(147 days)
No
The summary describes a mechanical knee implant component and its intended use, with no mention of software, algorithms, or any technology related to AI or ML.
Yes
The device is a component of a total knee system intended to alleviate severe knee joint pain, loss of mobility, and disability by replacing parts of the joint, which constitutes a therapeutic purpose.
No
The device is a knee implant designed for therapeutic purposes, such as replacing the articulating surface of the distal femur and addressing severe knee pain or deformities. It does not provide information or diagnose a medical condition.
No
The device description clearly states it is a cobalt-chromium molybdenum (CoCrMo) femoral component, which is a physical hardware implant.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions.
- Device Description and Intended Use: The description clearly states that this device is a femoral component designed to be used in total knee replacement surgery. It is a physical implant intended to replace a part of the knee joint.
- Lack of Diagnostic Activity: There is no mention of this device being used to analyze biological samples or provide diagnostic information about a patient's condition. Its purpose is therapeutic and structural, not diagnostic.
Therefore, the Freedom® Total Knee Cruciate Retaining (CR) Femoral Component is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Freedom® Total Knee Cruciate Retaining (CR) Femoral Component consists of a cobalt-chromium molybdenum (CoCrMo) femoral component designed to be used with the Freedom® Total Knee System, and the Freedom® Total Knee Metal Backed Tibial Components. The Freedom Total Knee System is indicated for the following:
- Severe knee joint pain, loss of mobility, and disability due to: rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
- Correction of functional deformities,
- Post-traumatic loss of knee joint contour, particularly when there is patellofemoral erosion, dysfunction, and/or prior patellectomy.
- Moderate valgus, varus, or flexion trauma.
- Knee fractures untreatable by other methods
The Freedom® Total Knee Cruciate Retaining (CR) Femoral Component is intended for cemented use only. This device is for single use only.
Product codes
JWH
Device Description
The Maxx Orthopedics' Freedom® CR Femoral Component is compatible with the Maxx Orthopedics Freedom® Total Knee System subject of K082019 and the Metal Backed Tibial Component subject of K090411. The Maxx Orthopedics' Freedom® Total Knee System subject of K082019 is comprised of a femoral component, tibial component and patella component.
The proposed Freedom® CR Femoral Component consist of a cobalt-chromium molybdenum (CoCrMo) component that is designed to be used with the Freedom® Total Knee System described in K082019 and the Freedom Metal Backed Tibial Component subject of K090411. The Maxx Orthopedics' Freedom® Total Knee System subject of K082019 is comprised of a femoral component (posterior stabilizing), an all-poly tibial component, and a patellar component. The Freedom Metal Backed Tibial Component subject of K090411 consists of a metal backed tibial component and polyethylene insert. The proposed CR Femoral Component will provide the surgeon with an alternative femoral component in the event that the surgeon prefers to use a CR component rather than the PS component with the Freedom® Total Knee System. In addition, a second metal backed tibial component was cleared for use with the Freedom Total Knee System under K090411. The proposed CR Femoral Component and a (UHMWPE) insert will be used in place of the PS Femoral component with the Freedom® Total Knee System.
The CR Femoral Component of the Freedom® Total Knee System CR is designed to replace the articulating surface of the distal femur. The cruciate retaining femoral component is utilized when total knee replacement is indicated, and accommodates the posterior cruciate ligament if it is present.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee joint / distal femur
Indicated Patient Age Range
Not Found
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)
Mechanical and functional testing described in K082019, K090411 and in Section 8 demonstrates that the Freedom® CR Femoral Component are mechanically and functionally similar to the parent Freedom UHMWPE Tibial Component and other legally marketed knee systems. Evaluations were performed to determine the material and mechanical characteristics of the Maxx Orthopedics' Freedom® CR Femoral Component and the Freedom® Total Knee System according to the Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Fernorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA. The verification and validation testing have been performed which demonstrate that the CR Femoral Component functions as intended and is safe and effective for its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
K091280 p. 1 of 3
SEP 2 5 2009
510(k) Summary for
Freedom® Total Knee Cruciate Retaining (CR) Femoral Component
1. SPONSOR
Maxx Orthopedics, Inc. 2260 Butler Pike Suite 100 Plymouth Meeting, PA 19462
Contact Person: Nach Dave Telephone: 732-718-1385
Date Prepared: April 30, 2009
2. DEVICE NAME
| Proprietary Name: | Freedom® CR Femoral Component |
|---|---|
| Common/Usual Name: | Cruciate Retaining Total Knee Replacement |
| Classification Name: | Knee Joint Patellofemorotibial Polymer/Metal/Polymer |
| Semi-Constrained Cemented Prosthesis -21 CFR §888.3560 |
3. PREDICATE DEVICES
- · Freedom Total Knee system subject of K082019
- · Osteonics Scorpio Cruciate Retaining Total Knee System, subject of K974566
4. DEVICE DESCRIPTION
The Maxx Orthopedics' Freedom® CR Femoral Component is compatible with the Maxx Orthopedics Freedom® Total Knee System subject of K082019 and the Metal Backed Tibial Component subject of K090411. The Maxx Orthopedics' Freedom® Total Knee System subject of K082019 is comprised of a femoral component, tibial component and patella component.
The proposed Freedom® CR Femoral Component consist of a cobalt-chromium molybdenum (CoCrMo) component that is designed to be used with the Freedom® Total Knee System described in K082019 and the Freedom Metal Backed Tibial Component subject of K090411. The Maxx Orthopedics' Freedom® Total Knee System subject of K082019 is comprised of a femoral component (posterior stabilizing), an all-poly tibial
1
K091280 p.20+3
component, and a patellar component. The Freedom Metal Backed Tibial Component subject of K090411 consists of a metal backed tibial component and polyethylene insert. The proposed CR Femoral Component will provide the surgeon with an alternative femoral component in the event that the surgeon prefers to use a CR component rather than the PS component with the Freedom® Total Knee System. In addition, a second metal backed tibial component was cleared for use with the Freedom Total Knee System under K090411. The proposed CR Femoral Component and a (UHMWPE) insert will be used in place of the PS Femoral component with the Freedom® Total Knee System.
The CR Femoral Component of the Freedom® Total Knee System CR is designed to replace the articulating surface of the distal femur. The cruciate retaining femoral component is utilized when total knee replacement is indicated, and accommodates the posterior cruciate ligament if it is present.
5. INTENDED USE
The Freedom® CR Femoral Component consists of a cobalt-chromium molybdenum (CoCrMo) component that is designed to be used with the Freedom Total Knee System. The Maxx Orthopedics' Freedom® Total Knee System is indicated for patients with severe knee pain and disability due to:
- . Severe knee joint pain, loss of mobility, and disability due to: rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
- . Correction of functional deformities.
- · Post-traumatic loss of knee joint contour, particularly when there is patellofemoral erosion, dysfunction, and/or prior patellectomy.
- . Moderate valgus, varus, or flexion trauma.
- Knee fractures untreatable by other methods.
6. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE
The proposed Maxx Orthopedics' Freedom® CR Femoral Component and the predicate devices are identical in that they all consist of cobalt-chromium molybdenum (CoCrMo) material and are available in right and left cruciate retaining configurations.
Both the proposed component and the predicate devices have been designed to mimic the normal knee geometry. Both the proposed and predicate devices are available in a variety of sizes that are intended to mimic normal human anatomy. The articulating
2
surface of the proposed Maxx Orthopedics Freedom® femoral and tibial components, are similar to the articulating surface of the predicate systems and are functionally equivalent devices. Both the proposed and predicate devices are made of biocompatible materials and are technological designed and identical in materials.
7. PERFORMANCE TESTING
Mechanical and functional testing described in K082019, K090411 and in Section 8 demonstrates that the Freedom® CR Femoral Component are mechanically and functionally similar to the parent Freedom UHMWPE Tibial Component and other legally marketed knee systems. Evaluations were performed to determine the material and mechanical characteristics of the Maxx Orthopedics' Freedom® CR Femoral Component and the Freedom® Total Knee System according to the Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Fernorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA. The verification and validation testing have been performed which demonstrate that the CR Femoral Component functions as intended and is safe and effective for its intended use.
3
Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. Inside the circle is an abstract image of a bird-like figure.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002
SEP % 6 2009
Maxx Orthopedics, Inc. c/o Ms. Mary McNamara-Cullinane Senior Regulatory Consultant 49 Plain Street North Attleboro, Massachusetts 02760
Re: K091280
Trade/Device Name: FREEDOM® Total Knee Cruciate Retaining (CR) Femoral Component
Regulation Number: 21 CFR 888.3560
Regulation Name: Knee joint patellofemorotibial polymer semi-constrained cemented prosthesis
Regulatory Class: Class II
Product Code: JWH
Dated: July 24, 2009
Received: August 6, 2009
Dear Ms. McNamara-Cullinane:
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.
If vour device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 equiválence 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
4
Page 2 - Ms. Mary McNamara-Cullinane
CFR Part 807); labeling (21 CFR Part 801); 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Barbary Buettner
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K091280
Maxx Orthopedics' Freedom® Total Knee Cruciate Retaining (CR) Device Name: Femoral Component
Indications for Use:
The Freedom® Total Knee Cruciate Retaining (CR) Femoral Component consists of a cobalt-chromium molybdenum (CoCrMo) femoral component designed to be used with the Freedom® Total Knee System, and the Freedom® Total Knee Metal Backed Tibial Components. The Freedom Total Knee System is indicated for the following:
- Severe knee joint pain, loss of mobility, and disability due to: rheumatoid arthritis, ● osteoarthritis, traumatic arthritis, polyarthritis.
- Correction of functional deformities,
- Post-traumatic loss of knee joint contour, particularly when there is patellofemoral . erosion, dysfunction, and/or prior patellectomy.
- Moderate valgus, varus, or flexion trauma. .
- Knee fractures untreatable by other methods
The Freedom® Total Knee Cruciate Retaining (CR) Femoral Component is intended for cemented use only. This device is for single use only.
Prescription Use _X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY) Concurrence of CDRH, Office of Device Evaluation (ODE)
Sonta for mxu
(Division Sign On)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K091280