(124 days)
Not Found
No
The summary describes a mechanical knee implant system and its components. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML. The performance studies focus on mechanical testing of the implant components.
Yes
The device is a knee arthroplasty system indicated for the reduction or relief of pain and improvement of knee function in patients with severe knee pain and disability, which aligns with the definition of a therapeutic device.
No
Explanation: The NovoKnee Total Knee System is a total knee replacement prosthesis, used for treating severe knee pain and disability. It is an implantable medical device designed to replace parts of the knee joint, not to diagnose a condition.
No
The device description clearly outlines physical components (femoral component, tibial tray, patellar component, tibial insert) made of materials like polymer, indicating it is a hardware device, not software-only.
Based on the provided information, the NovoKnee Total Knee System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used in the body for surgical implantation to replace a damaged knee joint. IVDs are used outside the body to examine specimens (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The description details physical components (femoral component, tibial tray, patellar component) designed to be surgically implanted. This is consistent with a medical device, not an IVD.
- Anatomical Site: The device is used in the "Knee joint," which is an anatomical location within the body. IVDs analyze samples taken from the body.
- Performance Studies: The performance studies described (contact area, shear tests) are related to the mechanical integrity and function of the implant, not the analysis of biological specimens.
Therefore, the NovoKnee Total Knee System is a medical device intended for surgical implantation, not an In Vitro Diagnostic.
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 present 510k submission is for a cruciate retaining (CR) version of the NovoKnee Total Knee System. The main predicate device ([K123339](https://510k.innolitics.com/search/K123339)) is a posterior stabilized (PS) version of the NovoKnee Total Knee System. All implant components are the same between the two versions, except for the tibial inserts and the femoral components. The posterior stabilized version has tibial inserts with posts and femoral components with cams that interact with the posts to help stabilize the knee after the posterior cruciate ligament is removed. The cruciate retaining version of the NovoKnee Total Knee System has tibial inserts and femoral components without posts or cams, allowing the posterior cruciate ligament to be "retained" and provide stability to the knee joint.
The NovoKnee Total Knee System is a Patellofemorotibia, 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 fernoral 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 following tests were performed in this submission:
1. Femoral/Tibial Insert Contact Area Test;
2. Anterior Shear Test of Insert/Tray Interlocking Mechanism;
3. Posterior Shear Test of Insert/Tray Interlocking Mechanism; and
4. Medial/Lateral Shear Test of Insert/Tray Interlocking Mechanism.
Test results indicate that the CR version of the NovoKnee Total Knee System is substantially equivalent to the PS version of the NovoKnee Total Knee System.
# 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.
[K123339](https://510k.innolitics.com/search/K123339), [K051640](https://510k.innolitics.com/search/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
Image /page/0/Picture/0 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 "NovoSource" is a circle containing the letters "Ns". Below the word "NovoSource" is the text "K131398 (1/2)".
510(k) Summary
Applicant/Sponsor:
NovoSource, Inc. 714 East Monument Ave. Suite 220 Dayton, OH, 45402 937-531-6591
Contact Person:
David Letteri Vice President of Quality and Regulatory NovoSource, Inc. 714 East Monument Ave. Suite 220 Dayton, OH, 45402 937-531-6591
SEP 16 2013
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: | NovoKnee Total Knee System (K123339) |
| United Orthopedic U2 Total Knee (K051640) |
Device Description:
The present 510k submission is for a cruciate retaining (CR) version of the NovoKnee Total Knee System. The main predicate device (K123339) is a posterior stabilized (PS) version of the NovoKnee Total Knee System. All implant components are the same between the two versions, except for the tibial inserts and the femoral components. The posterior stabilized version has tibial inserts with posts and femoral components with cams that interact with the posts to help stabilize the knee after the posterior cruciate ligament is removed. The cruciate retaining version of the NovoKnee Total Knee System has tibial inserts and femoral components without posts or cams, allowing the posterior cruciate ligament to be "retained" and provide stability to the knee joint.
The NovoKnee Total Knee System is a Patellofemorotibia, 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
1
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 fernoral 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.
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 CR version of the NovoKnee Total Knee System has the same intended use and indications as the PS version of the NovoKnee Total Knee System. The CR version is manufactured from the same materials as the PS version. The range of sizes available for the CR version is the range of sizes of the PS version. The CR version design is substantially similar to the PS version system design. Based on these similarities, NovoSource believes that the CR version of the NovoKnee Total Knee System is substantially equivalent to the PS version of the NovoKnee Total Knee System.
Performance Testing
The following tests were performed in this submission:
-
- Femoral/Tibial Insert Contact Area Test;
-
- Anterior Shear Test of Insert/Tray Interlocking Mechanism;
-
- Posterior Shear Test of Insert/Tray Interlocking Mechanism; and
-
- Medial/Lateral Shear Test of Insert/Tray Interlocking Mechanism.
Test results indicate that the CR version of the NovoKnee Total Knee System is substantially equivalent to the PS version of the NovoKnee Total Knee System.
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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 or bird-like symbol with three curved lines representing its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
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
September 16, 2013
NovoSource, Incorporated % Mr. James Pinkston IMDS Corporation 560 West Golf Course Road Providence, Utah 84332
Re: K131398
Trade/Device Name: NovoKnee Total Knee System Regulation Number: 21 CFR 888.3560 Regulation Name: Knec joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH Dated: August 1, 2013 Received: August 2, 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, labcling, 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 complics 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 801); medical device reporting (reporting of medical
3
Page 2 - Mr. James Pinkston
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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/ReportalProblem/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.
Sincercly yours.
Elizabeth L. Frank -S
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
K131398 510(k) Number (if known):
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)
Page 1 of _1
Casey L. Hanley, Ph.D.
Division of Orthopedic Devices