Arthrex iBalance Partial Knee System

K251453 · Arthrex, Inc. · HSX · Jul 1, 2025 · Orthopedic

Device Facts

• Record ID: K251453
• Device Name: Arthrex iBalance Partial Knee System
• Applicant: Arthrex, Inc.
• Product Code: HSX · Orthopedic
• Decision Date: Jul 1, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3520
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The iBalance UKA System is indicated 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 iBalance PFJ System is indicated for use in patellofemoral joint, (PFJ) knee arthroplasty as a result of: - 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 iBalance 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.

Device Story

Arthrex iBalance Partial Knee System consists of femoral, tibial, and patellar components for knee arthroplasty; used in unicompartmental, patellofemoral, or bicompartmental configurations. Implants are single-use, cemented, and surgically implanted by orthopedic surgeons in clinical settings. Submission updates labeling to 'MR Conditional' status per FDA guidance. Device provides structural replacement for damaged knee compartments; restores joint function; alleviates pain from arthritis or trauma. No changes to device design or materials; modification limited to MR safety labeling.

Clinical Evidence

No clinical data presented. Evidence consists of non-clinical bench testing and in-vivo electromagnetic simulation to support the MR Conditional labeling update.

Technological Characteristics

System comprises femoral, tibial, and patellar components for cemented knee arthroplasty. Design, materials, and form factor remain unchanged from predicate devices. Modification is strictly limited to updated MR Conditional labeling based on electromagnetic simulation testing.

Indications for Use

Indicated for patients with moderately disabling knee joint disease (osteoarthritis, post-traumatic arthritis), functional deformities, or failed prior surgeries requiring unicompartmental, patellofemoral, or bicompartmental knee arthroplasty. Includes patients requiring revision of unsuccessful partial knee replacements or those seeking alternatives to tibial osteotomy. Contraindicated for dual-condyle or tri-compartmental use.

Regulatory Classification

Identification

A knee joint femorotibial metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral condylar resurfacing component or components made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components made of ultra-high molecular weight polyethylene and are intended for use with bone cement (§ 888.3027).

Predicate Devices

• iBalance UKA Tibial Tray Implant (K200433)
• ACCIN Patellafemoral System (K073120)

Reference Devices

• Arthrex Knee Systems (K171365)
• Arthrex iBalance UKA System Vitamin E Tibial Bearing (K161060)
• Arthrex iBalance BiCompartmental Arthroplasty System (K160461)
• Arthrex iBalance Patella Implant, Dome (K143047)
• ACCIN UNI-Knee System (K063782)
• ACCIN UNI-Knee System (K060670)

Submission Summary (Full Text)

{0}

FDA U.S. FOOD & DRUG ADMINISTRATION

July 1, 2025

Arthrex Inc.
Tiffany Mentzel
Principal Regulatory Affairs Specialist
1370 Creeksidew Blvd.
Naples, Florida 34108

Re: K251453
Trade/Device Name: Arthrex iBalance Partial Knee System
Regulation Number: 21 CFR 888.3520
Regulation Name: Knee Joint Femorotibial Metal/Polymer Non-Constrained Cemented Prosthesis
Regulatory Class: Class II
Product Code: HSX, KRR
Dated: May 9, 2025
Received: May 12, 2025

Dear Tiffany Mentzel:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

{1}

K251453 - Tiffany Mentzel
Page 2

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-

{2}

K251453 - Tiffany Mentzel
Page 3

assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,


Lixin Liu, PhD
Assistant Director
DHT6A: Division of Joint Arthroplasty Devices
OHT6: Office of Orthopedic Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

{3}

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023
See PRA Statement below.

510(k) Number (if known)
K251453

Device Name
Arthrex iBalance® Partial Knee System

Indications for Use (Describe)
The iBalance UKA System is indicated 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 iBalance PFJ System is indicated for use in patellofemoral joint, (PFJ) knee arthroplasty as a result of:
- 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 iBalance 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)
☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

FORM FDA 3881 (6/20)
Page 1 of 2
PSC Publishing Services [phone]

{4}

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]

"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."

FORM FDA 3881 (6/20)
Page 2 of 2

{5}

Arthrex

K251453 Page 1 of 3

# 510(k) Summary

| Date Prepared | July 1, 2025 |
| --- | --- |
| Submitter | Arthrex Inc.
1370 Creekside Boulevard
Naples, FL 34108-1945 |
| Contact Person | Name: Tiffany Mentzel
Title: Principal Regulatory Affairs Specialist
Phone: [phone]
Email: [e-mail] |
| Trade Name | Arthrex iBalance® Partial Knee System |
| Common Name | Knee Prosthesis |
| Product Code | HSX, KRR |
| Classification Name | 21 CFR 888.3520 Knee joint femorotibial metal/polymer non-constrained cemented prosthesis
21 CFR 888.3540 Knee joint patellofemoral polymer/metal semi-constrained cemented prosthesis |
| Regulatory Class | II |
| Primary Predicate Device | K200433: iBalance UKA Tibial Tray Implant |
| Additional Predicate Devices | K073120: ACCIN Patellafemoral System |
| Reference Predicates | K171365: Arthrex Knee Systems
K161060: Arthrex iBalance UKA System Vitamin E Tibial Bearing
K160461: Arthrex iBalance BiCompartmental Arthroplasty System
K143047: Arthrex iBalance Patella Implant, Dome
K073120: ACCIN Patellafemoral System
K063782: ACCIN UNI-Knee System
K060670: ACCIN UNI-Knee System |
| Purpose of Submission | This Traditional 510(k) premarket notification is submitted to obtain clearance for the modification to the device labeling for the Arthrex iBalance Partial Knee System to include updates to 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 iBalance Partial Knee System encompass the following FDA cleared devices:
• Arthrex iBalance UKA System
• Arthrex iBalance PFJ System
• Arthrex iBalance BiCompartmental Arthroplasty System
These systems are comprised of femoral, tibia and patellar components for use in knee prosthesis. |
| Indications for Use | The iBalance UKA System is indicated for use in unicompartmental knee arthroplasty as a result of: |

Page 1 of 3

{6}

K251453 Page 2 of 3

# Arthrex

- 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 iBalance PFJ System is indicated for use in patellofemoral joint (PFJ) knee arthroplasty as a result of:
- 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 iBalance 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.

| Performance Data | Non-clinical testing and in-vivo electromagnetic simulation demonstrated that the Arthrex iBalance Partial Knee System is “MR Conditional”. |
| --- | --- |
| Technological Comparison | The proposed Arthrex iBalance Partial Knee System and predicate devices have the same basic design, materials, and |

Page 2 of 3

{7}

K251453 Page 3 of 3

# Arthrex

| | intended use. The only modification subject to this 510(k) is a labeling change which includes a new MR statement. |
| --- | --- |
| Conclusion | The Arthrex iBalance Partial Knee System is substantially equivalent to the predicate device in which the basic design features and intended uses are the same. Any differences between the proposed device and the predicate device do not raise different questions of safety or effectiveness.
Based on the indications for use, technological characteristics, and the summary of data submitted, Arthrex Inc. has determined that the proposed device is substantially equivalent to the currently marketed predicate device. |

Page 3 of 3