Arthrex iBalance TKA System

K153586 · Arthrex, Inc. · MBH · Feb 19, 2016 · Orthopedic

Device Facts

• Record ID: K153586
• Device Name: Arthrex iBalance TKA System
• Applicant: Arthrex, Inc.
• Product Code: MBH · Orthopedic
• Decision Date: Feb 19, 2016
• 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 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).

Device Story

Arthrex iBalance® TKA System is a total knee arthroplasty system consisting of femoral components, tibial trays, tibial bearing components, and patellar components. This submission introduces Vitamin E blended tibial bearing and patellar components to the existing system. Components are available in various sizes and configurations (posteriorly stabilized, cruciate retaining, CR Plus). Femoral components are available in left/right versions and can be cemented or uncemented (porous coated). The system is used by orthopedic surgeons in a clinical/surgical setting to replace damaged knee joints. The implants provide structural support and articulation to restore knee function and stability. Benefits include pain relief and improved mobility for patients with degenerative or post-traumatic joint disease.

Clinical Evidence

Bench testing only. No clinical data was provided. Mechanical testing, including wear, fatigue, and shear testing, was performed to demonstrate that the Vitamin E blended components meet performance requirements and are substantially equivalent to the predicate devices.

Technological Characteristics

Total knee arthroplasty system components including femoral, tibial, and patellar implants. Materials include metal and polymer; subject device adds Vitamin E blended polymer for tibial bearing and patellar components. Available in posteriorly stabilized (PS) and cruciate retaining (CR) configurations. Femoral components available in cemented or uncemented (porous-coated) versions. Single-use, sterile, 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 knee configuration/function, or moderate varus/valgus/flexion deformity with adequate ligamentous function. Also indicated for revision of previous knee 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

• Arthrex iBalance® TKA System (K081127)
• Arthrex iBalance® TKA System (K133854)
• Arthrex iBalance® Patella Implant, Dome (K143047)
• Arthrex iBalance® TKA System (K152252)
• Arthrex iBalance® TKA System (K152382)

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

February 19, 2016

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

Re: K153586 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, OIY Dated: December 27, 2015 Received: December 29, 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

#### K153586

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 style="font-size:10pt"> <b> </b> </span> <span style="font-size:10pt">☑ Prescription Use (Part 21 CFR 801 Subpart D)</span> </div> |
|------------------------------------------------------------------------------------------------------------------------------------------------|
| <div> <span style="font-size:10pt"> <b> </b> </span> <span style="font-size:10pt">☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> </div> |

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## 2.5 510(K) SUMMARY

| Date Summary Prepared | February 3, 2016 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 - | MBH |
| Classification Name | 888.3565: Knee joint patellofemorotibial metal/polymer |
| CFR | porous-coated uncemented prosthesis. |
| Secondary Product Code - | JWH |
| Classification Name | 888.3560: Prosthesis, Knee, Patellofemorotibial, Semi- |
| CFR | Constrained, Cemented, Polymer/Metal/Polymer |
| Tertiary Product Code - | OIY |
| Classification Name | 888.3560: Prosthesis, Knee, Patellofemorotibial, Semi- |
| CFR | Constrained, Cemented, Polymer/Metal/Polymer |
| Predicate Device | K081127: Arthrex iBalance® TKA System<br>K133854: Arthrex iBalance® TKA System<br>K143047: Arthrex iBalance® Patella Implant, Dome<br>K152252: Arthrex iBalance® TKA System<br>K152382: Arthrex iBalance® TKA System |
| Purpose of Submission | This traditional 510(k) premarket notification is<br>submitted to obtain clearance for a line extension to the<br>Arthrex iBalance® TKA System which would add<br>Vitamin E blended tibial bearing components and Vitamin<br>E blended patella components to the 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 |
| | |
| and uncemented (biological fixation) versions and are<br>designed to work with the Arthrex dome patella<br>components. Tibial bearing components are offered in<br>PS, CR and CR Plus configurations. | |
| The proposed Arthrex iBalance® TKA System line<br>extension of this submission adds Vitamin E blended<br>tibial bearing components and Vitamin E blended patella<br>components to the product offering. | |
| The Arthrex iBalance® TKA System is indicated for use<br>Intended Use<br>in individuals undergoing surgery for:<br>Painful, disabling joint disease of the knee resulting<br>●<br>from degenerative arthritis, rheumatoid arthritis or<br>post-traumatic arthritis;<br>Post-traumatic loss of knee joint configuration and<br>●<br>function<br>Moderate varus, valgus, or flexion deformity in which<br>●<br>the ligamentous structures can be returned to adequate<br>function and stability;<br>Revisions of previous unsuccessful knee replacement<br>●<br>or other procedure. | |
| for<br>Additional indications<br>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, with the exception of<br>porous coated femoral components which can be used<br>cemented or uncemented (biological fixation). | |
| The proposed Arthrex iBalance® TKA System adds | |
| Vitamin E blended tibial bearing components and Vitamin | |
| E blended patella components to the existing system. The<br>Arthrex iBalance® TKA System is substantially<br>equivalent to the predicate device as the dimensions,<br>general design, intended use, indications for use,<br>technological characteristics, packaging, storage and<br>sterilization remain the same. Any differences between | |
| | |
| The wear, fatigue and shear testing demonstrates the<br>Arthrex iBalance® TKA System remains in compliance<br>with FDA Guidance and industry standards. | |
| Based on the indication for use, technological<br>characteristics, and the summary of mechanical testing<br>data submitted, Arthrex, Inc. has determined that the<br>Arthrex iBalance® TKA System is substantially<br>equivalent to currently marketed predicate devices. | |

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