(90 days)
No
The document describes a mechanical knee implant system and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML. The performance studies focus on mechanical testing.
Yes
The device is a knee prosthesis indicated for the reduction or relief of pain and/or improved knee function in patients with severe knee pain and disability due to various arthritic conditions and post-traumatic configurations, which are therapeutic goals.
No
Explanation: The device described is a total knee replacement system, which is an implantable medical device used in orthopedic surgery to replace damaged knee joints. It is a treatment device, not a diagnostic one.
No
The device description clearly outlines physical components made of polymer and metal, indicating it is a hardware device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for knee arthroplasty to address pain and improve function in patients with various knee conditions. This is a therapeutic intervention, not a diagnostic test performed on samples from the body.
- Device Description: The device is described as a knee prosthesis consisting of physical components (femoral component, tibial insert, tibial tray, patellar component) designed to replace parts of the knee joint. This is consistent with a surgical implant.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, tissue, etc.) from the human body to provide information for diagnosis, monitoring, or screening.
Therefore, the Progressive Orthopaedic Total Knee System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Progressive Orthopaedic 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, postraumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy, moderate valgus, varus, or flexion deformities.
The Progressive Orthopaedic 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 Progressive Orthopaedic Total Knee System is designed for cemented use only.
Product codes
JWH
Device Description
The present 510k submission is for a cruciate retaining (CR) version of the Progressive Orthopaedic Total Knee System and a line extension of HC PS tibial inserts. The main predicate device (K142649) is a posterior stabilized (PS) version of the Progressive Orthopaedic 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 Progressive Orthopaedic 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 Progressive Orthopaedic Total Knee System is a Patellofemoral tibia, polymer / metal / polymer, semi-constrained, cemented knee prosthesis, consisting of a femoral component, tibial insert, 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 a range of sizes of the femoral component to be matched with up to one size up/down of the 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
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 Progressive Orthopaedic Total Knee System is substantially equivalent to the PS version of the Progressive Orthopaedic Total Knee System.
Key Metrics
Not Found
Predicate Device(s)
Progressive Orthopaedic Total Knee System (K142649), NovoKnee Total Knee System (K131398)
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized representation of a human figure in profile, with three overlapping faces suggesting a sense of community and support. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the figure, emphasizing the department's role and national scope.
June 23, 2015
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
The Progressive Orthopaedic Company, LLC. Mr. Thomas Smith Quality and Regulatory Consultant 801 US Highway 1, Suite B North Palm Beach, Florida 33408
Re: K150783 Trade/Device Name: Progressive Orthopaedic Total Knee System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH Dated: March 24, 2015 Received: March 25, 2015
Dear Mr. Smith:
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 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
1
Page 2 - Mr. Thomas Smith
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 Industry and Consumer Education 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. 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 Industry and Consumer Education 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 N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K150783
Device Name Progressive Orthopaedic Total Knee System
Indications for Use (Describe)
The Progressive Orthopaedic 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, postraumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy, moderate valgus, varus, or flexion deformities.
The Progressive Orthopaedic 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 Progressive Orthopaedic Total Knee System is designed for cemented use only.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
Image /page/3/Picture/0 description: The image shows the logo for The Progressive Orthopaedic Company. The logo features a blue hexagon with a white caduceus symbol inside. To the right of the hexagon, the words "The" and "Progressive" are written in black, with "Progressive" in a larger, bolder font. Below "Progressive", the words "Orthopaedic Company" are written in a smaller, lighter font.
510(k) Summary
| Applicant/Sponsor: | The Progressive Orthopaedic Company, LLC.
801 US Highway 1, Suite B
North Palm Beach, FL, 33408
(561) 440-4460 |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Thomas Smith
Quality and Regulatory Consultant
801 US Highway 1, Suite B
North Palm Beach, FL, 33408
(203) 641-3936 |
| DEVICE INFORMATION | |
| Proposed Trade Name: | Progressive Orthopaedic 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: | Progressive Orthopaedic Total Knee System (K142649)
NovoKnee Total Knee System (K131398) |
Device Description:
The present 510k submission is for a cruciate retaining (CR) version of the Progressive Orthopaedic Total Knee System and a line extension of HC PS tibial inserts. The main predicate device (K142649) is a posterior stabilized (PS) version of the Progressive Orthopaedic 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 Progressive Orthopaedic 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 Progressive Orthopaedic Total Knee System is a Patellofemorotibia, polymer / metal / polymer, semi-constrained, cemented knee prosthesis, consisting of a femoral component, tibial insert, 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
4
Image /page/4/Picture/0 description: The image contains the logo for The Progressive Orthopaedic Company. The logo consists of a blue hexagon with a white caduceus symbol inside, followed by the company name in black text. The word "The" is above the word "Progressive", and the words "Orthopaedic Company" are below the word "Progressive".
radius of curvature. Each tibial insert component is complimentarily shaped to conform to the femoral components. This allows a range of sizes of the femoral component to be matched with up to one size up/down of the 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 Progressive Orthopaedic 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 Progressive Orthopaedic 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 of surgery. The Progressive Orthopaedic Total Knee System is designed for cemented use only.
Summary of Technological Characteristics
The CR version of the Progressive Orthopaedic Total Knee System has the same intended use and indications as the PS version of the Progressive Orthopaedic 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 same as 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, The Progressive Orthopaedic Company believes that the CR version of the Progressive Orthopaedic Total Knee System is substantially equivalent to the PS version of the Progressive Orthopaedic 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 Progressive Orthopaedic Total Knee System is substantially equivalent to the PS version of the Progressive Orthopaedic Total Knee System.