ARTHREX IBALANCE TKA SYSTEM

K141635 · Arthrex, Inc. · MBH · Sep 3, 2014 · Orthopedic

Device Facts

• Record ID: K141635
• Device Name: ARTHREX IBALANCE TKA SYSTEM
• Applicant: Arthrex, Inc.
• Product Code: MBH · Orthopedic
• Decision Date: Sep 3, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3565
• 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, with the exception of porous coated femoral components which can be used cemented or uncemented (biological fixation).

Device Story

Arthrex iBalance® TKA System is a total knee arthroplasty system comprising femoral components, tibial trays, tibial bearing components, and patellar components. This submission introduces BioSync™ femoral components featuring a titanium scaffold porous coating for biological fixation (uncemented) or cemented use. System components are available in various sizes and configurations (posteriorly stabilized or cruciate retaining). Used in orthopedic surgery to replace diseased or damaged knee joints; implanted by surgeons. Provides structural replacement of knee joint surfaces to restore function, stability, and configuration; reduces pain associated with arthritis or deformity. Benefits include improved joint mobility and stability for patients with severe knee pathology.

Clinical Evidence

Bench testing only. Testing included fatigue, biocompatibility, metallurgical, corrosion, microstructure, strength, bonding, and abrasion/ingrowth testing to validate the performance of the new titanium scaffold porous coating.

Technological Characteristics

System components: Cobalt-Chromium alloy (ASTM F-75) for femoral/tibial tray; UHMWPE (ASTM F-648) for bearing/patellar components. Features titanium scaffold porous coating for biological fixation. Available in posteriorly stabilized (PS) and cruciate retaining (CR) configurations. Single-use, implantable device.

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 configuration/function, moderate varus/valgus/flexion deformity with stable ligamentous structures, or revision of previous unsuccessful procedures. Posteriorly stabilized components are indicated for ligamentous instability requiring increased constraint or absent/non-functioning posterior cruciate ligament.

Regulatory Classification

Identification

A knee joint patellofemorotibial metal/polymer porous-coated uncemented 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 is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra high molecular weight polyethylene tibial bearing is rigidly secured to the metal tibial base plate.

Special Controls

*Classification.* Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.” See § 888.1 for the availability of this guidance.

Predicate Devices

• Accin™ Total Knee System (K081127)
• Zimmer® Persona™ Personalized Knee System (K121771)

Submission Summary (Full Text)

{0}------------------------------------------------

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 border 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, resembling a bird-like shape.

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

September 3, 2014

Arthrex, Incorporated Mr. Leon Brown II, Ph.D. Regulatory Affairs Specialist 1370 Creekside Boulevard Naples, FL 34108-1945

Re: K141635 Trade/Device Name: Arthrex iBalance® TKA System Regulation Number: 21CFR 888.3565 Regulation Name: Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: MBH, JWH Dated: June 12, 2014 Received: June 19, 2014

Dear Mr. 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'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

{1}------------------------------------------------

(21 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 (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/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/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,

## Lori A. Wiggins -S

for

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

Enclosure

{2}------------------------------------------------

## Indications for Use

510(k) Number (if known) K141635

Device Name

Arthrex iBalance® TKA System

#### Indications for Use (Describe)

- 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 stabilization 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 the exception of porous coated femoral components which can be used cemented (biological fixation).

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

## PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995,

### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

# 2.6 510(K) SUMMARY

| Date Summary Prepared | August 28, 2014 |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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, MBH |
| Name | 888.3565: Knee joint patellofemorotibial metal/polymer |
| CFR | 888.3565: Knee joint patellofemorotibial metal/polymer<br>porous-coated uncemented prosthesis.<br>888.3560: Prosthesis, Knee, Patellofemorotibial, Semi-<br>Constrained, Cemented, Polymer/Metal/Polymer |
| Predicate Device | K081127: Accin™ Total Knee System<br>K121771: Zimmer® Persona™ Personalized Knee System |
| Purpose of Submission | This <b>traditional</b> 510(k) premarket notification is<br>submitted to obtain clearance for the Arthrex iBalance®<br>BioSync™ Femoral Components line extension to the<br>current Arthrex 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>The Arthrex iBalance® BioSync™ Femoral Components |
| | line offers the option of affixing the system's femoral<br>components without cement through the use of a titanium<br>scaffold porous coating (biological fixation). |
| <i>Intended Use</i> | The <i>Arthrex iBalance® TKA System</i> 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;Post-traumatic loss of knee joint configuration and<br>functionModerate varus, valgus, or flexion deformity in which<br>the ligamentous structures can be returned to adequate<br>function and stability;Revisions of previous unsuccessful knee replacement<br>or other procedure.Additional indications for posteriorly stabilized<br>components:<br>Ligamentous instability requiring implant bearing<br>surfaces with increased constraint;Absent or non-functioning posterior cruciate ligament.These devices are single use only and are intended for<br>implantation with bone cement, with the exception of<br>porous coated femoral components which can be used<br>cemented or uncemented (biological fixation). |
| <i>Substantial Equivalence Summary</i> | The <i>Arthrex iBalance® TKA System</i> 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 <i>Arthrex iBalance® TKA System</i><br>and the predicate are considered minor and do not raise<br>questions concerning safety and effectiveness.<br><br>The predicate <i>Arthrex iBalance® TKA System</i> is a total<br>knee arthroplasty system consisting of femoral<br>components, tibial tray, tibial bearing components and<br>patellar components. The proposed <i>Arthrex iBalance®<br/>TKA System</i> consists of the same four components plus a<br>line extension to the currently available femoral<br>components. This Arthrex iBalance® BioSync™ Femoral<br>Components line extension is equivalent to the currently<br>available Arthrex predicate femoral components in size<br>range, material use and performance with the exception |
| that the Arthrex iBalance® BioSync™ Femoral<br>Components have a titanium scaffold porous coating or<br>their non-articulating side. | |
| There have been no changes to the articulating surfaces of<br>the femoral components. Fatigue, biocompatibility,<br>metallurgical, corrosion, microstructure, strength,<br>bonding, abrasion and ingrowth testing information<br>submitted demonstrates that the Arthrex iBalance®<br>BioSync™ Femoral Components are consistent with FDA<br>Guidance regarding porous coated orthopedic implants. | |
| Based on the indication for use, technological<br>characteristics, and testing data submitted, Arthrex, Inc.<br>has determined that the Arthrex iBalance® TKA System<br>is substantially equivalent to currently marketed predicate<br>devices. | |

{4}------------------------------------------------

{5}------------------------------------------------