Arthrex Knee Systems

K171365 · Arthrex, Inc. · MBH · Nov 7, 2017 · Orthopedic

Device Facts

• Record ID: K171365
• Device Name: Arthrex Knee Systems
• Applicant: Arthrex, Inc.
• Product Code: MBH · Orthopedic
• Decision Date: Nov 7, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3565
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Arthrex iBalance BiCompartmental Arthroplasty System is intended to be used as a multicompartmental knee arthroplasty in patients with: - Moderately disabling joint disease of the knee resulting from painful osteoarthritis or post traumatic arthritis; - Correction of functional deformities; - Revision of previous unsuccessful partial knee replacement or other procedure; The BiCompartmental Arthroplasty System is not intended to be used as a dual-condyle or tri-compartmental knee. These components are single use only and are intended for implantation with bone cement. The Arthrex iBalance PFJ components are intended for use in patellofemoral knee arthroplasty in patients with: - Degenerative arthritis in the distal femur and patella; - A history of patellar dislocation or fracture; - Failed previous surgery (arthroscopy, tibial tubercle elevation, lateral release) where pain, deformity or dysfunction persists. These components are single use only and are intended for implantation with bone cement. 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, rheumatic 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 the exception of porous coated femoral components which can be used cemented (biological fixation). Arthrex iBalance UKA System is intended 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

Arthrex Knee Systems (TKA, UKA, PFJ, BiCompartmental) are orthopedic implants consisting of femoral, tibial, and patellar components. Used by orthopedic surgeons in clinical settings to replace damaged knee joint surfaces. Implants are fixed via bone cement or biological fixation (porous-coated femoral components). This submission updates labeling to include 'MR Conditional' status per FDA guidance. Device provides structural replacement for diseased or deformed knee joints, aiming to restore function and reduce pain. No software or algorithmic processing involved.

Clinical Evidence

No clinical data provided. Evidence consists of non-clinical bench testing and in-vivo electromagnetic simulation to establish 'MR Conditional' status per FDA guidance, and bacterial endotoxin testing per EP 2.6.14/USP <85>.

Technological Characteristics

Passive orthopedic implants (femoral, tibial, patellar components). Materials include metal and polymer. Fixation via bone cement or biological fixation (porous-coated). MR Conditional status established via electromagnetic simulation. Single-use.

Indications for Use

Indicated for patients with painful, disabling knee joint disease (osteoarthritis, rheumatoid arthritis, post-traumatic arthritis), functional deformities, history of patellar dislocation/fracture, or failed prior knee surgeries requiring revision. Specific indications vary by system (TKA, UKA, PFJ, BiCompartmental) regarding ligamentous stability and compartment involvement.

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 UKA System Vitamin E Tibial Bearing (K161060)
• Arthrex iBalance BiCompartmental Arthroplasty System (K160461)
• Arthrex iBalance TKA System (K153586)
• Arthrex iBalance TKA System (K152382)
• Arthrex iBalance TKA System (K152252)
• Arthrex iBalance Patella Implant, Dome (K143047)
• Arthrex iBalance TKA System (K133854)
• ACCIN Patellafemoral System (K073120)
• ACCIN UNI-Knee System (K063782)
• ACCIN UNI-Knee System (K060670)

Submission Summary (Full Text)

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November 7, 2017

Arthrex Inc. David L. Rogers Project Manager, Regulatory Affairs 1370 Creekside Boulevard Naples, Florida 34108-1945

Re: K171365

Trade/Device Name: Arthrex Knee Systems Regulation Number: 21 CFR 888.3565 Regulation Name: Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: MBH, HSX, KRR Dated: October 3, 2017 Received: October 11, 2017

Dear Mr. 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 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);

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### Page 2 - Mr. David Rogers

and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# 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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### Indications for Use

510(k) Number (if known)

K171365

Device Name

Arthrex iBalance BiCompartmental Arthoplasty System

Indications for Use (Describe)

When used concurrently, the Arthrex iBalance UKA and PFJ systems create the Arthrex iBalance BiCompartmental Arthroplasty System. The Arthrex iBalance BiCompartmental Arthroplasty System is intended to be used as a multicompartmental knee arthroplasty in patients with:

- Moderately disabling joint disease of the knee resulting from painful osteoarthritis or post traumatic arthritis;
- · Correction of functional deformities;
- · Revision of previous unsuccessful partial knee replacement or other procedure;

The BiCompartmental Arthroplasty System is not intended to be used as a dual-condyle or tri-compartmental knee.

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

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

| <span style="font-family: sans-serif;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|----------------------------------------------------------------------------------------------|-----------------------------------------------|
|----------------------------------------------------------------------------------------------|-----------------------------------------------|

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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

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

### Indications for Use

510(k) Number (if known)

K171365

Device Name Arthrex iBalance PFJ

### Indications for Use (Describe)

The Arthrex iBalance PFJ components are intended for use in patellofemoral knee arthroplasty in patients with:

- · Degenerative arthritis in the distal femur and patella;
- · A history of patellar dislocation or fracture;
- Failed previous surgery (arthroscopy, tibial tubercle elevation, lateral release) where pain, deformity or dysfunction persists.

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

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

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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 [e-mail]

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

### Indications for Use

510(k) Number (if known)

#### K171365

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

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

| <span> <b>X</b> Prescription Use (Part 21 CER 801 Subpart D) </span> |
|------------------------------------------------------------------------|
| <span>Over-The-Counter Use (21 CER 801 Subpart C)</span> |

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

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

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

### Indications for Use

510(k) Number (if known) K171365

Device Name Arthrex iBalance UKA System

#### Indications for Use (Describe)

Arthrex iBalance UKA System is intended 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) | |
|-----------------------------------------------------------------------------------------|-----------------------------------------------|
| <span style="font-family: Arial;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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 [e-mail]

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## 510(k) Summary or 510(k) Statement

| Date Prepared | May 5, 2017 |
|--------------------------|-------------------------------------------------------------------------------------|
| Submitter | Arthrex Inc. |
| | 1370 Creekside Boulevard |
| | Naples, FL 34108-1945 |
| Contact Person | David L Rogers |
| | Project Manager, Regulatory Affairs |
| | 1-239-643-5553, ext. 71924 |
| | [e-mail] |
| Name of Device | Arthrex Knee Systems |
| Common Name | Knee Prosthesis |
| Product Code | MBH, HSX, KRR |
| Classification Name | 21 CFR 888.3565: Knee joint patellofemorotibial metal/polymer porous-coated |
| | uncemented prosthesis |
| | 21 CFR 888.3560: Prosthesis, Knee, Patellofermorotibial, Semi-Constrained, |
| | Cemented, Polymer/Metal/Polymer |
| | 21 CFR 888.3520: Prosthesis, Knee, Femorotibial, Non-Constrained, |
| | Metal/Polymer |
| Regulatory Class | II |
| Predicate Device | K161060: Arthrex iBalance UKA System Vitamin E Tibial Bearing |
| | K160461: Arthrex iBalance BiCompartmental Arthroplasty System |
| | K153586: Arthrex iBalance TKA System |
| | K152382: Arthrex iBalance TKA System |
| | K152252: Arthrex iBalance TKA System |
| | K143047: Arthrex iBalance Patella Implant, Dome |
| | K133854: Arthrex iBalance TKA System |
| | K073120: ACCIN Patellafemoral System |
| | K063782: ACCIN UNI-Knee System |
| | K060670: ACCIN UNI-Knee System |
| Purpose of<br>Submission | This Special 510(k) premarket notification is submitted to obtain clearance for the |
| | modification to the device labeling for the Arthrex Knee Systems to include the |
| | "MR Conditional" statement in accordance with the FDA Guidance, "Establishing |
| | Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) |
| | Environment". |
| Device Description | The Arthrex Knee Systems encompass the following FDA cleared devices: |
| | ● Arthrex iBalance TKA System |
| | ● Arthrex iBalance UKA System |
| | ● Arthrex iBalance PFJ |
| | ● Arthrex iBalance BiCompartmental Arthroplasty System |
| | These systems are comprised of femoral, tibia, and patellar components for use |
| | in knee prosthesis. |
| 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 |
| | ● Moderate varus, valgus, or flexion deformity in which the ligamentous |
| | structures can be returned to adequate function and stability; |
| | |

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- 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).

Arthrex iBalance UKA System is intended 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.

The Arthrex iBalance PFJ components are intended for use in patellofemoral knee arthroplasty in patients with:

- Degenerative arthritis in the distal femur and patella;
- A history of patellar dislocation or fracture;
- Failed previous surgery (arthroscopy, tibial tubercle elevation, lateral release) where pain, deformity or dysfunction persists.

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

When used concurrently, the Arthrex iBalance UKA and PFJ systems create the Arthrex iBalance BiCompartmental Arthroplasty System. The Arthrex iBalance BiCompartmental Arthroplasty System is intended to be used as a multicompartmental knee arthroplasty in patients with:

- Moderately disabling joint disease of the knee resulting from painful ● osteoarthritis or post traumatic arthritis;
- Correction of functional deformities;
- Revision of previous unsuccessful partial knee replacement or other procedure;

The BiCompartmental Arthroplasty System is not intended to be used as a dualcondyle or tri-compartmental knee.

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

Performance Data Non-clinical testing and in-vivo electromagnetic simulation per the FDA Guidance, "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment", demonstrated that the Arthrex Knee Systems are "MR Conditional".

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| | Bacterial endotoxin per EP 2.6.14/USP <85> was conducted to demonstrate that<br>the device meets pyrogen limit specifications. |
|------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Conclusion | The Arthrex Knee Systems are substantially equivalent to the predicate device in<br>which the basic design features and intended uses are the same. Any differences<br>between the proposed device and the predicate device are considered minor and<br>do not raise questions concerning safety or effectiveness. |
| | Based on the indications for use, technological characteristics, and the summary<br>of data submitted, Arthrex Inc. has determined that the proposed device is<br>substantially equivalent to the currently marketed predicate device. |
| | |