(90 days)
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.
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.
The provided text describes a 510(k) premarket notification for the "Balanced Knee Revision System Trabecular Tibial Cone Augments." This is a medical device (knee joint prosthesis component) and not an AI/ML-driven device or an imaging device.
Therefore, the requested information regarding acceptance criteria and study details for an AI/ML device (e.g., test set sample size, data provenance, expert ground truth, MRMC studies, standalone performance, training set details) is not applicable to this document.
The document discusses the substantial equivalence of the device to existing predicate devices based on technological characteristics and non-clinical performance testing.
Here's an assessment of the provided information relative to the device type described:
1. A table of acceptance criteria and the reported device performance:
The document lists the following non-clinical tests that were conducted and "successfully met the predetermined acceptance criteria." However, the specific numerical acceptance criteria and reported performance values are not detailed in this 510(k) summary. It only states that the tests met the criteria.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Successfully meet ASTM F2083 and ASTM F1800 for Tibial construct fatigue | Met predetermined acceptance criteria |
| Successfully meet Static compression standards | Met predetermined acceptance criteria |
| Successfully meet ASTM F1044, ASTM F1147, and ASTM F1160 for Mechanical testing | Met predetermined acceptance criteria |
| Successfully meet ASTM F1854 for Porous structure analysis | Met predetermined acceptance criteria |
| Successfully meet ASTM F136 and ASTM F3001 for Tensile properties and composition of material | Met predetermined acceptance criteria |
| Successfully meet ASTM F1978 for Abrasion resistance | Met predetermined acceptance criteria |
| Successfully meet ANSI/AAMI ST72 for Bacterial endotoxin testing using LAL pyrogen testing methodology | Met predetermined acceptance criteria |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This information is not applicable as this is a physical medical device, not an AI/ML imaging device. The "test set" here refers to physical specimens subjected to biomechanical and material tests, not a dataset for AI model evaluation. No data provenance in terms of country of origin or retrospective/prospective collection is relevant in this context.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
This is not applicable. Ground truth establishment by experts in the context of radiology or clinical interpretation is not relevant for this physical device's mechanical and material testing. The "ground truth" for these tests are the established ASTM and ANSI/AAMI standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This is not applicable. Adjudication methods are relevant for ambiguous or challenging cases in AI/ML performance evaluation, usually involving human experts. For mechanical testing, the results are objectively measured against predefined standards.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This is not applicable. MRMC studies are specific to imaging devices and AI/ML aids that influence human reader performance. This device is a prosthetic component.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable. Standalone performance refers to an algorithm's output without human intervention, which is not relevant for a physical implant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The ground truth for this device's performance evaluation lies in the established industry standards (ASTM, ANSI/AAMI) for mechanical, material, and biocompatibility testing. There is no "pathology" or "outcomes data" specifically mentioned for establishing ground truth for the premarket clearance of this component.
8. The sample size for the training set:
This is not applicable as this is not an AI/ML device.
9. How the ground truth for the training set was established:
This is not applicable as this is not an AI/ML device.
In summary: The provided document is a 510(k) summary for a physical orthopedic implant. The requested information pertains to an AI/ML or imaging device, which is a different category of medical product. Therefore, most of the specific questions are not applicable to the content of this document. The device's acceptance criteria are based on meeting established national and international standards for mechanical properties and biocompatibility.
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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
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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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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 Corporation12187 South Business Park DriveDraper, Utah 84020 |
|---|---|
| 510(k) Contact: | Adrienne von FollerSenior Regulatory Affairs SpecialistTelephone: (801) 619-8933Email: 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 patellofemorotibialpolymer/metal/polymer semi-constrained cemented prosthesis21 CFR 888.3565: Knee joint patellofemorotibial metal/polymerporous-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 ShellSystem; 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.
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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.
§ 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.