Balanced Knee Revision System - Offset Junction Box

K180743 · Ortho Development Corporation · JWH · Jun 20, 2018 · Orthopedic

Device Facts

• Record ID: K180743
• Device Name: Balanced Knee Revision System - Offset Junction Box
• Applicant: Ortho Development Corporation
• Product Code: JWH · Orthopedic
• Decision Date: Jun 20, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

This device is intended for use in total knee arthroplasty procedures for the following conditions: 1. Loss of joint configuration and joint function. 2. Osteoarthritis of the knee joint. 3. Rheumatoid arthritis of the knee joint. 4. Post-traumatic arthritis of the knee joint. 5. Valgus, varus, or flexion deformities of the knee joint. 6. Revision procedures where other treatments or devices have failed.

Device Story

Balanced Knee Revision System - Offset Junction Box is a single-use modular orthopedic implant component. It serves as an attachment interface between a modular femoral component and a stem extension in revision knee arthroplasty. Available in 0mm and 5mm offset configurations with 5° or 7° valgus angles. Used by orthopedic surgeons in clinical settings during revision knee surgery. The device provides structural connectivity to restore joint configuration and function. Benefits include enabling surgical revision when previous knee arthroplasty treatments have failed.

Clinical Evidence

No clinical data. Evidence consists of bench testing only, including static torsion, static axial and shear, and cyclic fatigue testing per ASTM F-1814, alongside LAL pyrogen testing for bacterial endotoxins.

Technological Characteristics

Modular orthopedic implant component; single-use; available in 0mm/5mm offsets and 5°/7° valgus angles. Mechanical testing performed per ASTM F-1814. Sterilization and packaging methods are consistent with the predicate device.

Indications for Use

Indicated for patients undergoing total knee arthroplasty due to loss of joint function, osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, or valgus/varus/flexion deformities, including revision procedures where prior treatments failed.

Regulatory Classification

Identification

A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).

Predicate Devices

• Balanced Knee Revision System, Stem Junction Box (K060569)

Submission Summary (Full Text)

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

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Ortho Development Corporation Dan Petersen Regulatory Affairs Specialist 12187 So. Business Park Drive Draper, Utah 84020

June 20, 2018

Re: K180743

Trade/Device Name: Balanced Knee Revision System - Offset Junction Box Regulation Number: 21 CFR 888.3560 Regulation Name: Knee Joint Patellofemorotibial Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: JWH Dated: March 20, 2018 Received: March 22, 2018

Dear Dan Petersen:

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);

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

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 comprehensive regulatory information about medical devices and radiation-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

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

## Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

#### 510(k) Number (if known)

K180743

Device Name

Balanced Knee® Revision System - Offset Junction Box

Indications for Use (Describe)

This device is intended for use in total knee arthroplasty procedures for the following conditions:

- 1. Loss of joint configuration and joint function.
- 2. Osteoarthritis of the knee joint.
- 3. Rheumatoid arthritis of the knee joint.
- 4. Post-traumatic arthritis of the knee joint.
- 5. Valgus, varus, or flexion deformities of the knee joint.
- 6. Revision procedures where other treatments or devices have failed.

| Type of Use (Select one or both, as applicable) | | |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|
| <table style="border:none"><tr><td><span style="font-size:12px">☑ Residential Use (Part 1 of SEC 201 Subject Site)</span></td><td><span style="font-size:12px">☐ On-Site Construction (21-277 SEC Subject Site)</span></td></tr></table> | <span style="font-size:12px">☑ Residential Use (Part 1 of SEC 201 Subject Site)</span> | <span style="font-size:12px">☐ On-Site Construction (21-277 SEC Subject Site)</span> |
| <span style="font-size:12px">☑ Residential Use (Part 1 of SEC 201 Subject Site)</span> | <span style="font-size:12px">☐ On-Site Construction (21-277 SEC Subject Site)</span> | |

X 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

"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}------------------------------------------------

12187 So. Business Park Drive Draper, Utah 84020 801-553-9991/ fax [phone] Orthodevelopment.com

Image /page/3/Picture/2 description: The image shows the logo for Ortho Development. The logo consists of a purple circle with three gray arcs emanating from the left side, followed by the word "ORTHO" in purple, block letters. Below the word "ORTHO" is the word "DEVELOPMENT" in gray, smaller font.

## 510(k) Summary

| Name of Sponsor: | Ortho Development Corporation<br>12187 South Business Park Drive<br>Draper, Utah 84020 |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Contact: | Dan Petersen<br>Regulatory Affairs Specialist<br>Telephone: [phone]<br>Facsimile: [phone]<br>Email: [e-mail] |
| Date Prepared: | March 20, 2018 |
| Submission Type: | Traditional 510(k) |
| Proprietary Name: | Balanced Knee® Revision System - Offset Junction Box |
| Common Name: | Offset Junction Box |
| Classification: | 21 CFR 888.3560: Knee joint patellofemorotibial<br>polymer/metal/polymer semi-constrained cemented prosthesis. |
| Device Class: | Class II device |
| Device Product Code: | JWH |
| Predicate Devices: | K060569 – Balanced Knee Revision System, Stem Junction Box;<br>Ortho Development Corporation |

## 5.1 Device Description

The Offset Junction Box is part of the Balanced Knee® Revision System and is a single use modular device used in revision knee surgery to provide an attachment point between a modular femoral component and a stem extension.

The Offset Junction Box is available in four size options: 0mm and 5mm offset configurations with either a 5° or 7° valgus angle.

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

## 5.2 Indications for Use

This device is intended for use in total knee arthroplasty procedures for the following conditions:

- 1. Loss of joint configuration and joint function.
- 2. Osteoarthritis of the knee joint.
- Rheumatoid arthritis of the knee joint. 3.
- 4. Post-traumatic arthritis of the knee joint.
- 5. Valgus, varus, or flexion deformities of the knee joint.
- 6. Revision procedures where other treatments or devices have failed.

## 5.3 Basis for Substantial Equivalence:

The Offset Junction Box has the same technological characteristics as the predicate device. These include:

- 1. Indications for use
- 2. Intended use
- 3. Basic design
- 4. Function
- 5. Manufacturer
- 6. Manufacturing Process
- 7. Sterilization
- 8. Packaging

The following non-clinical mechanical tests were conducted on the worst-case configurations of the Offset Junction Box:

- 1. Static torsion per ASTM F-1814
- 2. Static axial and shear per ASTM F-1814
- 3. Cyclic fatigue per ASTM F-1814

Bacterial endotoxin testing was also performed using LAL pyrogen testing methodology and met the predetermined acceptance criteria.

The fundamental scientific technology of the Offset Junction Box is the same as the previously cleared device. The mechanical test results demonstrate that the Offset Junction Box is safe and effective.

Based on similarities in intended use, design, manufacturing methods, sterilization, packaging, and the mechanical test results, the Offset Junction Box is substantially equivalent to the predicate device that was cleared under K060569.