(134 days)
No
The summary describes a mechanical knee implant and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is a knee replacement system used in total knee arthroplasty procedures to address various knee joint conditions, which is a therapeutic intervention.
No
The device is a knee implant intended for total knee arthroplasty procedures, which is a treatment, not a diagnostic process.
No
The device description clearly outlines physical components made of Co-Cr-Mo and UHMWPE, indicating it is a hardware medical device (a knee prosthesis). There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "cemented total knee arthroplasty procedures" to treat various conditions affecting the knee joint. This is a surgical procedure involving the implantation of a medical device.
- Device Description: The device is described as a "semi-constrained modular knee prosthesis" consisting of femoral and tibial components made of materials like Co-Cr-Mo and UHMWPE. This is a physical implant.
- Lack of IVD Characteristics: IVD devices are used in vitro (outside the body) to examine specimens (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening. The description of the Balanced Knee System High Flex PS does not involve any such in vitro testing or analysis of biological samples.
The Balanced Knee System High Flex PS is clearly a medical device intended for surgical implantation to replace a damaged knee joint.
N/A
Intended Use / Indications for Use
The Balanced Knee System High Flex PS is intended for use in cemented total knee arthroplasty procedures with the following indications:
-
- Loss of knee joint configuration and joint function.
-
- Osteoarthritis of the knee joint.
- ന് 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 Balanced Knee System High Flex PS (High Flex PS) is designed to accommodate increased range of motion up to 150° of flexion. The High Flex PS includes a highly polished Co-Cr-Mo PS femoral component and a compression molded UHMWPE PS tibial insert component. The High Flex PS femoral and insert components may be used in conjunction with the Balanced Knee System (BKS) standard and modular tibial trays, tibial augments, stems, and patellae to complete the semi-constrained modular knee prosthesis.
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
Not Found
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.
0
K12345
MAR 2 2 2013
510(k) Summary
| NAME OF SPONSOR: | Ortho Development Corporation
12187 South Business Park Drive
Draper, Utah 84020 |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) CONTACT: | Tom Haueter
Regulatory Affairs Manager
Telephone: (801) 553-9991
Facsimile: (801) 553-9993
Email: thaueter@orthodevelopment.com |
| DATE PREPARED: | October 29, 2012 |
| PROPRIETARY NAME: | Balanced Knee System High Flex PS |
| COMMON NAME: | Total Knee Replacement Prosthesis |
| CLASSIFICATION: | 21 CFR 888.3560, Knee joint, patellofemorotibial,
polymer/metal/polymer semi-constrained cemented prosthesis,
Class II device |
| DEVICE PRODUCT CODE: | JWH |
| PREDICATE DEVICES: | Balanced Knee System (K994370), Ortho Development Corp. |
| | LPS-Flex Fixed Bearing Femoral and Articular Surface Components
(K991581), Zimmer |
Device Description
The Balanced Knee System High Flex PS (High Flex PS) is designed to accommodate increased range of motion up to 150° of flexion. The High Flex PS includes a highly polished Co-Cr-Mo PS femoral component and a compression molded UHMWPE PS tibial insert component. The High Flex PS femoral and insert components may be used in conjunction with the Balanced Knee System (BKS) standard and modular tibial trays, tibial augments, stems, and patellae to complete the semi-constrained modular knee prosthesis.
1
Intended Use
The Balanced Knee System High Flex PS is intended for use in cemented total knee arthroplasty procedures with the following indications:
-
- Loss of knee joint configuration and joint function.
-
- Osteoarthritis of the knee joint.
- ന് 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.
Performance Data
| Property | Result |
|---|---|
| Range of Motion | Up to 150° flexion; Similar to predicate device, LPS-Flex |
| Femoral Fatigue | Improved Fatigue Strength over predicate device, BKS; |
| Sufficient strength to survive in-vivo loading | |
| Femorotibial | |
| Constraint | Similar to predicate device, BKS |
| Femorotibial | |
| Contact Area | Similar to predicate device, BKS |
| Patellofemoral | |
| Constraint | Similar to predicate device, BKS |
| Patellofemoral | |
| Contact Area | Similar to predicate device, BKS |
| PS Spine Fatigue | Sufficient strength to survive in-vivo loading |
Basis for Substantial Equivalence
Ortho Development believes that the Balanced Knee System High Flex PS is substantially equivalent to the previously cleared predicate devices based on similarities in intended use, design, materials, manufacturing methods, packaging, and mechanical performance.
Section 5, 510(k) Summary
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 22, 2013
Ortho Development Corporation % Mr. Tom Haueter Regulatory Affairs Manager 12187 South Business Park Drive Draper, Utah 84020
Re: K123457
Trade/Device Name: Balanced Knee® System High Flex PS Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: JWH Dated: February 8, 2013 Received: February 21, 2013
Dear Mr. Haueter:
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 enactnent date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the Medical Device Amendments, or to
and Cosmetic Act (Act (Act (Act (Act (Act (Act ) the provisions of the Federal Foo and Cosmetic Act (Act) that do not require approval of the Federal Food, Drug,
You may, therefore, market the devices cubicat of the sproval application (PMA). You may, therefore, market the device, subject to the general controls provisions (Phe
The general controls provisions of the Artical i 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 regulations administered by other registration and listing (21
3
Page 2 - Mr. Tom Haueter
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (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); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Erin.D.Keith
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indication for Use Form Ortho Development Balanced Knee® System High Flex PS 510(k)
510(k) Number (if known): K123457
Device Name: Balanced Knee® System High Flex PS
Indications for Use:
The Balanced Knee® System High Flex PS is intended for use in cemented total knee arthroplasty procedures.
Total knee arthroplasty is indicated for the following conditions:
-
- Loss of knee 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.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ × (Part 21 CFR 801 Subpart D)
AND/OR '
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Casey E. Hanley, Ph.D.
Division of Orthopaedic Devices