· 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.

Device Description

The tibial bearing is made from Vitamin E blended UHMWPE and is available in 6 sizes, ranging from 8-14mm in thickness. The design is symmetrical and may be used for either the medial or lateral compartment of the left or right knee in unicompartmental arthroplasty as part of the Arthrex iBalance UKA System.

AI/ML Overview

This document describes the Arthrex iBalance UKA System Vitamin E Tibial Bearing, a medical device. The document is a 510(k) summary, which is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device.

Here's the breakdown of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

| Acceptance Criteria | Reported Device Performance |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| For Shear Interlock: The maximum moment force meets the acceptance criteria established in the predicate 510(k). This implies a quantitative or qualitative threshold for the maximum moment force the device can withstand without failure or unacceptable deformation, ensuring mechanical integrity. | Shear interlock testing was conducted on the proposed Vitamin E blended UHMWPE tibial bearing to demonstrate that the maximum moment force meets the acceptance criteria established in the predicate 510(k). (The specific numerical value of the acceptance criteria and the measured maximum moment force are not provided in this summary but are stated to have been met.) |
| For Pyrogenicity: The device meets pyrogen limit specifications as determined by Bacterial endotoxin per EP 2.6.14/USP <85>. This indicates that the level of bacterial endotoxins (pyrogens) is below a predefined threshold, ensuring the device is safe for implantation and will not cause fever or other adverse pyrogenic reactions. | Bacterial endotoxin per EP 2.6.14/USP <85> was conducted to demonstrate that the device meets pyrogen limit specifications. (The specific numerical pyrogen limit and the measured endotoxin levels are not provided but are stated to have been met.) |

Note: The document states that the Vitamin E material has been previously cleared under K153586 (Arthrex iBalance TKA System), implying that the material itself has met various other safety and performance criteria in that previous submission, such as biocompatibility, wear resistance, and mechanical properties. However, these specific criteria and their performance are not detailed in this 510(k) summary for the UKA system.

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not explicitly stated for either test. The description mentions "Shear interlock testing was conducted" and "Bacterial endotoxin per EP 2.6.14/USP <85> was conducted," implying that a sufficient number of samples were tested to demonstrate compliance, but the exact number is not provided.
Data Provenance: The studies were conducted by Arthrex, Inc. as part of a premarket notification to the FDA. The provenance of the data is internal to the manufacturer's testing processes to support substantial equivalence. The document does not specify country of origin for the data (beyond Arthrex being based in Naples, FL, USA), and the tests are inherently prospective for the purpose of demonstrating device performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The described tests (shear interlock and bacterial endotoxin) are objective physical and chemical tests, not subjective assessments requiring expert interpretation for ground truth.

4. Adjudication method for the test set

Not applicable. As noted above, these are objective physical and chemical tests.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a physical knee implant, not an AI-powered diagnostic or decision support system.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a physical knee implant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the shear interlock test, the "ground truth" is a predetermined acceptance criterion for maximum moment force, derived from regulatory standards, internal specifications, or benchmarks set by the predicate device. For the bacterial endotoxin test, the "ground truth" is the pyrogen limit specification defined by EP 2.6.14/USP <85> standards. These are objective, measurable thresholds.

8. The sample size for the training set

Not applicable. There is no concept of a "training set" for physical device performance tests like mechanical strength or pyrogenicity.

9. How the ground truth for the training set was established

Not applicable. As there is no training set for these types of tests, there is no corresponding establishment of ground truth for a training set.

Summary

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 15, 2016

Arthrex, Inc. David Rogers Regulatory Affairs Project Manager 1370 Creekside Boulevard Naples, Florida 34108-1945

Re: K161060

Trade/Device Name: Arthrex iBalance UKA System Vitamin E Tibial Bearing Regulation Number: 21 CFR 888.3520 Regulation Name: Knee joint femorotibial metal/polymer non-constrained cemented prosthesis Regulatory Class: Class II Product Code: HSX, OIY Dated: November 22, 2016 Received: November 23, 2016

Dear David Rogers:

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

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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 yours,

Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K161060

Device Name

Arthex iBalance UKA System Vitamin E Tibial Bearing

Indications for Use (Describe)

The Arthrex iBalance UKA System components are 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.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

] Over-The-Counter Use (21 CFR 801 Subpart C)

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510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

Date Summary Prepared	December 5, 2016
Manufacturer/Distributor/Sponsor	Arthrex, Inc.1370 Creekside BoulevardNaples, FL 34108-1945 USA
510(k) Contact	David L RogersProject Manager, Regulatory AffairsArthrex, Inc.1370 Creekside BoulevardNaples, FL 34108-1945 USATelephone: 239/643.5553, ext. 71924Fax: 239/598.5508Email: david.rogers@arthrex.com
Trade Name	Arthrex iBalance UKA System Vitamin E Tibial Bearing
Common Name	Unicompartmental Knee System
Primary Product Code -Classification NameCFR	HSXProsthesis, Knee, Femorotibial, Non-Constrained, Metal/Polymer21 CFR 888.3520
Secondary Product Code -Classification NameCFR	OIYProsthesis, Knee, Patellofemorotibial, Semi-Constrained,Cemented, Polymer + Additive/Metal/Polymer + Additive21 CFR 888.3560
Predicate Device	K060670: Accin UNI-Knee System
Reference Predicate Device	K153586: Arthrex iBalance TKA System
Purpose of Submission	This special 510(k) premarket notification is submitted to obtainclearance for a line extension to the Arthrex iBalance UKASystem, which would add a Vitamin E blended UHMWPE tibialbearing component.
Device Description	The tibial bearing is made from Vitamin E blended UHMWPE andis available in 6 sizes, ranging from 8-14mm in thickness. Thedesign is symmetrical and may be used for either the medial orlateral compartment of the left or right knee inunicompartmental arthroplasty as part of the Arthrex iBalanceUKA System.
Indications for Use	Arthrex iBalance UKA System components are intended for usein unicompartmental knee arthroplasty as a result of:
	Moderately disabling joint disease of the knee resultingfrom painful osteoarthritis or post traumatic arthritis; Correction of functional deformities; Revision of previous unsuccessful unicompartmentalknee replacement or other procedure; As an alternative to tibial osteotomy in patients withunicompartmental osteoarthritis.
	These components are single use only and are intended forimplantation with bone cement.
Substantial EquivalenceSummary	The proposed Arthrex iBalance UKA System Vitamin E TibialBearing is similar to the predicate device, in which the basicdesign features and intended uses are the same.
	The Vitamin E material used for the tibial bearing has beenpreviously cleared under K153586.
	Shear interlock testing was conducted on the proposed Vitamin Eblended UHMWPE tibial bearing to demonstrate that themaximum moment force meets the acceptance criteriaestablished in the predicate 510(k).
	Bacterial endotoxin per EP 2.6.14/USP <85> was conducted todemonstrate that the device meets pyrogen limit specifications.
	Based on the indication for use, technological characteristics, andthe summary of data submitted, Arthrex, Inc. has determinedthat the Arthrex iBalance UKA System Vitamin E Tibial Bearing issubstantially equivalent to currently marketed predicate devices.

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Regulation Number and Section

§ 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.