(25 days)
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.
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.
This document is a 510(k) premarket notification for a medical device: the iBalance UKA Tibial Tray Implant. It is not a study demonstrating the performance of an AI/ML powered device. Therefore, the questions related to AI/ML device acceptance criteria and study methodologies, such as sample sizes for test and training sets, expert qualifications, ground truth establishment, MRMC studies, and standalone performance, cannot be answered from the provided text.
The document primarily focuses on demonstrating the substantial equivalence of a physical medical implant (a knee joint component) to previously cleared predicate devices. The "Performance Data" section in the 510(k) summary refers to mechanical testing (Tensile testing, Finite Element Analysis), bacterial endotoxin testing, and MRI compatibility testing for the implant itself, not the performance of an AI/ML algorithm.
Therefore, the requested information for an AI/ML device's acceptance criteria and study will be stated as "Not applicable" or "Not provided" based on the content of this specific document.
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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
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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 BoulevardNaples, FL 34108-1945 |
| Contact Person | Ivette GalmezSenior Regulatory Affairs Specialist1-239-643-5553, ext. 71263Ivette.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, cementedprosthesis |
| Regulatory Class | II |
| Predicate Device | K060670: ACCIN UNI-Knee SystemK160461: 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 newtibial tray model as a line extension to the Arthrex iBalance UKA System cleared underK060670. |
| Device Description | The proposed device is new tibial tray made of the same materials (CoCr) as thepredicate. 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 isdesigned for use with the cleared tibial bearing and femoral implants of the ArthrexiBalance UKA System. |
| Indications for Use | The iBalance UKA Tibial Tray Implant is part of the iBalance UKA System, which isindicated for use in unicompartmental knee arthroplasty as a result of:• Moderately disabling joint disease of the knee resulting from painful osteoarthritisor post traumatic arthritis;• Correction of functional deformities;• Revision of previous unsuccessful unicompartmental knee replacement or otherprocedure;• As an alternative to tibial osteotomy in patients with unicompartmentalosteoarthritisThese components are single use only and are intended for implantation with bonecement.When used concurrently, the Arthrex iBalance UKA and PFJ systems, create the ArthrexiBalance BiCompartmental Arthroplasty System. The Arthrex iBalance BiCompartmentalArthroplasty System is intended to be used as a multi-compartmental knee arthroplastyin patients with:• Moderately disabling joint disease of the knee resulting from painful osteoarthritisor 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-condyleor tri-compartmental knee.These components are single use only and are intended for implantation with bonecement. |
| Comparison Summaryof TechnologicalCharacteristics andModificationsProposed | The proposed device is a line extension to the predicate device. The proposed andpredicate devices (K060670) have the same basic design, intended use, indications foruse, shelf life and sterilization method. Proposed modifications consist of dimensionalchanges to the A/P length and anterior portion of the implant as well as modification ofthe angle of the pegs. The packaging configuration of the proposed device is the sameconfiguration as K160461.Any differences between the proposed device and the predicate device are consideredminor and do not raise questions concerning safety or effectiveness. |
| Performance Data | Tensile testing, Finite Element Analysis (ASTM F1800) was performed to demonstratethat the proposed device performs equivalently to the predicate.Bacterial Endotoxin test was conducted in accordance with ANSI/AAMIST72:2011/(R)2016, USP <161>, USP <85>, EP 2.6.14 to demonstrate that the proposeddevice meets pyrogen limit specifications.MRI testing were conducted in accordance with FDA guidance Testing and LabelingMedical Devices for Safety in the Magnetic Resonance (MR) Environment and ASTMF2182. |
| Conclusion | The iBalance UKA Tibial Tray Implant is substantially equivalent to the predicate devicein which the basic design features and intended use are the same. The mechanicaltesting data demonstrates that the proposed device performance is equivalent to thepredicate device for the desired indications. Any differences between the proposeddevice and the predicate device are considered minor and do not raise questionsregarding safety or effectiveness.Based on the indications for use, technological characteristics, and the summary of datasubmitted, Arthrex Inc. has determined that the proposed device is substantiallyequivalent to the currently marketed predicate device. |
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§ 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.