ARTHREX IBALANCE TKA SYSTEM

K133854 · Arthrex, Inc. · JWH · Feb 27, 2014 · Orthopedic

Device Facts

• Record ID: K133854
• Device Name: ARTHREX IBALANCE TKA SYSTEM
• Applicant: Arthrex, Inc.
• Product Code: JWH · Orthopedic
• Decision Date: Feb 27, 2014
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Arthrex iBalance® TKA System is indicated for use in individuals undergoing surgery for: • Painful, disabling joint disease of the knee resulting from degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis: • Post-traumatic loss of knee joint configuration and function • Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability: • Revisions of previous unsuccessful knee replacement or other procedure. Additional indications for posteriorly stabilized components: • Ligamentous instability requiring implant bearing surfaces with increased constraint; • Absent or non-functioning posterior cruciate ligament. These devices are single use only and are intended for implantation with bone cement.

Device Story

Arthrex iBalance® TKA System is a total knee arthroplasty prosthesis consisting of femoral components, tibial tray, tibial bearing components, and patellar components. Designed for surgical implantation in patients with knee joint disease or deformity. Femoral and tibial tray components are Cobalt-Chromium alloy; tibial bearing and patellar components are UHMWPE. Available in posteriorly stabilized (PS) and cruciate retaining (CR) configurations. The CR Plus line extension features a modified tibial bearing component with a taller anterior lip. Device is implanted by orthopedic surgeons in an operating room setting using bone cement. System provides mechanical replacement of the knee joint to restore function and stability, reduce pain, and correct deformities. Performance is verified through contact stress, constraint, interlock, and range of motion testing.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing, including contact stress, constraint, interlock, and range of motion testing.

Technological Characteristics

Femoral and tibial tray components: Cobalt-Chromium Alloy (ASTM F-75). Tibial bearing and patellar components: UHMWPE (ASTM F-648). System is a semi-constrained, cemented, patellofemorotibial prosthesis. Available in PS and CR configurations. Single-use.

Indications for Use

Indicated for individuals undergoing knee surgery for painful, disabling joint disease (degenerative, rheumatoid, or post-traumatic arthritis), post-traumatic loss of joint function, or moderate varus/valgus/flexion deformity with stable ligaments. Also indicated for revision of previous knee procedures. Posteriorly stabilized components are indicated for ligamentous instability or absent/non-functioning posterior cruciate ligament. Single use; requires bone cement.

Regulatory Classification

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).

Predicate Devices

• Accin™ Total Knee System (K081127)

Submission Summary (Full Text)

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-FEB 2 7 2014

| Date Summary Prepared | January 19, 2013 |
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| Manufacturer/Distributor/Sponsor | Arthrex, Inc.<br>1370 Creekside Boulevard<br>Naples. FL 34108-1945 USA |
| 510(k) Contact | Leon Brown II, Ph.D.<br>Regulatory Affairs Specialist<br>Arthrex, Inc.<br>1370 Creekside Boulevard<br>Naples, FL 34108-1945 USA<br>Telephone: [phone], ext. 72028<br>Fax: [phone]<br>Email: [e-mail] |
| Trade Name | Arthrex iBalance® TKA System |
| Common Name | Knee Prosthesis |
| Product Code -Classification | JWH |
| Name | 888.3560: Prosthesis, Knee, Patellofemorotibial, Semi- |
| CFR | Constrained. Cemented, Polymer/Metal/Polymer |
| Predicate Device | K081127: Accin™ Total Knee System |
| Purpose of Submission | This special 510(k) premarket notification is submitted to<br>obtain clearance for the CR Plus line extension to the<br>current tibial bearing components of the Arthrex<br>iBalance® TKA System. |
| Device Description | The Arthrex iBalance® TKA System consists of femoral<br>components, tibial tray, tibial bearing components and<br>patellar components. All components are available in a<br>range of sizes to fit varying anatomical requirements.<br>Femoral components and tibial bearing components are<br>available in both posteriorly stabilized (PS) and cruciate<br>retaining (CR) configurations. Femoral components are<br>available in left and right versions and are designed to<br>work with the Arthrex dome patella components. Femoral<br>and tibial tray components are manufactured from Cobalt-<br>Chromium Alloy conforming to ASTM F-75. Tibial<br>bearing and patellar components are manufactured from<br>UHMWPE conforming to ASTM F-648.<br><br>The CR Plus line of tibial bearing components are<br>comparable to the system's current tibial bearing<br>components with the exception of having dimensional<br>specifications modification in order to offer a taller |
| | anterior lip for each size of the tibial bearing component. |
| Intended Use | The Arthrex iBalance® TKA System is indicated for use<br>in individuals undergoing surgery for:<br>• Painful, disabling joint disease of the knee resulting<br>from degenerative arthritis, rheumatoid arthritis or<br>post-traumatic arthritis:<br>• Post-traumatic loss of knee joint configuration and<br>function<br>• Moderate varus, valgus, or flexion deformity in which<br>the ligamentous structures can be returned to adequate<br>function and stability:<br>• Revisions of previous unsuccessful knee replacement<br>or other procedure.<br>Additional indications for posteriorly stabilized<br>components:<br>• Ligamentous instability requiring implant bearing<br>surfaces with increased constraint;<br>• Absent or non-functioning posterior cruciate ligament.<br>These devices are single use only and are intended for<br>implantation with bone cement. |
| Substantial Equivalence<br>Summary | The Arthrex iBalance® TKA System is substantially<br>equivalent to the predicate device in which the basic<br>design features and intended uses are the same. Any<br>differences between the Arthrex iBalance® TKA System<br>and the predicate are considered minor and do not raise<br>questions concerning safety and effectiveness.<br>The predicate Arthrex iBalance® TKA System is a total<br>knee arthroplasty system consisting of femoral<br>components, tibial tray, tibial bearing components and<br>patellar components. The proposed Arthrex iBalance®<br>TKA System consists of the same four components plus a<br>line extension to the currently available tibial bearing<br>components. This line extension is referred to as the CR<br>Plus tibial bearing components. The CR Plus tibial<br>bearing components are equivalent to the currently<br>available predicate tibial bearing components in size<br>range. thickness at the sulci, material, use and<br>performance with the exception that the CR Plus tibial<br>bearing components have a dimensional specifications<br>modification to provide a taller anterior lip to the |

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| The contact stress, constraint, interlock and range of motion testing information submitted demonstrates that there is no significant difference in performance between the proposed and predicate devices. |
| Based on the indication for use, technological characteristics, and the summary of mechanical testing data submitted, Arthrex, Inc. has determined that the Arthrex <i>iBalance®</i> TKA System is substantially equivalent to currently marketed predicate devices. |

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized caduceus, which is a symbol of medicine, with three lines forming the wings. The caduceus is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

10903 New Hampshire A Document Control Center - WO Silver Spring, MD 20993-0007

February 27, 2014

Arthrex, Incorporated Leon Brown II. PhD Regulatory Affairs Specialist 1370 Creekside Boulevard Naples. Florida 34108-1945

Re: K133854

Trade/Device Name: Arthrex iBalance"TKA System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patcllofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: JWH Dated: January 20. 2014 Received: January 23, 2014

Dear Dr. Brown:

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 is 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

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## Page 2 - Leon Brown II, PhD

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/Reportal?roblem/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 Small Manufacturers. International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

# Vincent J. Devlin -S

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

Enclosure

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## 2.5 INDICATIONS FOR USE

### Indications for Use

K133854 510(k) Number (if known):

> Device Name: Arthrex iBalance® TKA System

Indications For Use:

The Arthrex iBalance® TKA System is indicated for use in individuals undergoing surgery for:

- Painful, disabling joint disease of the knee resulting from degenerative . arthritis, rheumatoid arthritis or post-traumatic arthritis;
- Post-traumatic loss of knee joint configuration and function; .
- o Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability;
- Revisions of previous unsuccessful knee replacement or other procedure. . Additional indications for posteriorly stabilization components:
- Ligamentous instability requiring implant bearing surfaces with increased . constraint;
- Absent or non-functioning posterior cruciate ligament. 0

These devices are single use only and are intended for implantation with bone cement.

Prescription Use _ V_ AND/OR Over-The-Counter Use __ (Per 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Image /page/5/Picture/20 description: The image contains text that reads "Casey L. Hanley, Ph.D." above a horizontal line. Below the line, the text reads "Division of Orthopedic Devices". The text is surrounded by a decorative border, giving it a stamp-like appearance.

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