(219 days)
Not Found
No
The document describes a standard knee replacement system made of traditional materials (Cobalt Chromium, Titanium, Polyethylene) and does not mention any software, algorithms, or capabilities related to AI or ML. The performance studies focus on sterilization, shelf life, biocompatibility, and mechanical testing, which are typical for orthopedic implants.
Yes
The device is a knee replacement system used to treat joint diseases and deformities, which are conditions that impair normal bodily function. This aligns with the definition of a therapeutic device designed to alleviate or cure a medical condition.
No
The device is a knee replacement system intended for unicompartmental knee arthroplasty procedures, which is a therapeutic device, not a diagnostic one.
No
The device description clearly outlines physical components made of cobalt chromium, titanium, and polyethylene, indicating it is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description and Intended Use: The description clearly states that this device is a single compartment knee replacement intended for implantation in the knee joint during unicompartmental knee arthroplasty procedures. It is a physical implant designed to replace damaged joint components.
- Lack of Diagnostic Function: There is no mention of this device being used to analyze samples, perform tests, or provide diagnostic information about a patient's condition based on biological samples.
Therefore, this device falls under the category of a surgical implant or prosthetic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
- Non-inflammatory degenerative joint diseases (NIDJD), e.g., osteoarthritis, avascular necrosis
- Traumatic arthritis
- Previous tibial condyle or plateau fracture with loss of anatomy or function
- Varus deformities
- Revision of the tibial bearing insert of a previously implanted unicompartmental knee system provided that the tibial tray mechanism is not compromised, and femoral and tibial tray components remain well fixed and undamaged.
The BKS Uni is intended for unicompartmental knee arthroplasty procedures. The system is single-use and intended for implantation with bone cement.
Product codes
HSX
Device Description
The Balanced Knee® System (BKS®) Uni is a single compartment knee replacement. The BKS Uni is indicated for cemented use only.
Cobalt Chromium Femoral Component
The femoral components are cobalt chromium (Co-Cr-Mo). The femoral components are right and left specific and are intended for cemented use only.
Titanium Tibial Trays
The titanium tibial trays (Ti-6Al-4V ELI) are left and right specific and are for cemented use only.
Polyethylene Tibial Insert
The E-Vitalize tibial insert is manufactured from crosslinked Vitamin E Ultra High Molecular Weight Polyethylene. The inserts match the respective size of the tibial tray used.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Sterilization (ISO 11137-1:2006, Am1:2013, ISO 11137-2:2013, ISO 11135:2014/Amd.1:2018(E))
Shelf Life (ISO 11607-1:2006, ISO 11607-2:2006)
Biocompatibility (ISO 10993-1:2009)
Mechanical Testing (Range of Motion Test, Constraint Test, Component Interlock Strength Test, Tibial Component Fatigue Test, Contact Area/Stress Test, Femoral Fatigue Test, Wear Test Analysis)
Clinical Testing: No clinical testing of the Balanced Knee® System Uni has been conducted.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3520 Knee joint femorotibial metal/polymer non-constrained cemented prosthesis.
(a)
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).(b)
Classification. Class II.
0
December 16, 2021
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Ortho Development Corporation Drew Weaver Director of Regulatory & Clinical Affairs 12187 South Business Park Drive Draper. Utah 84020
Re: K211471
Trade/Device Name: Balanced Knee® System Uni Regulation Number: 21 CFR 888.3520 Regulation Name: Knee Joint Femorotibial Metal/Polymer Non-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: HSX Dated: November 10, 2021 Received: November 12, 2021
Dear Drew Weaver:
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 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
1
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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-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 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Ting Song, Ph.D., R.A.C. 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
2
Indications for Use
510(k) Number (if known)
K211471
Device Name Balanced Knee® System Uni
Indications for Use (Describe)
-
Non-inflammatory degenerative joint diseases (NIDJD), e.g., osteoarthritis, avascular necrosis
-
Traumatic arthritis
-
Previous tibial condyle or plateau fracture with loss of anatomy or function
-
Varus deformities
-
Revision of the tibial bearing insert of a previously implanted unicompartmental knee system provided that the tibial tray mechanism is not compromised, and femoral and tibial tray components remain well fixed and undamaged.
The BKS Uni is intended for unicompartmental knee arthroplasty procedures. The system is single-use and intended for implantation with bone cement.
Type of Use (Select one or both, as applicable)
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
K211471 page 1 of 4
Section 5
510(k) Summary
In accordance with Title 21 of the Code of Federal Regulations, Part 807, and in particular 21 CFR §807.92, the following summary of information is provided:
| Name of the Sponsor: | Ortho Development® Corporation
12187 South Business Park Drive
Draper, Utah 84020 |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Primary Contact: | Name: Divya Palan
Position: Regulatory Affairs Specialist
Telephone: (617) 459-9652
Email: DPalan@orthodevelopment.com |
| 510(k) Secondary Contact: | Name: Darlene Hull
Position: Director of Regulatory and Clinical Affairs.
Telephone: (801) 619-3499
Email: DHull@orthodevelopment.com |
| Date Prepared: | May 10, 2021 |
| Submission Type: | Traditional 510(k) |
| Proprietary Name: | Balanced Knee® System Uni |
| Common Name: | Knee joint femorotibial metal/polymer non-constrained
cemented prosthesis |
| Classification: | 21 CFR 888.3520 |
| Device Class: | Class II |
| Device Product Code: | HSX |
| Primary Predicate Device: | Zimmer Unicompartmental Knee System (K033363) |
| Secondary Predicate Device: | EMPOWR Partial Knee System (K191325) |
4
K211471 page 2 of 4
5.1 Device Description:
The Balanced Knee® System (BKS®) Uni is a single compartment knee replacement. The BKS Uni is indicated for cemented use only.
Cobalt Chromium Femoral Component
The femoral components are cobalt chromium (Co-Cr-Mo). The femoral components are right and left specific and are intended for cemented use only.
Titanium Tibial Trays The titanium tibial trays (Ti-6Al-4V ELI) are left and right specific and are for cemented use only.
Polyethylene Tibial Insert The E-Vitalize tibial insert is manufactured from crosslinked Vitamin E Ultra High Molecular Weight Polyethylene. The inserts match the respective size of the tibial tray used.
5.2 Indication for Use:
-
- Non-inflammatory degenerative joint diseases (NIDJD), e.g., osteoarthritis, avascular necrosis
-
- Traumatic arthritis
-
- Previous tibial condyle or plateau fracture with loss of anatomy or function
-
- Varus deformities
-
- Revision of the tibial bearing insert of a previously implanted unicompartmental knee system provided that the tibial tray mechanism is not compromised, and femoral and tibial tray components remain well fixed and undamaged.
The BKS Uni is intended for unicompartmental knee arthroplasty procedures. The system is single-use and intended for implantation with bone cement.
5.3 Comparison of Technological Characteristic:
The Balanced Knee® System Uni is technologically similar to the already cleared predicate device Zimmer Unicompartmental Knee System (K033363) and EMPOWR Partial Knee System (K191325) in terms of indication for use/intended use, technological characteristics, basic design, device material, and principle of operation.
5
K211471 page 3 of 4
5.4 Performance Data:
Sterilization
The Balanced Knee® System Uni is gamma radiation and ethylene oxide sterilized and was validated to a sterility assurance level of 10° in accordance with the following standards:
- ISO 11137-1:2006, Am1:2013, Sterilization of health care products Requirements . for validation and routine control - Radiation sterilization; and
- . ISO 11137-2:2013, Sterilization of health care products – Radiation – Part 2: Establishing the sterilization dose.
- ISO 11135:2014/Amd.1:2018(E), Sterilization of health-care products -. Requirements for the development, validation and routine control of sterilization process for medical devices.
Validation results indicate that the Balanced Knee® System Uni complies with the standards.
Shelf Life
The packaging of Balanced Knee® System Uni was validated in accordance with the following standards:
- ISO 11607-1:2006 Packaging for terminally sterilized medical devices Part 1: . requirements for materials, sterile barrier systems and packaging systems; and
- ISO 11607-2:2006 Packaging for terminally sterilized medical devices Part 2: . Validation requirements for forming, sealing and assembly processes.
Validation results indicate that the packaging for the Balanced Knee® System Uni complies with the standards.
Biocompatibility
The Balanced Knee® System Uni contact materials were verified in accordance with the following standards:
- ISO 10993-1:2009, Biological evaluation of medical device Part 1: Evaluation and . testing within a risk management process.
6
K211471 page 4 of 4
Validation results indicate that the biological evaluation complies with the standard.
Mechanical Testing
The following non-clinical mechanical tests and analyses were conducted on the subject device.
- Range of Motion Test .
- Constraint Test .
- Component Interlock Strength Test .
- Tibial Component Fatigue Test .
- . Contact Area/Stress Test
- Femoral Fatigue Test ●
- Wear Test Analysis .
Clinical Testing
No clinical testing of the Balanced Knee® System Uni has been conducted.
5.5 Substantial Equivalence Conclusion:
Verification and Validation activities were conducted to establish the performance of Balanced Knee® System Uni. The results of these activities demonstrate that Balanced Knee® System Uni is as safe, as effective, and performs as well as the legally marketed predicates.
Based on similarities in indication for use/intended use, technological characteristic, basic design, device material, and principle of operation, Balanced Knee® System Uni is considered substantially equivalent to the previously cleared predicate devices.