Arthrex iBalance UKA System Vitamin E Tibial Bearing

K161060 · Arthrex, Inc. · HSX · Dec 15, 2016 · Orthopedic

Device Facts

• Record ID: K161060
• Device Name: Arthrex iBalance UKA System Vitamin E Tibial Bearing
• Applicant: Arthrex, Inc.
• Product Code: HSX · Orthopedic
• Decision Date: Dec 15, 2016
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3520
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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.

Device Story

The Arthrex iBalance UKA System Vitamin E Tibial Bearing is a prosthetic component for unicompartmental knee arthroplasty. It is manufactured from Vitamin E blended ultra-high-molecular-weight polyethylene (UHMWPE). The device is available in six sizes (8-14mm thickness) and features a symmetrical design suitable for either medial or lateral compartments in either the left or right knee. It is intended for single-use implantation using bone cement. The device is used by orthopedic surgeons in a clinical/surgical setting to replace damaged joint surfaces, aiming to restore knee function and alleviate pain associated with osteoarthritis or post-traumatic arthritis.

Clinical Evidence

Bench testing only. Testing included shear interlock mechanical testing to verify performance against predicate criteria and bacterial endotoxin testing per EP 2.6.14/USP <85> to ensure pyrogen limit compliance.

Technological Characteristics

Material: Vitamin E blended UHMWPE. Design: Symmetrical tibial bearing, 8-14mm thickness. Fixation: Cemented. Sterilization: Not specified. Connectivity: None.

Indications for Use

Indicated for patients with moderately disabling knee joint disease due to osteoarthritis or post-traumatic arthritis, functional deformities, or requiring revision of previous unicompartmental knee replacement. Also indicated as an alternative to tibial osteotomy for unicompartmental osteoarthritis.

Regulatory Classification

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).

Predicate Devices

• Accin UNI-Knee System (K060670)

Reference Devices

• Arthrex iBalance TKA System (K153586)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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/<br>Sponsor | Arthrex, Inc.<br>1370 Creekside Boulevard<br>Naples, FL 34108-1945 USA |
| 510(k) Contact | David L Rogers<br>Project Manager, Regulatory Affairs<br>Arthrex, Inc.<br>1370 Creekside Boulevard<br>Naples, FL 34108-1945 USA<br>Telephone: [phone], ext. 71924<br>Fax: [phone]<br>Email: [e-mail] |
| Trade Name | Arthrex iBalance UKA System Vitamin E Tibial Bearing |
| Common Name | Unicompartmental Knee System |
| Primary Product Code -<br>Classification Name<br>CFR | HSX<br>Prosthesis, Knee, Femorotibial, Non-Constrained, Metal/Polymer<br>21 CFR 888.3520 |
| Secondary Product Code -<br>Classification Name<br>CFR | OIY<br>Prosthesis, Knee, Patellofemorotibial, Semi-Constrained,<br>Cemented, Polymer + Additive/Metal/Polymer + Additive<br>21 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 obtain<br>clearance for a line extension to the Arthrex iBalance UKA<br>System, which would add a Vitamin E blended UHMWPE tibial<br>bearing component. |
| Device Description | The tibial bearing is made from Vitamin E blended UHMWPE and<br>is available in 6 sizes, ranging from 8-14mm in thickness. The<br>design is symmetrical and may be used for either the medial or<br>lateral compartment of the left or right knee in<br>unicompartmental arthroplasty as part of the Arthrex iBalance<br>UKA System. |
| Indications for Use | Arthrex iBalance UKA System components are intended for use<br>in unicompartmental knee arthroplasty as a result of: |
| | Moderately disabling joint disease of the knee resulting<br>from painful osteoarthritis or post traumatic arthritis; Correction of functional deformities; Revision of previous unsuccessful unicompartmental<br>knee replacement or other procedure; As an alternative to tibial osteotomy in patients with<br>unicompartmental osteoarthritis. |
| | These components are single use only and are intended for<br>implantation with bone cement. |
| Substantial Equivalence<br>Summary | The proposed Arthrex iBalance UKA System Vitamin E Tibial<br>Bearing is similar to the predicate device, in which the basic<br>design features and intended uses are the same. |
| | The Vitamin E material used for the tibial bearing has been<br>previously cleared under K153586. |
| | Shear interlock testing was conducted on the proposed Vitamin E<br>blended UHMWPE tibial bearing to demonstrate that the<br>maximum moment force meets the acceptance criteria<br>established in the predicate 510(k). |
| | Bacterial endotoxin per EP 2.6.14/USP <85> was conducted to<br>demonstrate that the device meets pyrogen limit specifications. |
| | Based on the indication for use, technological characteristics, and<br>the summary of data submitted, Arthrex, Inc. has determined<br>that the Arthrex iBalance UKA System Vitamin E Tibial Bearing is<br>substantially equivalent to currently marketed predicate devices. |

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