(90 days)
No
The 510(k) summary describes a mechanical implant (tibial cone augments) and its intended use and performance testing. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The performance studies are based on mechanical testing of the device itself.
Yes
The device is described as an implant used in total knee arthroplasty procedures to address various knee conditions and provides additional support to the tibial implant, directly treating a medical condition.
No
The device is described as an implant used in total knee arthroplasty procedures to provide support and reinforcement, not to diagnose a condition.
No
The device description clearly states it is a system of "single-use modular cone augment implants" which are physical components used in surgery, not software. The performance studies also focus on mechanical and material properties of these implants.
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 surgical implant for total knee arthroplasty procedures to address various knee conditions. This is a therapeutic intervention, not a diagnostic test performed on samples from the body.
- Device Description: The device is described as a modular cone augment implant used in revision knee surgery to provide support and reinforcement to the tibia. This is a physical implant, not a reagent, instrument, or system used to examine specimens.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific markers, or providing diagnostic information about a patient's health status.
The device is a surgical implant used in vivo (within the body) during a surgical procedure, which is fundamentally different from an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
These devices are 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.
The BKS Revision is indicated in the salvage of previously failed surgical attempts where bone loss may require the use of augments, sleeves, cones or stem extensions.
The BKS Revision System Trabecular Tibial Cone Augments are for cemented or cementless use.
Product codes
JWH, MBH
Device Description
The Balanced Knee® Revision System (BKS® Revision) Trabecular Tibial Cone Augments are an addition to the Balanced Knee® Revision System to provide optional single-use modular cone augment implants used in revision knee surgery. The subject device provides additional support to the tibial implant and reinforcement to the proximal tibia when bone voids are present. The subject device is designed for cemented or uncemented fixation with the bone.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee joint (proximal tibia)
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
Non-clinical tests were conducted and successfully met the predetermined acceptance criteria:
-
- Tibial construct fatigue per ASTM F2083 and ASTM F1800
-
- Static compression
-
- Mechanical testing per ASTM F1044, ASTM F1147, and ASTM F1160
-
- Porous structure analysis per ASTM F1854
-
- Tensile properties and composition of material per ASTM F136 and ASTM F3001
-
- Abrasion resistance per ASTM F1978
-
- Bacterial endotoxin testing using LAL pyrogen testing methodology per ANSI/AAMI ST72
Key results: The test results further demonstrate that the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate. No clinical studies were deemed necessary for a determination of substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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.
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 Adrienne Von Foller Sr. Regulatory Affairs Specialist 12187 So. Business Park Drive Draper, Utah 84020
October 31, 2018
Re: K182085
Trade/Device Name: Balanced Knee Revision System Trabecular Tibial Cone Augments Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH, MBH Dated: August 1, 2018 Received: August 2, 2018
Dear Adrienne Von Foller:
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. 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 located 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.
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
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 4, Subpart A) for combination products; 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 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely, Daniel S. Ramsey -S 2018.10.31 14:59:18 -04'00'
For 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)
Device Name
Balanced Knee® Revision System Trabecular Tibial Cone Augments
Indications for Use (Describe)
These devices are 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.
The BKS Revision is indicated in the salvage of previously failed surgical attempts where bone loss may require
the use of augments, sleeves, cones or stem extensions.
The BKS Revision System Trabecular Tibial Cone Augments are for cemented or cementless use.
| 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) | ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ||
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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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 is purple and features a stylized "O" shape with gray arcs above it. The text "ORTHO" is written in capital letters to the right of the "O" shape, and the word "DEVELOPMENT" is written in smaller letters below the "ORTHO" text.
510(k) Summary
| Name of Sponsor: | Ortho Development Corporation
12187 South Business Park Drive
Draper, Utah 84020 |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Contact: | Adrienne von Foller
Senior Regulatory Affairs Specialist
Telephone: (801) 619-8933
Email: RA@OrthoDevelopment.com |
| Date Prepared: | July 30, 2018 |
| Submission Type: | Traditional 510(k) |
| Proprietary Name: | Balanced Knee® Revision System Trabecular Tibial Cone Augments |
| Common Name: | Knee Joint Replacement Prosthesis |
| Classification: | 21 CFR 888.3560: Knee joint patellofemorotibial
polymer/metal/polymer semi-constrained cemented prosthesis
21 CFR 888.3565: Knee joint patellofemorotibial metal/polymer
porous-coated uncemented prosthesis |
| Device Class: | Class II |
| Device Product Code: | JWH, MBH |
| Predicate Device: | K053340, K102896 - Trabecular Metal Tibial Cone Augments;
Zimmer®, Inc. |
| Reference Device: | K132312 – Tesera Trabecular Technology (T³) Acetabular Shell
System; Renovis® Surgical Technologies, Inc. |
5.1 Device Description
The Balanced Knee® Revision System (BKS® Revision) Trabecular Tibial Cone Augments are an addition to the Balanced Knee® Revision System to provide optional single-use modular cone augment implants used in revision knee surgery. The subject device provides additional support to the tibial implant and reinforcement to the proximal tibia when bone voids are present. The subject device is designed for cemented or uncemented fixation with the bone.
4
5.2 Indications for Use
The subject 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.
The BKS Revision is indicated in the salvage of previously failed surgical attempts where bone loss may require the use of augments, sleeves, cones or stem extensions.
The BKS Revision System Trabecular Tibial Cone Augments are for cementless use.
5.3 Basis for Substantial Equivalence:
The BKS® Revision Trabecular Tibial Cone Augments have technological characteristics as the predicate device. These include:
-
- Indications for use
-
- Intended use
-
- Basic principles of operation
-
- Basic design
-
- Sterilization
The following non-clinical tests were conducted and successfully met the predetermined acceptance criteria:
-
- Tibial construct fatigue per ASTM F2083 and ASTM F1800
-
- Static compression
-
- Mechanical testing per ASTM F1044, ASTM F1147, and ASTM F1160
-
- Porous structure analysis per ASTM F1854
-
- Tensile properties and composition of material per ASTM F136 and ASTM F3001
-
- Abrasion resistance per ASTM F1978
-
- Bacterial endotoxin testing using LAL pyrogen testing methodology per ANSI/AAMI ST72 Note: Where testing was performed according to a recognized consensus standard, the designation
number of the standard is referenced above.
The fundamental scientific technology of the BKS® Revision Trabecular Tibial Cone Augments is the same as the previously cleared predicate. The test results further demonstrate that the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate. No clinical studies were deemed necessary for a determination of substantial equivalence.
The intended use of the subject device is the same as the predicate. Based on similarities in indications for use, basic design, and the principle of operation, the BKS® Revision Trabecular Tibial Cone Augments are substantially equivalent to the previously cleared predicate device.