation.
The system also includes device-specific instrumentation to facilitate implantation of the subject devices. The instrument system includes new MedalOne instrumentation and is fully compatible with the predicate Evolution instrumentation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee
Indicated Patient Age Range
skeletally mature patients
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)
Non-clinical testing was performed to support the performance of the subject device and for the determination of substantial equivalence.
This testing included:
- Tibial baseplate fatigue strength evaluation per ISO 14789-1:2000
- MRI safety evaluation per ASTM F2182-19 and FDA Guidance for "Assessment of Radiofrequency-Induced Heating in the Magnetic Resonance (MR) Environment for Multi-Configuration Passive Medical Devices" issued March 2016, ASTM F2182-11a, ASTM F2181-11, ASTM F2052-15, ASTM F2213-17, and ASTM F2119-07 (reapproved 2013)
- Biocompatibility testing per ISO 10993-1 (2018), ISO 10993-5 (2009), ISO 10993-10 -(2014), ISO 10993-11 (2017), ISO/TS 21726 (2019), and FDA Guidance: Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" (September 8, 2023)
- Endotoxin Testing
The nonclinical performance testing results demonstrate that the device is as safe and effective and performs as well or better than the legally marketed predicate and reference devices.
Clinical data were not provided and not necessary to support the substantial equivalence of subject device with the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
EVOLUTION® MP Total Knee System, K093552
Reference Device(s)
EVOLUTION® MP Total Knee System, K102380, ADVANCE® All-Poly Onlay 3-Peg Patella, K953439, ADVANCE® Total Knee System-Patella, K122218
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
February 28, 2025
Suzhou MicroPort OrthoRecon Co., Ltd. Yuiian Mao Quality & RA Senior Director Building 2 and 3, NO.151, Fengli Street, Suzhou Industrial Park Pilot Free Trade Zone Suzhou District Suzhou, Jiangsu 215000 China
Re: K244039
Trade/Device Name: MedalOne 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, HRY Dated: December 12, 2024 Received: December 30, 2024
Dear Yujian Mao:
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 (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 available 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
1
Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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
2
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,
Lixin Liu-S
Lixin Liu, Ph.D 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
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Indications for Use
Submission Number (if known)
Device Name
MedalOne Total Knee System
Indications for Use (Describe)
The MedalOne Total Knee System is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions:
noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or 1) avascular necrosis;
-
- inflammatory degenerative joint disease including rheumatoid arthritis;
-
- correction of functional deformity:
revision procedures where other treatments or devices have failed: and treatment of fractures 4) that are unmanageable using other techniques.
The MedalOne Total Knee System is for cemented use 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)
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Image /page/4/Picture/1 description: The image contains the logo for MicroPort Orthopedics. The logo features a blue square with rounded corners, inside of which is a white circle containing a red diamond shape. To the right of the square is the text "MicroPort" in a large, bold, blue font, with the letters "TM" in a smaller font in the upper right corner. Below the company name is the company's name in Chinese.
MedalOne Total Knee System Traditional 510(k)
510(k) Summary
In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807.92, this information serves as a Summary of Safety and Effectiveness for the use of MedalOne Total Knee System.
| Submitted by: | Suzhou MicroPort OrthoRecon Co., Ltd. |
|---|---|
| Building 2 and 3, NO.151, Fengli Street, Suzhou Industrial | |
| Park China (Jiangsu) Pilot Free Trade Zone Suzhou District, | |
| 215000 Suzhou, Jiangsu, China | |
| Phone: 86-0512-65001777 | |
| Date: | January 17, 2025 |
| Contact Person: | Qingling Bao |
| Proprietary Name: | MedalOne Total Knee System |
| Common Name: | Total Knee System |
| Classification Name and Reference: | Knee joint Patellofemorotibial Polymer/Metal/Polymer Semi- Constrained Cemented Prosthesis, Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis Class II |
| Regulation Number: | 21 CFR 888.3560, 21 CFR 888.3530 |
| Review Panel and Subject Product Code: | Orthopedics/87/JWH, HRY |
| Predicate Device: | EVOLUTION® MP Total Knee System, K093552 |
| Reference Devices: | EVOLUTION® MP Total Knee System, K102380 |
| ADVANCE® All-Poly Onlay 3-Peg Patella, K953439 | |
| ADVANCE® Total Knee System-Patella, K122218 |
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Image /page/5/Picture/1 description: The image contains the logo for MicroPort. The logo consists of a blue square with rounded corners, inside of which is a white circle containing a red star. To the right of the square is the text "MicroPort" in blue, with the letters "TM" in a smaller font size in the upper right corner. Below the text "MicroPort" is Chinese text in blue.
Device Description Summary
The subject device, MedalOne Total Knee System, is intended for reduction or relief of pain and/or improved knee function. The subject device is a total knee replacement system composed of four different component types: MedalOne Femoral Component, MedalOne CS Tibial Insert, MedalOne Tibial Base and SoSuperior Patella.
The subject system is based on, and substantially equivalent to, the predicate EVOLUTION® MP Total Knee System in terms of size availability, geometry, nominal dimensions, manufacturing tolerances, overall device processing steps, and materials of construction. The articulation adheres to the same "Medial-Pivot" philosophy as the predicate device. The femoral components are made from Cobalt Chrome alloy conforming to ISO 5832-4 and are offered in sizes 1-8 in left and right variants. The tibial inserts are made from standard UHMWPE conforming to ISO 5834-2 and are available in sizes 1-8 in standard and "extended" versions with thickness options of 10, 12, 14, 17, 20, and 24mm. The tibial bases are made from Cobalt Chrome alloy conforming to ISO 5832-4 and are available in 8 standard sizes and 3 plus sizes to permit 1-up/1-down size interchangeability. The patellas are made from UHMWPE conforming to ISO 5834-2 and are offered in a tri-peg design in 4 sizes: 26, 29, 32, and 35mm. The system is intended to be used with bone cement for fixation.
The system also includes device-specific instrumentation to facilitate implantation of the subject devices. The instrument system includes new MedalOne instrumentation and is fully compatible with the predicate Evolution instrumentation.
Intended Use/Indication for Use
The MedalOne Total Knee System is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions:
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Image /page/6/Picture/1 description: The image contains the logo for MicroPort. The logo consists of a blue square with rounded corners, inside of which is a white circle containing a red diamond shape. To the right of the square is the text "MicroPort" in blue, with the trademark symbol in the upper right corner. Below the company name is the company's name in Chinese.
-
Noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis;
-
Inflammatory degenerative joint disease including rheumatoid arthritis;
-
Correction of functional deformity;
-
Revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques.
The MedalOne Total Knee System is for cemented use only.
Indication for Use Comparison
Subject indications for use are the same as the predicate.
Technological Comparison
The indications for use, intended patient population, and fundamental scientific technology of the subject devices are identical to the primary and other predicate devices. The design features of the subject devices are substantially equivalent to those of the predicate devices and do not create any new worst-case scenarios. The difference in technological characteristics of the devices does not raise different questions of safety and effectiveness. The substantial equivalence is supported through bench testing results provided in the scope of this application.
The safety and effectiveness of the subject devices are adequately supported by the substantial equivalence information, materials information, and analysis data provided within this premarket notification submission.
Non-Clinical and/or Clinical Tests Summary & Conclusions
The following nonclinical testing was performed to support the performance of the subject device and was used as a basis for the determination of substantial equivalence:
- Tibial baseplate fatigue strength evaluation per ISO 14789-1:2000 -
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Image /page/7/Picture/1 description: The image shows the logo for MicroPort Orthopedics. The logo consists of a blue square with rounded corners, inside of which is a white circle containing a red star. To the right of the square is the word "MicroPort" in blue, with the letters "TM" in a smaller font size in the upper right corner. Below the word "MicroPort" is some Chinese text in blue.
- MRI safety evaluation per ASTM F2182-19 and FDA Guidance for "Assessment of Radiofrequency-Induced Heating in the Magnetic Resonance (MR) Environment for Multi-Configuration Passive Medical Devices" issued March 2016, ASTM F2182-11a, ASTM F2181-11, ASTM F2052-15, ASTM F2213-17, and ASTM F2119-07 (reapproved 2013)
- Biocompatibility testing per ISO 10993-1 (2018), ISO 10993-5 (2009), ISO 10993-10 -(2014), ISO 10993-11 (2017), ISO/TS 21726 (2019), and FDA Guidance: Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" (September 8, 2023)
- Endotoxin Testing -
The following analyses were leveraged based on substantial equivalence to the predicate device:
- Range of motion evaluation -
- -Femorotibial and patellofemoral contact area and stability evaluation
- -Component lock detail evaluation
- UHWMPE Material Property Characterization -
- -Durability of the Patellofemoral Joint
- UHMWPE Tibial Insert Endurance and Deformation Under High Flexion -
- -Fatigue Strength of Knee Femoral Components
Justification was provided for not completing wear testing of the tibial bearing components.
Clinical data were not provided and not necessary to support the substantial equivalence of subject device with the predicate device.
The nonclinical performance testing results demonstrate that the device is as safe and effective and performs as well or better than the legally marketed predicate and reference devices.