(88 days)
No
The summary describes a traditional mechanical knee replacement system with no mention of AI or ML in its function, design, or intended use.
Yes
The device is a knee replacement system used to treat severe knee pain and disability caused by degenerative bone diseases and traumatic arthritis, which falls under the definition of a therapeutic device.
No
Explanation: The device is described as a "total knee replacement system" intended to replace diseased and arthritic knees, indicating it is a prosthetic device for treatment rather than diagnosis.
No
The device description clearly states it consists of femoral, tibial, and patellar components made from CoCr alloy, Ti-6Al-4V alloy, and UHMWPE, which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a total knee replacement system for patients suffering from severe knee pain and disability due to various degenerative and traumatic conditions. This is a surgical implant, not a diagnostic test performed on samples from the body.
- Device Description: The description details the components (femoral, tibial, patellar) and materials (CoCr alloy, Ti-6Al-4V alloy, UHMWPE) of a prosthetic knee joint. This aligns with a surgical implant, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's condition based on in vitro testing.
In summary, the Ortho Development Balanced Knee™ System is a medical device (specifically, a surgical implant) used for treatment, not an in vitro diagnostic device used for diagnosis.
N/A
Intended Use / Indications for Use
The Ortho Development Balanced Knee™ System is indicated for patients suffering from severe knee pain and disability. Specific indications include femoral, tibial and patellar replacement due to degenerative bone disease such as rheumatoid arthritis or osteoarthritis. primary and secondary traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral condyles, pseudo-gout, or complications from a previous prosthesis. This device is intended for cemented use only.
The Balanced Knee™ System is intended for single use in primary total knee replacement only. Indications include:
- 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;
- Moderate valgus, varus, or flexion deformities.
Product codes
JWH
Device Description
The Ortho Development Balanced Knee™ System is a semi-constrained total knee replacement system, consisting of femoral, tibial and patellar components.
Materials: The devices are manufactured from CoCr alloy (cast or Wrought), Ti-6Al-4V alloy and Ultra High Molecular Weight Polyethylene (UHMWPE) per ASTM standards.
Function: The system functions to provide restoration of function as a replacement for diseased and arthritic knees.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K994370, Performance Total Knee System (Kirschner), NexGen Total Knee System (Zimmer), PCA Modular Total Knee System (Howmedica), Natural Knee System (Intermedics), AGC Modular Total Knee System (Biomet), Foundation Total Knee System (Encore)
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
MAR 2 4 2 100
SUMMARY OF SAFETY AND EFFECTIVENESS:
This safety and effectiveness summary for the Ortho Development Balanced Knee™ System is provided as required per Section 513(i)(3) of the Food, Drug, and Cosmetic Act.
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- Submitter: Ortho Development Corporation 106 West 12200 South Draper, Utah 84020
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- Contact Person: Carol Freasier Telephone: (801) 553-9991 Fax: (801) 553-9993
- Ortho Development Balanced Knee™ System 3. Trade Name: Balanced Knee™ System Common Name: Classification Name: Prosthesis, Knee patellofemorotibial, Semi-constrained, Cemented, Polymer/Metal/Polymer (888.3560)
4. Predicate or legally marketed devices which are substantially equivalent:
- Performance Total Knee System (Kirschner) ●
- NexGen Total Knee System (Zimmer) .
- PCA Modular Total Knee System (Howmedica) ●
- Natural Knee System (Intermedics) .
- AGC Modular Total Knee System (Biomet) .
- Foundation Total Knee System (Encore) .
5. Description of the device:
The Ortho Development Balanced Knee™ System is a semi-constrained total knee replacement system, consisting of femoral, tibial and patellar components.
- The devices are manufactured from CoCr alloy (cast or Wrought), Ti-6Al-4V alloy Materials: and Ultra High Molecular Weight Polyethylene (UHMWPE) per ASTM standards,
- The system functions to provide restoration of function as a replacement for Function: diseased and arthritic knees.
6. Intended Use:
The Ortho Development Balanced Knee™ System is indicated for patients suffering from severe knee pain and disability. Specific indications include femoral, tibial and patellar replacement due to degenerative bone disease such as rheumatoid arthritis or osteoarthritis. primary and secondary traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral condyles, pseudo-gout, or complications from a previous prosthesis. This device is intended for cemented use only.
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- Comparison of the technological characteristics of the device to predicate and legally marketed devices:
There are no significant differences between the Ortho Development Balanced Knee™ System and the systems currently being marketed which would adversely affect the use of the product. It is substantially equivalent to these other devices in design, function, material and intended use.
- Comparison of the technological characteristics of the device to predicate and legally marketed devices:
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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is facing left and has three lines representing its wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 4 2000
Ms. Carol Freasier Regulatory Affairs / Quality Assurance Ortho Development Corporation 106 West 12200 South Draper. Utah 84020
Re: K994370
Trade Name: Ortho Development Balanced KneerM System Regulatory Class: II Product Code: JWH Dated: December 23, 1999 Received: December 27, 1999
Dear Ms. Freasier:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general control provisions of the Act. The general control provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
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Page 2 - Ms. Carol Freasier
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device. please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Styph Ruoch
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Device Name: Balanced Knee™ System
Indications for Use
The Balanced Knee™ System is intended for single use in primary total knee replacement only. Indications include:
- 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; .
- . Moderate valgus, varus, or flexion deformities.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign-Off) · livision of General Restorative 994370 510(k) Number .
Prescription Use (Per 21 CFR 801.109)
OR
Over-The Courter Use (Optional Format 1-2-96)