Arthrex iBalance TKA System

K152252 · Arthrex, Inc. · MBH · Nov 16, 2015 · Orthopedic

Device Facts

• Record ID: K152252
• Device Name: Arthrex iBalance TKA System
• Applicant: Arthrex, Inc.
• Product Code: MBH · Orthopedic
• Decision Date: Nov 16, 2015
• 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

Total knee arthroplasty (TKA) system comprising femoral components, tibial trays, tibial bearing components, and patellar components. Designed for surgical implantation to replace diseased or damaged knee joints. Femoral and tibial tray components manufactured from cobalt-chromium alloy or titanium alloy; bearing and patellar components from UHMWPE. System offers posteriorly stabilized (PS) and cruciate retaining (CR) configurations. Line extension introduces modular tibial trays with options for stem extensions and tibial augments, plus expanded size range (sizes 1-10). Used by orthopedic surgeons in clinical/OR settings to restore joint function and stability. Benefits include pain relief and improved mobility for patients with severe knee joint pathology.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included fatigue, wear, interlock, and assembly/disassembly evaluations to demonstrate performance equivalence.

Technological Characteristics

Materials: Cobalt-chromium alloy (ASTM F75), titanium alloy (ASTM F136), UHMWPE (ASTM F648). Components: Femoral, tibial tray, tibial bearing, patellar. Configurations: PS and CR. Modular features: Stem extensions, tibial augments. Fixation: Cemented or uncemented (porous coated). Single-use.

Indications for Use

Indicated for individuals with painful, disabling knee joint disease (degenerative, rheumatoid, or post-traumatic arthritis), post-traumatic loss of joint configuration/function, or moderate varus/valgus/flexion deformity requiring ligamentous stability. Also indicated for revision of unsuccessful knee procedures. Posteriorly stabilized components indicated for ligamentous instability 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

• AccinTM Total Knee System (K081127)
• Zimmer® PersonaTM Knee System (K122765)

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

November 16, 2015

Arthrex, Incorporated Leon Brown II, Ph.D. Regulatory Project Manager 1370 Creekside Boulevard Naples, Florida 34108-1945

Re: K152252

Trade/Device Name: Arthrex iBalance® TKA System Regulation Number: 21 CFR 888.3565 Regulation Name: Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: MBH, JWH Dated: September 22, 2015 Received: September 23, 2015

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'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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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 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" (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,

# 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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Expiration Date: January 31, 2017

See PRA Statement below

### Indications for Use

510(k) Number (if known)

K152252

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) | |
|-----------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|
| <div> <span> <b> ☑ </b> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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## 2.6 510(K) SUMMARY

| Date Summary Prepared | November 10, 2015 |
|---------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 Project Manager<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 |
| Primary Product Code -<br>Classification Name<br><i>CFR</i> | MBH<br>888.3565: Knee joint patellofemorotibial metal/polymer<br>porous-coated uncemented prosthesis. |
| Secondary Product Code -<br>Classification Name<br><i>CFR</i> | JWH<br>888.3560: Prosthesis, Knee, Patellofemorotibial, Semi-<br>Constrained, Cemented, Polymer/Metal/Polymer |
| Predicate Device | K081127: AccinTM Total Knee System<br>K122765: Zimmer® PersonaTM Knee System |
| Purpose of Submission | This <b>traditional</b> 510(k) premarket notification is<br>submitted to obtain clearance for the Arthrex iBalance®<br>Modular Tibial Tray line extension to the current 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, as well as cemented<br>and uncemented (biological fixation) versions and are<br>designed to work with the Arthrex dome patella<br>components. Femoral and tibial tray components are<br>manufactured from either cobalt-chromium alloy<br>conforming to ASTM F75 or titanium alloy conforming to<br>ASTM F136. Tibial bearing and patellar components are<br>manufactured from UHMWPE conforming to ASTM |
| | F648. |
| | The Arthrex iBalance® Modular Tibial Tray line<br>extension offers the option of using stem extensions<br>and/or tibial augments in a tray manufactured from<br>titanium alloy. The Arthrex iBalance® Modular Tibial<br>Tray would have two additional larger sizes—coming in<br>sizes 1-10 rather than the size 1-8 range of the predicate.<br>Two additional larger sized tibial bearing components and<br>femoral components, size 9 & size 10, are also being<br>offered. |
| 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; Post-traumatic loss of knee joint configuration and<br>function Moderate 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: 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). |
| 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><br>The predicate Arthrex iBalance® TKA System is a total<br>knee arthroplasty system consisting of femoral |
| | |
| components, tibial tray, tibial bearing components and | |
| patellar components. The proposed Arthrex iBalance® | |
| TKA System consists of the same four components plus a | |
| line extension to the currently available tibial trays. This | |
| Arthrex iBalance® Modular Tibial Tray line extension is | |
| equivalent to the currently available Arthrex predicate | |
| tibial trays in size range, use and performance, with the | |
| exception that the Arthrex iBalance® Modular Tibial Tray | |
| line extension offers the option of using stem extensions | |
| and/or tibial augments in a tray manufactured from | |
| titanium alloy. | |
| | |
| Fatigue, wear, interlock and assembly/disassembly testing | |
| demonstrates Arthrex iBalance® Modular Tibial Tray | |
| compliance with FDA Guidance and industry standards. | |
| | |
| on the indication for use, technological<br>Based | |
| characteristics, and testing data submitted, Arthrex, Inc. | |
| has determined that the Arthrex iBalance® TKA System | |
| is substantially equivalent to currently marketed predicate | |
| devices. | |
| | |

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