(48 days)
No
The document describes a mechanical implant (tibial component and insert) for total knee replacement. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML. The focus is on the materials, design, and mechanical performance of the physical device.
Yes
The device is a component of a total knee replacement system, which aims to alleviate severe knee pain and disability, correct deformities, and treat conditions like arthritis and fractures, thereby providing therapeutic benefits to the patient.
No
The device is a knee implant designed for surgical replacement of a damaged knee joint, not for diagnosing medical conditions.
No
The device description clearly details physical components made of cobalt-chrome molybdenum and UHMWPE, which are hardware materials used in a knee implant. The summary also describes mechanical and functional testing of these physical components.
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 replacing parts of the knee joint due to various conditions like arthritis and deformities. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details the materials (cobalt-chrome molybdenum, UHMWPE) and design of a physical implant intended for surgical implantation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue), or to provide information for the diagnosis, prevention, or treatment of disease.
The device is a surgical implant used in total knee replacement procedures.
N/A
Intended Use / Indications for Use
The Freedom® Metal Backed Tibial Component consists of a cobalt-chrome molybdenum (CoCrMo) tray and a UHMWPE insert that are 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
The Maxx Orthopedics' Freedom Total Knee System is intended for cemented use only. This device is for single use only.
Product codes
JWH
Device Description
The Maxx Orthopedics' Freedom® Metal Backed Tibial Component and Ultra High Molecular Weight Polyethylene (UHMWPE) insert are compatible with the Maxx Orthopedics Freedom® Total Knee System subject of K082019. The Maxx Orthopedics' Freedom® Total Knee System subject of K082019 is comprised of a femoral component, tibial component and patella component.
The Freedom® Metal Backed Tibial Component and UHMWPE insert are intended to be used with the Freedom® Total Knee System. The proposed metal backed Tibial Component and UHMWPE insert will be used in place of the all-poly tibial component with the Freedom® Total Knee System.
The proposed metal backed tibial component consists of a cobalt-chromiummolybdenum tray, and the insert is made from UHMWPE. These components are intended for cemented application to replace the articulating surface of the proximal tibia in a measured resection.
The tibia base components are designed with a keel portion which extends into the proximal tibial medullary canal. The more distal portion of the tibial base has a flat plate that rests on the patient's tibial plateau region. On the underside of this plate are cement recesses allowing allow for cement interdigitation which helps to provide rotational stability. The Freedom® Knee tibial inserts have an interlocking relation to the tibial base. The Freedom® Knee femoral components articulate with the bearing base (proximal) surface of the tibial inserts. The articulating surface of these inserts is identical to the articulating surface of the all-poly liner components mentioned in the already cleared Freedom® Total Knee System (K082019).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee joint (proximal tibia, patellofemoral)
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 and in Section 8 demonstrates that the Freedom® Metal Backed Tibial 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® Metal Backed Tibial Component and the Freedom® Total Knee System according to the Class II Special Controls Guidance Document: Knee Joint Patellofemoral and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA. The verification and validation testing performed which demonstrated that the Metal Backed Tibial 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)
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
1. SPONSOR
Maxx Orthopedics, Inc. 2260 Butler Pike Suite 100 Plymouth Meeting, PA 19462
APR - 7 2009
Contact Person: Nach Dave Telephone: 732-718-1385
Date Prepared: March 26, 2009
2. DEVICE NAME
| Proprietary Name: | Freedom® Metal Backed Tibial Component |
|---|---|
| Common/Usual Name: | Metal-backed tibial component |
| Classification Name: | Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis. |
3. PREDICATE DEVICES
- . Exactech Optetrak Total Knee Tibial Components subject of K030686.
4. DEVICE DESCRIPTION
The Maxx Orthopedics' Freedom® Metal Backed Tibial Component and Ultra High Molecular Weight Polyethylene (UHMWPE) insert are compatible with the Maxx Orthopedics Freedom® Total Knee System subject of K082019. The Maxx Orthopedics' Freedom® Total Knee System subject of K082019 is comprised of a femoral component, tibial component and patella component.
The Freedom® Metal Backed Tibial Component and UHMWPE insert are intended to be used with the Freedom® Total Knee System. The proposed metal backed Tibial Component and UHMWPE insert will be used in place of the all-poly tibial component with the Freedom® Total Knee System.
The proposed metal backed tibial component consists of a cobalt-chromiummolybdenum tray, and the insert is made from UHMWPE. These components are intended for cemented application to replace the articulating surface of the proximal tibia in a measured resection.
1
The tibia base components are designed with a keel portion which extends into the proximal tibial medullary canal. The more distal portion of the tibial base has a flat plate that rests on the patient's tibial plateau region. On the underside of this plate are cement recesses allowing allow for cement interdigitation which helps to provide rotational stability. The Freedom® Knee tibial inserts have an interlocking relation to the tibial base. The Freedom® Knee femoral components articulate with the bearing base (proximal) surface of the tibial inserts. The articulating surface of these inserts is identical to the articulating surface of the all-poly liner components mentioned in the already cleared Freedom® Total Knee System (K082019).
5. INTENDED USE
The Freedom® Metal Backed Tibial Component consists of a cobalt-chrome molybdenum (CoCrMo) tray and a UHMWPE insert that are 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. .
The Maxx Orthopedics' Freedom Total Knee System is intended for cemented use only. This device is for single use only.
6. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE
The proposed Maxx Orthopedics' Freedom® Metal Backed Tibial Component and the predicate devices are identical in that they all consist of a cobalt-chrome molybdenum (CoCrMo) tray and a UHMWPE insert.
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 tibial tray and insert sizes that are intended to mimic normal human anatomy. The articulating 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
2
devices are made of biocompatible materials and are technological designed and identical in materials.
7. PERFORMANCE TESTING
Mechanical and functional testing described in K082019 and in Section 8 demonstrates that the Freedom® Metal Backed Tibial 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® Metal Backed Tibial Component and the Freedom® Total Knee System according to the Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA. The verification and validation testing performed which demonstrated that the Metal Backed Tibial Component functions as intended and is safe and effective for its intended use.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure.
APR - 7 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Maxx Orthopedics, Inc. % Mary McNamara-Cullinane, RAC Senior Regulatory Consultant Medical Device Consultants, Inc. 49 Plain Street North Attleboro, Massachusetts 02760
Re: K090411
Trade/Device Name: Freedom Total Knee Metal Backed Tibial Components Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulation Class: Class II Product Code: JWH Dated: March 26, 2009 Received: March 27, 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. Ilsting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your 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 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); good manufacturing practice requirements as set
4
Page 2 - Mary McNamara-Cullinane, RAC
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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson
Director Division of General. Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K090411
Device Name: Maxx Orthopedics' Freedom® Metal Backed Tibial Component
Indications for Use:
The Freedom® Metal Backed Tibial Component consists of a cobalt-chrome molybdenum (CoCrMo) tray and a UHMWPE insert that are 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
The Maxx Orthopedics' Freedom Total Knee System 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)
Charlane Phillips
Division of General, Restorative, and Neurological Devices
510(k) Number K090411/5001