(162 days)
Not Found
No
The summary describes a mechanical knee implant system and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is indicated for the reduction or relief of pain and improved knee function in patients with severe knee pain and disability due to various conditions, indicating a therapeutic purpose.
No
Explanation: The device is a total knee replacement system, which is a prosthetic implant used for surgical intervention, not for diagnosing medical conditions. Its intended use is to reduce pain and improve knee function in patients with severe knee issues.
No
The device description clearly states it is a physical knee prosthesis consisting of metal and polymer components.
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 replacing a damaged knee joint. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details the physical components of a knee prosthesis (femoral component, tibial tray, patellar component). These are physical implants, not reagents, instruments, or systems used to examine specimens from the human body.
- No mention of biological specimens: There is no indication that this device interacts with or analyzes biological samples (blood, urine, tissue, etc.).
- Performance Studies: The performance studies focus on the mechanical properties and durability of the implant, which is typical for a surgical device.
IVD devices are used to diagnose diseases or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. This device does not fit that description.
N/A
Intended Use / Indications for Use
Total knee arthroplasty
The NovoKnee Total Knee System is indicated in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with severe knee pain and disability due to rheumatoid arthritis, osteoarthritis, primary and secondary traumatic arthritis, collagen disorders, avascular necrosis of the femoral condyle or pseudogout, posttraumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy, moderate valgus, varus, or flexion deformities. The NovoKnee Total Knee System may also be indicated in the salvage of previously failed surgical attempts if the knee can be satisfactorily balanced and stabilized at the time of surgery. The NovoKnee Total Knee System is designed for cemented use only.
Product codes (comma separated list FDA assigned to the subject device)
JWH
Device Description
The NovoKnee Total Knee System is of the fixed bearing type with a posterior stabilized design. It is a Patellofemorotibia, polymer/metal/polymer, semi-constrained, cemented knee prosthesis, that consists of a femoral component, tibial tray and patellar component. The femoral component articulates with the tibial insert component. The underside of the tibial insert component is flat and "snaps" into the tibial baseplate component. Each femoral component has the same intercondylar distance and radius of curvature. Each tibial insert component is complimentarily shaped to conform to the femoral components. This allows any size femoral component to be matched with any size tibial component. The dome shape of each UHMWPE patellar component provides excellent contact with the femoral component and evenly distributes stresses. The dome and sombrero shape of each UHMWPE patellar component provides contact with the femoral component.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee
Indicated Patient Age Range
skeletally mature patients
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)
The NovoKnee Total Knee System was tested for fatigue performance of the tibial tray, interlock mechanism strength (between the tibial tray and tibial insert), shear fatigue strength of the tibial insert post, femoral/tibial insert contact pressures and areas, lateral subluxation of patellar component, and range of motion performance. Test results indicate that the NovoKnee Total Knee System is equivalent to the U2 Total Knee System and is capable of withstanding expected in vivo loading without failure.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
U2 Total Knee System (K051640)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
K123339
Image /page/0/Picture/1 description: The image shows the logo for NovoSource. The logo is in black and white and features the word "NovoSource" in a bold, sans-serif font. To the right of the word is a circle containing the letters "Ns".
510(k) Summary
APR 1 1 2013
Applicant/Sponsor:
NovoSource, Inc. 714 East Monument Ave. Suite 219 Dayton, OH, 45402 937-531-6591
Contact Person:
David Letteri VP, Quality and Regulatory at NovoSource, Inc. NovoSource, Inc. 714 East Monument Ave. Suite 219 Dayton, OH, 45402 937-531-6591
Date Prepared:
October 30, 2012
DEVICE INFORMATION
| Proposed Trade Name: | NovoKnee Total Knee System |
|---|---|
| Common Name: | Semi-constrained total knee prosthesis |
| Classification Name: | Knee joint patellofemorotibial polymer/metal/polymer semi- |
| constrained cemented prosthesis per 21CFR 888.3560. This falls under | |
| the Orthopedics panel/87 as a Class II device. | |
| Device Product Code: | JWH |
| Predicate Device: | U2 Total Knee System (K051640) |
Device Description:
The NovoKnee Total Knee System is of the fixed bearing type with a posterior stabilized design. It is a Patellofemorotibia, polymer/metal/polymer, semi-constrained, cemented knee prosthesis, that consists of a femoral component, tibial tray and patellar component. The femoral component articulates with the tibial insert component. The underside of the tibial insert component is flat and "snaps" into the tibial baseplate component. Each femoral component has the same intercondylar distance and radius of curvature. Each tibial insert component is complimentarily shaped to conform to the femoral components. This allows any size femoral component to be matched with any size tibial component. The dome shape of each UHMWPE patellar component provides excellent contact with the femoral component and evenly distributes stresses. The dome and sombrero shape of each UHMWPE patellar component provides contact with the femoral component.
Page 1 of 2
1
Intended Use:
Total knee arthroplasty
Indications for Use:
The NovoKnee Total Knee System is indicated in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with severe knee pain and disability due to rheumatoid arthritis, osteoarthritis, primary and secondary traumatic arthritis, collagen disorders, avascular necrosis of the femoral condyle or pseudogout, posttraumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy, moderate valgus, varus, or flexion deformities. The NovoKnee Total Knee System may also be indicated in the salvage of previously failed surgical attempts if the knee can be satisfactorily balanced and stabilized at the time of surgery. The NovoKnee Total Knee System is designed for cemented use only.
Summary of Technological Characteristics
The NovoKnee Total Knee System has the same intended use and indications as the U2 Total Knee system. The NovoKnee Total Knee System is manufactured from the same, or equivalent, materials as the U2 Total Knee system. The range of sizes available for the NovoKnee Total Knee System is the same as the range of sizes of the U2 Total Knee system. The NovoKnee Total Knee System design is substantially similar to the U2 Total Knee system design. Based on these similarities, NovoSource believes that the NovoKnee Total Knee System is substantially equivalent to the U2 Total Knee system.
Performance Testing
The NovoKnee Total Knee System was tested for fatigue performance of the tibial tray, interlock mechanism strength (between the tibial tray and tibial insert), shear fatigue strength of the tibial insert post, femoral/tibial insert contact pressures and areas, lateral subluxation of patellar component, and range of motion performance. Test results indicate that the NovoKnee Total Knee System is equivalent to the U2 Total Knee System and is capable of withstanding expected in vivo loading without failure.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image contains the words "Public Health Service" in a simple, sans-serif font. The text is arranged horizontally, with each word clearly legible. The overall impression is clean and straightforward, suggesting an official or institutional context.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Letter dated: April 11, 2013
NovoSource. Incorporated % IMDS Corporation Mr. James Pinkston Regulatory Consultant 124 South 600 West Logan, Utah 84321
Re: K123339
Trade/Device Name: NovoKnee Total Knee System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee Joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH Dated: January 28, 2013 Received: March 13, 2013
Dear Mr. Pinkston:
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. 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
3
Page 2 – Mr. James Pinkston
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Mark Nigelkerson -S
Mark Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K123339
Device Name: NovoKnee Total Knee System
Indications for Use:
The NovoKnee Total Knee System is indicated in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with severe knee pain and disability due to rheumatoid arthritis, osteoarthritis, primary and secondary traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral condyle or pseudogout. posttraumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy, moderate valgus, varus, or flexion deformities. The NovoKnee Total Knee System may also be indicated in the salvage of previously failed surgical attempts if the knee can be satisfactorily balanced and stabilized at the time of surgery. The NovoKnee Total Knee System is designed for cemented use only.
Prescription Use X (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)
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Casev Division of Orthopaed Devices