(161 days)
No
The device description and performance studies focus on the mechanical properties and design of a knee implant system, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is indicated for knee arthroplasty for 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
The device is a knee implant system used for knee arthroplasty, which is a surgical procedure to replace or augment parts of the knee joint. It is a treatment device, not a diagnostic one.
No
The device description explicitly states it is a cobalt-chromium-molybdenum (Co-Cr-Mo) metallic baseplate with various components, indicating it is a physical implant, not software.
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 various musculoskeletal conditions. This is a therapeutic intervention performed in vivo (within the body).
- Device Description: The device is described as a metallic baseplate with components like augments, stems, and inserts, designed to be implanted into 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 derived from the human body (like blood, urine, or 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 CPM Medical Consultants Tibial Revision 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 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 device is intended for use in patients who require augmentation and/or stem extensions due to inadequate bone stock and/or require constrained stabilization for tibiofemoral joint due to soft tissue in-balance. The tibial augments are to be attached to their respective components with a fixation screw or screws.
The CPM Medical Consultants Tibial Revision 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 CPM Medical Consultants Tibial Revision Knee System is designed for cemented use only.
The CPM Medical Consultants Tibial Revision Knee System is to be used in conjunction with the Progressive Orthopaedic Company Total Knee System cleared via K142649 & K150783.
Product codes
JWH
Device Description
The CPM Medical Consultants Tibial Revision Knee System is an extended design of The Modal Manufacturing Total Knee System (K142649/K150783). It is a cobalt-chromium-molybdenum (Co-Cr-Mo) metallic baseplate with a variety of components including tibial augments, stems, and offset adapters that provide more choice for surgeon treatment of their patients. The CPM Medical Consultants posterior stabilized plus inserts is a line extension to the previously cleared Modal Manufacturing posterior stabilized tibial insert (K142649). The CPM Medical Consultants Tibial Revision Knee System is to be used in conjunction with the previously cleared Modal Manufacturing Total Knee System (K142649/K150783) which is a fixed bearing implant available in posterior-stabilized (PS) and cruciate-retaining (CR) configurations. It is a patellofemorotibial, polymer/metal/polymer, semi-constrained, cemented knee prosthesis that consists of a femoral component, tibial insert, 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 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 femoral component articulates with the tibial insert component. The underside of the tibial insert component is flat and "snaps" into the 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, 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 rotation.
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 on the CPM Medical Consultants Tibial Revision Knee System and substantial equivalence to the predicate device was determined. The subject device are similar to the predicate device, and therefore the predicate device testing demonstrates substantial equivalence for the subject device. The results confirm that all components of the CPM Medical Consultants Tibial Revision Knee System exhibit the appropriate mechanical characteristics for tibial revision 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 utilizing Modal Manufacturing design and testing.
- Shear fatigue strength of the tibial insert post utilizing Modal Manufacturing design and testing.
- Tibiofemoral contact area and stress utilizing Modal Manufacturing design and testing.
- Tibiofemoral constraint utilizing Modal Manufacturing design and testing.
- Taper Lock Testing
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K142649, K150783, K082424, K122183
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/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 16, 2021
CPM Medical Consultants, LLC. Andy Rynearson Director of Engineering 1565 N. Central Expressway Richardson, Texas 75080
Re: K210695
Trade/Device Name: CPM Medical Consultants Tibial Revision 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: May 14, 2021 Received: May 18, 2021
Dear Andy Rynearson:
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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Ting Song, Ph.D., R.A.C. Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K210695
Device Name
CPM Medical Device Consultants Revision Tibial Knee System
Indications for Use (Describe)
The CPM Medical Consultants Tibial Revision 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 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 device is intended for use in patients who require augmentation and/or stem extensions due to inadequate bone stock and/or require constrained stabilization for tibiofemoral joint due to soft tissue in-balance. The tibial augments are to be attached to their respective components with a fixation screw or screws.
The CPM Medical Consultants Tibial Revision 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 CPM Medical Consultants Tibial Revision Knee System is designed for cemented use only.
The CPM Medical Consultants Tibial Revision Knee System is to be used in conjunction with the Progressive Orthopaedic Company Total Knee System cleared via K142649 & K150783. See below for a compatibility chart between systems.
Image /page/2/Figure/10 description: The image is a compatibility chart for CPM Medical Consultants Tibial Revision Components and Progressive Orthopaedic Company Components. The chart shows the compatibility between PS+ Tibial Insert, Tibial Stem, Tibial Augments, and Revision Tibial Tray with CR Femoral, PS Femoral, CR Tibial Insert, PS Tibial Insert, Tibial Tray, and Patella. Green indicates compatibility, while red indicates non-compatibility. For example, PS Femoral is compatible with PS+ Tibial Insert, and Tibial Tray is compatible with PS+ Tibial Insert and Revision Tibial Tray.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
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:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary
The following 510(k) Summary is provided in accordance with 21 CFR 807.92.
510(k) Owner and Registration
| Owner's Name: | CPM Medical Consultants, LLC. |
|---|---|
| Address: | 1565 N. Central Expressway, Suite 200, Richardson, |
| TX 75080 | |
| Phone Number: | (321) 316-2601 |
| Fax Number: | N/A |
| Date Summary Prepared: | April 30, 2021 |
| Establishment Registration Number: | N/A |
510(k) Contact
| Contact: | Andy Rynearson |
|---|---|
| Address: | 1565 N. Central Expressway, Suite 200, Richardson, |
| TX 75080 | |
| Phone Number: | (321) 316-2601 |
| Fax Number: | N/A |
| Contact Person: | Andy Rynearson |
Device Name and Classification
| Device Trade Name: | CPM Medical Consultants Revision Tibial Knee System |
|---|---|
| Device Common Name: | Revision Tibial Knee Replacement |
| Regulation Number and Description: | 21 CFR 888.3560 |
| Device Class: | Class II |
| Product Codes: | JWH |
| Advisory Panel: | 87 (Orthopedic) |
Legally Marketed Predicate
CPM Medical Consultants is utilizing the Modal Manufacturing Total Knee System, previously cleared as the Progressive Orthopaedic Company Total Knee System (K142649/K150783), and the United Orthopedic Corporation U2 Total Knee System as the predicate devices (K082424/K122183). The CPM Medical Consultants Tibial Revision Knee System features component designs, materials, indications, and manufacturing methods that are similiar to the Modal Manufacturing Total Knee System and the United Orthopedic Corporation U2 Total Knee System. The CPM Medical Consultants Revision Tibial Knee System is be used in conjunction with the previously cleared Progressive Orthopaedics/Modal to Manufacturing Total Knee System (K142649/K150783).
4
Device Description
The CPM Medical Consultants Tibial Revision Knee System is an extended design of The Modal Manufacturing Total Knee System (K142649/K150783). It is a cobalt-chromium-molybdenum (Co-Cr-Mo) metallic baseplate with a variety of components including tibial augments, stems, and offset adapters that provide more choice for surgeon treatment of their patients. The CPM Medical Consultants posterior stabilized plus inserts is a line extension to the previously cleared Modal Manufacturing posterior stabilized tibial insert (K142649). The CPM Medical Consultants Tibial Revision Knee System is to be used in conjunction with the previously cleared Modal Manufacturing Total Knee System (K142649/K150783) which is a fixed bearing implant available in posterior-stabilized (PS) and cruciate-retaining (CR) configurations. It is a patellofemorotibial, polymer/metal/polymer, semi-constrained, cemented knee prosthesis that consists of a femoral component, tibial insert, 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 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 femoral component articulates with the tibial insert component. The underside of the tibial insert component is flat and "snaps" into the 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, 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 rotation.
Intended Use
The CPM Medical Consultants Tibial Revision 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 device is intended for use in patients who require augmentation and/or stem extensions due to inadequate bone stock and/or require constrained stabilization for tibiofemoral joint due to soft tissue in-balance. The tibial augments are to be attached to their respective components with a fixation screw or screws.
The CPM Medical Consultants Tibial Revision 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 CPM Medical Consultants Tibial Revision Knee System is designed for cemented use only.
The CPM Medical Consultants Tibial Revision Knee System is to be used in conjunction with the Progressive Orthopaedic Company Total Knee System cleared via K142649 & K150783. See below for a compatibility chart between systems.
5
| | | CPM Medical Consultants Tibial Revision
Components | | | |
|-----------------------------------------------------|---------------------|-------------------------------------------------------|-------------|-----------------|----------------------|
| | | PS+ Tibial Insert | Tibial Stem | Tibial Augments | Revision Tibial Tray |
| Progressive
Orthopaedic
Company
Components | CR
Femoral | | | | |
| | PS
Femoral | | | | |
| | CR Tibial
Insert | | | | |
| | PS Tibial
Insert | | | | |
| | Tibial
Tray | | | | |
| | Patella | | | | |
Compatibility Chart
Summary of Technological Characteristics
The CPM Medical Consultants Tibial Revision Knee System is similiar to the predicate Modal Manufacturing 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 subject system is substantially equivalent to the predicate systems (K142649/K150783).
Performance Testing
Extensive preclinical performance testing was conducted on the CPM Medical Consultants Tibial Revision Knee System and substantial equivalence to the predicate device was determined. The subject device are similar to the predicate device, and therefore the predicate device testing demonstrates substantial equivalence for the subject device. The results confirm that all components of the CPM Medical Consultants Tibial Revision Knee System exhibit the appropriate mechanical characteristics for tibial revision 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 utilizing Modal Manufacturing design and testing.
- Shear fatigue strength of the tibial insert post utilizing Modal Manufacturing design and testing.
6
- Tibiofemoral contact area and stress utilizing Modal Manufacturing design and testing.
- Tibiofemoral constraint utilizing Modal Manufacturing design and testing.
- Taper Lock Testing
Conclusions
The subject device has the same design features, materials, and indications for use as the predicate devices. The testing performed for the predicate device indicates that the CPM Medical Consultants Tibial Revision Knee System is safe for clinical use.
The CPM Medical Consultants Tibial Revision Knee System is substantially equivalent to the predicate device.