(105 days)
Not Found
No
The device description focuses on the mechanical components and design of a knee implant, with no mention of software, algorithms, or data processing that would indicate AI/ML. The performance studies are based on preclinical testing and equivalence to predicate devices, not on the performance of an AI/ML algorithm.
Yes.
The device is indicated for the reduction or relief of pain and/or improved knee function in patients with severe knee pain and disability, which aligns with the definition of a therapeutic device.
No
This device is a total knee system, which is an implant used in knee arthroplasty to replace damaged knee joints. It is a treatment device, not one used for diagnosis.
No
The device description clearly outlines physical components (femoral component, tibial tray, patellar component) made of materials like polymer, indicating it is a hardware medical device, not software-only.
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 knee joint to alleviate pain and improve function in patients with various knee conditions. This is a therapeutic intervention performed in vivo (within the body).
- Device Description: The description details the physical components of a knee prosthesis (femoral component, tibial tray, patellar component) designed for surgical implantation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is a surgical implant used in vivo.
N/A
Intended Use / Indications for Use
The Progressive Orthopaedic Company Total Knee System II 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 arthrius, 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 Progressive Orthopaedic Company Total Knee System II 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 Company Total Knee System II is designed for cemented use only.
Product codes (comma separated list FDA assigned to the subject device)
JWH
Device Description
The Progressive Orthopaedic Company Total Knee System II is a fixed bearing implant available in posteriorstabilized (PS) and cruciate-retaining (CR) configurations. It is a patellofemorotibial, polymer, semi-constrained, cemented knee prosthesis that consists of a femoral component, tibial tray and patellar component. The PS 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 CR version of The Progressive Orthopaedic Company Total Knee System II 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 femoral component articulates with the tibial insert component. The underside of the tibial insert component is flat and "snaps" into tibial baseplate component. The design and sizing of the femoral components correspond to the natural femoral anatomy, enhancing stress distribution and restoring original femoral dimensions and normal rotation, extension and flexion. 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 shape of each patellar component also simplifies implantation by eliminating the need for rotational orientation.
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)
Extensive preclinical performance testing was conducted for the predicate devices (K142649 and K150783). The subject device components are identical to the predicate device, and the predicate device testing demonstrates substantial equivalence. The results confirm that all components of The Progressive Orthopaedic Company Total Knee System II exhibit the appropriate mechanical characteristics for total knee joint replacement.
Performance tests include:
- Fatigue performance of the tibial tray
- Interlock mechanism strength of the tibial tray and insert
- Shear fatigue strength of the tibial insert post
- Tibiofemoral contact area and stress
- Tibiofemoral constraint
- Patellofemoral constraint
- Range of motion
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.
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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 18, 2019
The Progressive Orthopaedic Company, LLC. Brad Harris CEO 10190 Riverside Drive, Suite 102 Palm Beach Gardens, Florida 33410
Re: K183344
Trade/Device Name: The Progressive Orthopaedic Company Total Knee System II Regulation Number: 21 CFR 888.3560 Regulation Name: Knee Joint Patellofemorotibial Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: JWH Dated: February 8, 2019 Received: February 14, 2019
Dear Brad Harris:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Digitally signed by Peter G. Peter G. Allen -S Date: 2019.03.18 Allen -S 20:47:35 -04'00'
Mark N. Melkerson FOR Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K183344
Device Name
The Progressive Orthopaedic Company Total Knee System II
Indications for Use (Describe)
The Progressive Orthopaedic Company Total Knee System II 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 arthrius, 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 Progressive Orthopaedic Company Total Knee System II 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 Company Total Knee System II is designed for cemented use only.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
[X] Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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6. 510(k) Summary
The following 510(k) Summary is provided in accordance with 21 CFR 807.92.
6.1 510(k) Owner and Registration
| Owner's Name: | The Progressive Orthopaedic Company, LLC. |
|---|---|
| Address: | 10190 Riverside Drive, Palm Beach Gardens, FL 33410 |
| Phone Number: | (561) 440-4460 |
| Fax Number: | (877) 299-6013 |
| Date Summary Prepared: | November 30, 2018 |
| Establishment Registration Number: | N/A |
510(k) Contact 6.2
| Contact: | Brad Harris |
|---|---|
| Address: | 10190 Riverside Drive, Palm Beach Gardens, FL 33410 |
| Phone Number: | (561) 602-3596 |
| Fax Number: | (877) 299-6013 |
| Contact Person: | Brad Harris |
Device Name and Classification 6.3
| Device Trade Name: | The Progressive Orthopaedic Company Total Knee
System II |
|------------------------------------|-------------------------------------------------------------|
| Device Common Name: | Total Knee Replacement |
| Regulation Number and Description: | 21 CFR 888.3560 |
| Device Class: | Class II |
| Product Codes: | JWH |
| Advisory Panel: | 87 (Orthopedic) |
Legally Marketed Predicate 6.4
The Progressive Orthopaedic Company Total Knee System II is utilizing the Progressive Orthopaedic Total Knee System as the predicate device (K142649/K150783). The Progressive Orthopaedic Company Total Knee System II features component designs, materials, indications, and manufacturing methods that are identical to the Progressive Orthopaedic Total Knee System.
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6.5 Device Description
The Progressive Orthopaedic Company Total Knee System II is a fixed bearing implant available in posteriorstabilized (PS) and cruciate-retaining (CR) configurations. It is a patellofemorotibial, polymer, semi-constrained, cemented knee prosthesis that consists of a femoral component, tibial tray and patellar component. The PS 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 CR version of The Progressive Orthopaedic Company Total Knee System II 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 femoral component articulates with the tibial insert component. The underside of the tibial insert component is flat and "snaps" into tibial baseplate component. The design and sizing of the femoral components correspond to the natural femoral anatomy, enhancing stress distribution and restoring original femoral dimensions and normal rotation, extension and flexion. 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 shape of each patellar component also simplifies implantation by eliminating the need for rotational orientation.
6.6 Intended Use
The Progressive Orthopaedic Company Total Knee System II is identical to the predicate Progressive Orthopaedic Total Knee System. The indications for use are also identical.
The Progressive Orthopaedic Company Total Knee System II 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 Progressive Orthopaedic Company Total Knee System II 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 Company Total Knee System II is designed for cemented use only.
Summary of Technological Characteristics 6.7
The Progressive Orthopaedic Company Total Knee System II is identical to the predicate Progressive Orthopaedic Total Knee System. Both devices are manufactured from identical materials, possess the same sizes, and feature the same packaging and sterilization processes. Extensive preclinical testing was performed on the predicate devices per K142649 and K150783 and found substantially equivalent. The performance tests are listed below and used herein to establish substantial equivalence (Section 19 Performance Testing -Bench)
Given that the subject device is identical to the predicate, the substantially equivalent to the predicate systems (K142649/K150783).
6.8 Performance Testing
Extensive preclinical performance testing was conducted and substantial equivalence determined per K142649 and K150783. The components of the subject device are identical to the predicate device, and therefore the
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predicate device testing demonstrates substantial equivalence for the results confirm that all components of The Progressive Orthopaedic Company Total Knee System II exhibit the appropriate mechanical characteristics for total knee joint replacement, and are substantially equivalent to the predicate devices.
- Fatigue performance of the tibial tray
- . Interlock mechanism strength of the tibial tray and insert
- . Shear fatigue strength of the tibial insert post
- Tibiofemoral contact area and stress
- . Tibiofemoral constraint
- Patellofemoral constraint
- . Range of motion
6.9 Conclusions
The Progressive Orthopaedic Company Total Knee System II is identical to the predicate Progressive Orthopaedic Total Knee System. The same design features, materials, and indications for use as the predicate devices. The testing performed for the predicate that The Progressive Orthopaedic Company Total Knee System II is safe for clinical use.
The Progressive Orthopaedic Company Total Knee System II is substantially equivalent to the predicate device.