(90 days)
Not Found
No
The device description and performance studies focus on mechanical properties and traditional medical device testing, with no mention of AI or ML.
No
The device is described as a "modular device used in revision knee surgery to provide an attachment point between a modular femoral component and a stem extension." It is a component of a knee implant system, not a device used for treating a condition directly; rather, it is a structural part of a surgical implant.
No
The device description and intended use indicate that the Offset Junction Box is a modular component used in knee surgery to provide an attachment point between other components. It is not described as assessing, detecting, monitoring, or diagnosing any medical condition. Its function is mechanical within a surgical procedure.
No
The device description clearly states it is a "single use modular device" and describes physical components ("attachment point between a modular femoral component and a stem extension," "available in four size options: 0mm and 5mm offset configurations with either a 5° or 7° valgus angle"). The performance studies are mechanical tests on physical components. This indicates a hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used during a surgical procedure (total knee arthroplasty) to address specific conditions of the knee joint. This is a therapeutic and surgical intervention, not a diagnostic test performed on biological samples in vitro.
- Device Description: The device is a physical component (Offset Junction Box) used to connect other components of a knee implant system. It is a mechanical device used within the body during surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) or to provide diagnostic information about a patient's condition based on such analysis. The performance studies focus on mechanical properties and bacterial endotoxin, which are relevant to an implantable surgical device, not an IVD.
In summary, the device is a surgical implant component used in knee replacement surgery, which falls under the category of medical devices used for treatment and repair, not for in vitro diagnosis.
N/A
Intended Use / Indications for Use
This device is intended for use in total knee arthroplasty procedures for the following conditions:
- Loss of joint configuration and joint function.
- Osteoarthritis of the knee joint.
- Rheumatoid arthritis of the knee joint.
- Post-traumatic arthritis of the knee joint.
- Valgus, varus, or flexion deformities of the knee joint.
- Revision procedures where other treatments or devices have failed.
Product codes
JWH
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee joint
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
The following non-clinical mechanical tests were conducted on the worst-case configurations of the Offset Junction Box:
- Static torsion per ASTM F-1814
- Static axial and shear per ASTM F-1814
- Cyclic fatigue per ASTM F-1814
Bacterial endotoxin testing was also performed using LAL pyrogen testing methodology and met the predetermined acceptance criteria.
The mechanical test results demonstrate that the Offset Junction Box is safe and effective.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
(a)
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).(b)
Classification. Class II.
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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)
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:
-
- Loss of joint configuration and joint function.
-
- Osteoarthritis of the knee joint.
-
- Rheumatoid arthritis of the knee joint.
-
- Post-traumatic arthritis of the knee joint.
-
- Valgus, varus, or flexion deformities of the knee joint.
-
- Revision procedures where other treatments or devices have failed.
| Type of Use (Select one or both, as applicable) | ||
|---|---|---|
| ☑ Residential Use (Part 1 of SEC 201 Subject Site)☐ On-Site Construction (21-277 SEC Subject Site) | ☑ Residential Use (Part 1 of SEC 201 Subject Site) | ☐ On-Site Construction (21-277 SEC Subject Site) |
| ☑ Residential Use (Part 1 of SEC 201 Subject Site) | ☐ On-Site Construction (21-277 SEC Subject Site) |
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.
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3
12187 So. Business Park Drive Draper, Utah 84020 801-553-9991/ fax 553-9993 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
12187 South Business Park Drive
Draper, Utah 84020 |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Contact: | Dan Petersen
Regulatory Affairs Specialist
Telephone: (801) 619-3416
Facsimile: (801) 619-8916
Email: RA@OrthoDevelopment.com |
| 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
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;
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:
-
- Loss of joint configuration and joint function.
-
- Osteoarthritis of the knee joint.
- Rheumatoid arthritis of the knee joint. 3.
-
- Post-traumatic arthritis of the knee joint.
-
- Valgus, varus, or flexion deformities of the knee joint.
-
- 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:
-
- Indications for use
-
- Intended use
-
- Basic design
-
- Function
-
- Manufacturer
-
- Manufacturing Process
-
- Sterilization
-
- Packaging
The following non-clinical mechanical tests were conducted on the worst-case configurations of the Offset Junction Box:
-
- Static torsion per ASTM F-1814
-
- Static axial and shear per ASTM F-1814
-
- 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.