(25 days)
No
The summary describes a mechanical implant (tibial tray) and its intended use, materials, and performance testing. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML. The performance studies focus on mechanical properties and biocompatibility.
Yes
The device is indicated for use in knee arthroplasty to treat painful osteoarthritis or post-traumatic arthritis, correct functional deformities, and revise unsuccessful knee replacements, all of which are therapeutic interventions.
No
The device is an implantable knee system (iBalance UKA Tibial Tray Implant) used in arthroplasty, which is a treatment for knee joint diseases, not for diagnosing conditions.
No
The device description clearly states it is a "new tibial tray made of the same materials (CoCr) as the predicate," indicating a physical implant, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as an implant for unicompartmental and bicompartmental knee arthroplasty. This is a surgical procedure involving the replacement of damaged knee joint components.
- Device Description: The device is described as a tibial tray implant made of CoCr, designed for implantation with bone cement. This is a physical implant, not a diagnostic tool.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples (like blood, urine, or tissue) or to provide information about a patient's health status through in vitro analysis.
- Performance Studies: The performance studies mentioned (tensile testing, finite element analysis, bacterial endotoxin test, MRI testing) are related to the mechanical properties, safety, and compatibility of the implant, not to diagnostic accuracy.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical implant used to treat a condition, not to diagnose it.
N/A
Intended Use / Indications for Use
The iBalance UKA Tibial Tray Implant is part of the iBalance UKA System, which is indicated for use in unicompartmental knee arthroplasty as a result of:
• Moderately disabling joint disease of the knee resulting from painful osteoarthritis or post traumatic arthritis;
• Correction of functional deformities;
• Revision of previous unsuccessful unicompartmental knee replacement or other procedure;
• As an alternative to tibial osteotomy in patients with unicompartmental osteoarthritis
These components are single use only and are intended for implantation with bone cement.
When used concurrently, the Arthrex iBalance UKA and PFJ systems, create the Arthrex iBalance BiCompartmental Arthroplasty System. The Arthrex iBalance BiCompartmental Arthroplasty System is intended to be used as a multi-compartmental knee arthroplasty in patients with:
• Moderately disabling joint disease of the knee resulting from painful osteoarthritis or post traumatic arthritis;
• Correction of functional deformities;
• Revision of previous unsuccessful partial knee replacement or other procedure.
The BiCompartmental Arthroplasty System is not intended to be used as a dual-condyle or tri-compartmental knee.
These components are single use only and are intended for implantation with bone cement.
Product codes (comma separated list FDA assigned to the subject device)
HSX
Device Description
The proposed device is new tibial tray made of the same materials (CoCr) as the predicate. The proposed tibial tray is offered in six sizes (1-6) and available for the left-medial/right-lateral and right-medial/left-lateral compartments. The proposed device is designed for use with the cleared tibial bearing and femoral implants of the Arthrex iBalance UKA System.
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)
Tensile testing, Finite Element Analysis (ASTM F1800) was performed to demonstrate that the proposed device performs equivalently to the predicate.
Bacterial Endotoxin test was conducted in accordance with ANSI/AAMI ST72:2011/(R)2016, USP , USP , EP 2.6.14 to demonstrate that the proposed device meets pyrogen limit specifications.
MRI testing were conducted in accordance with FDA guidance Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment and ASTM F2182.
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.
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
§ 888.3520 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.
0
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March 17, 2020
Arthrex Inc. Ivette Galmez Senior Regulatory Affairs Specialist 1370 Creekside Boulevard Naples, Florida 34108
Re: K200433
Trade/Device Name: iBalance UKA Tibial Tray Implant 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: February 20, 2020 Received: February 21, 2020
Dear Ivette Galmez:
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 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
1
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 mediation-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
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Indications for Use
510(k) Number (if known) K200433
Device Name iBalance UKA Tibial Tray Implant
Indications for Use (Describe)
The iBalance UKA Tibial Tray Implant is part of the iBalance UKA System, which is indicated for use in unicompartmental knee arthroplasty as a result of:
- Moderately disabling joint disease of the knee resulting from painful osteoarthritis or post traumatic arthritis;
- · Correction of functional deformities:
- · Revision of previous unsuccessful unicompartmental knee replacement or other procedure;
- · As an alternative to tibial osteotomy in patients with unicompartmental osteoarthritis.
These components are single use only and are intended for implantation with bone cement.
When used concurrently, the Arthrex iBalance UKA and PFJ systems, create the Arthrex iBalance BiCompartmental Arthroplasty System. The Arthrex iBalance BiCompartmental Arthroplasty System is intended to be used as a multicompartmental knee arthroplasty in patients with:
- Moderately disabling joint disease of the knee resulting from painful osteoarthritis or post traumatic arthritis;
- Correction of functional deformities;
- Revision of previous unsuccessful partial knee replacement or other procedure.
The BiCompartmental Arthroplasty System is not intended to be used as a dual-condyle or tri-compartmental knee. These components are single use only and are intended for implantation with bone cement.
| 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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| 510(k) Summary | |
|---|---|
| Date Prepared | March 17, 2020 |
| Submitter | Arthrex Inc. |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 | |
| Contact Person | Ivette Galmez |
| Senior Regulatory Affairs Specialist | |
| 1-239-643-5553, ext. 71263 | |
| Ivette.galmez@arthrex.com | |
| Name of Device | iBalance UKA Tibial Tray Implant |
| Common Name | Unicompartmental Knee System |
| Product Code | HSX |
| Classification Name | 21 CFR 888.3520: Knee joint femorotibial metal/polymer non-constrained, cemented |
| prosthesis | |
| Regulatory Class | II |
| Predicate Device | K060670: ACCIN UNI-Knee System |
| K160461: Arthrex iBalance BiCompartmental Arthroplasty System | |
| Reference Device | K171365: Arthrex Knee Systems |
| Purpose of Submission | This Special 510(k) premarket notification is submitted to obtain clearance for a new |
| tibial tray model as a line extension to the Arthrex iBalance UKA System cleared under | |
| K060670. | |
| Device Description | The proposed device is new tibial tray made of the same materials (CoCr) as the |
| predicate. The proposed tibial tray is offered in six sizes (1-6) and available for the left- | |
| medial/right-lateral and right-medial/left-lateral compartments. The proposed device is | |
| designed for use with the cleared tibial bearing and femoral implants of the Arthrex | |
| iBalance UKA System. | |
| Indications for Use | The iBalance UKA Tibial Tray Implant is part of the iBalance UKA System, which is |
| indicated for use in unicompartmental knee arthroplasty as a result of: | |
| • Moderately disabling joint disease of the knee resulting from painful osteoarthritis | |
| or post traumatic arthritis; | |
| • Correction of functional deformities; | |
| • Revision of previous unsuccessful unicompartmental knee replacement or other | |
| procedure; | |
| • As an alternative to tibial osteotomy in patients with unicompartmental | |
| osteoarthritis | |
| These components are single use only and are intended for implantation with bone | |
| cement. | |
| When used concurrently, the Arthrex iBalance UKA and PFJ systems, create the Arthrex | |
| iBalance BiCompartmental Arthroplasty System. The Arthrex iBalance BiCompartmental | |
| Arthroplasty System is intended to be used as a multi-compartmental knee arthroplasty | |
| in patients with: | |
| • Moderately disabling joint disease of the knee resulting from painful osteoarthritis | |
| or post traumatic arthritis; | |
| • Correction of functional deformities; | |
| • Revision of previous unsuccessful partial knee replacement or other procedure. | |
| The BiCompartmental Arthroplasty System is not intended to be used as a dual-condyle | |
| or tri-compartmental knee. | |
| These components are single use only and are intended for implantation with bone | |
| cement. | |
| Comparison Summary | |
| of Technological | |
| Characteristics and | |
| Modifications | |
| Proposed | The proposed device is a line extension to the predicate device. The proposed and |
| predicate devices (K060670) have the same basic design, intended use, indications for | |
| use, shelf life and sterilization method. Proposed modifications consist of dimensional | |
| changes to the A/P length and anterior portion of the implant as well as modification of | |
| the angle of the pegs. The packaging configuration of the proposed device is the same | |
| configuration as K160461. | |
| Any differences between the proposed device and the predicate device are considered | |
| minor and do not raise questions concerning safety or effectiveness. | |
| Performance Data | Tensile testing, Finite Element Analysis (ASTM F1800) was performed to demonstrate |
| that the proposed device performs equivalently to the predicate. | |
| Bacterial Endotoxin test was conducted in accordance with ANSI/AAMI | |
| ST72:2011/(R)2016, USP , USP , EP 2.6.14 to demonstrate that the proposed | |
| device meets pyrogen limit specifications. | |
| MRI testing were conducted in accordance with FDA guidance Testing and Labeling | |
| Medical Devices for Safety in the Magnetic Resonance (MR) Environment and ASTM | |
| F2182. | |
| Conclusion | The iBalance UKA Tibial Tray Implant is substantially equivalent to the predicate device |
| in which the basic design features and intended use are the same. The mechanical | |
| testing data demonstrates that the proposed device performance is equivalent to the | |
| predicate device for the desired indications. Any differences between the proposed | |
| device and the predicate device are considered minor and do not raise questions | |
| regarding safety or effectiveness. | |
| Based on the indications for use, technological characteristics, and the summary of data | |
| submitted, Arthrex Inc. has determined that the proposed device is substantially | |
| equivalent to the currently marketed predicate device. |
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