(101 days)
No
The summary describes a mechanical implant (femoral component for total knee replacement) and its mechanical and functional testing. There is no mention of AI, ML, image processing, or any software-driven analytical capabilities.
Yes.
The device is a knee implant designed to relieve severe knee joint pain, restore mobility, and correct deformities for patients suffering from various conditions, which are therapeutic goals.
No
The device is a knee implant designed for total knee replacement surgery, which is a treatment procedure, not a diagnostic one. Its purpose is to replace damaged knee joint surfaces, not to identify or diagnose medical conditions.
No
The device description clearly states that the components are "single use only, implantable devices" and are intended for use in total knee replacement surgery, indicating a physical, hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The description clearly states that the Freedom® Cementless Femoral Components are implantable devices used in total knee replacement surgery. They are physically placed inside the patient's body.
- Intended Use: The intended use describes the conditions for which the device is used as a surgical implant to replace damaged knee joint surfaces.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information based on in vitro testing.
Therefore, the Freedom® Cementless Femoral Components are a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Freedom® Cementless Femoral Components are designed to be used as a part of the Freedom® Total Knee System, and 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
- Revision surgery where sufficient bone stock and soft tissue integrity are present. ●
The Freedom Total Knee System, Freedom Stemmed Tibial Components and Freedom PCK Components are indicated for cemented fixation. Only Cementless Femoral (CR and PS) components with porous coating are additionally indicated for cementless biological fixation application.
Product codes
MBH
Device Description
The Cementless Femoral Components ("Components") are intended for use with the currently available Freedom Total Knee System as part of total knee replacement (TKR) surgery. Total knee replacement surgery is a procedure where worn, diseased, or damaged surfaces of the knee joint are removed and replaced with artificial surfaces.
The Components will be prescription products consisting of single use only, implantable devices for implanting into patients in an operating theatre by a qualified surgeon.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee joint
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Qualified surgeon / Operating theatre
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 Section 8 of this 510(k) submission demonstrates that the Freedom® Cementless Components are mechanically and functionally equivalent to the parent Freedom® Total Knee System. The evaluations were performed in accordance with the Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Cementless Prostheses; Guidance for Industry and FDA. The results were found to be equivalent to the legally marketed predicate device.
Test Name: Stereological Evaluation
Objective: The purpose of this study was to determine (1) percent porosity, (2) pore size (line length intercept), and (3) coating thickness of CoCr coupons coated and sintered with three layers of -40/+60 mesh CoCr powder. The interconnection of porosity was also examined on all coupons. The coating technique utilized in this study is identical to the coating technique used for specified medical implants.
Test Name: Static Shear and Tensile Testing
Test Name: Abrasion Testing
Test Name: Shear fatigue testing
Objective: The purpose of this study was to determine shear fatigue strength of ASTM F75 CoCr coupons coated and sintered with three layers of -40/+60 mesh CoCr powder. The coating technique utilized in this study is identical to the coating technique used for specified medical implants.
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
§ 888.3565 Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial metal/polymer porous-coated uncemented 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 is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra high molecular weight polyethylene tibial bearing is rigidly secured to the metal tibial base plate.(b)
Classification. Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.” See § 888.1 for the availability of this guidance.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized human figure with three heads, representing health, services, and people. The figure is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the figure.
June 26, 2015
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Maxx Orthopedics, Incorporated Ms. Gabriela Gottlieb Regulatory Affairs Manager 531 Plymouth Rd., Suite 526 Plymouth Meeting, Pennsylvania 19462
Re: K150680 Trade/Device Name: Freedom® Cementless Femoral Components Regulation Number: 21 CFR 888.3565 Regulation Name: Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: MBH Dated: March 16. 2015 Received: March 18, 2015
Dear Gabriela Gottlieb:
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
1
related adverse events) (21 CFR 803); 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 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/ResourcesforYou/Industry/default.htm. 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 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
Freedom® Cementless Femoral Components Device Name:
Indications for Use:
The Freedom® Cementless Femoral Components are designed to be used as a part of the Freedom® Total Knee System, and 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
- Revision surgery where sufficient bone stock and soft tissue integrity are present. ●
The Freedom Total Knee System, Freedom Stemmed Tibial Components and Freedom PCK Components are indicated for cemented fixation. Only Cementless Femoral (CR and PS) components with porous coating are additionally indicated for cementless biological fixation application.
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)
3
Section 13
510(k) Summary
Submitter:
Date of Summary: June 25, 2015
Maxx Orthopedics, Inc. 531 Plymouth Rd #526 Plymouth Meeting, PA 19462
Establishment Registration Number: 3007311878
| Contact Person: | Alternate Contact: |
|---|---|
| Gabriela Gottlieb | Nach Dave |
| Manager, Regulatory and Clinical Affairs | Director, Regulatory and Clinical Affairs |
| Phone: 215-606-7418 | Phone: 732-718-1385 |
| Email: gabriela.gottlieb@maxxortho.com | Email: nach.dave@maxxortho.com |
Device Information:
| Proprietary Name: | Freedom® Cementless Femoral Components |
|---|---|
| Common/Usual Name: | Cementless Femoral Components |
| Classification Name: | Knee Joint Patellofemorotibial Metal/Polymer porous-coated |
| Cementless prosthesis | |
| Regulation Number: | 21 CFR 888.3565 |
| Regulatory Class: | Class II |
| Product Code: | MBH |
Identification of Predicate Device(s):
The Freedom® Cementless Femoral Components are similar to the following commercially available devices in regards to the fundamental scientific technology, material composition and intended use:
| Device Name | Type | Device
Class | Product
Code | Regulation
Number | 510(k)
number |
|---------------------------------------------|-----------|-----------------|-----------------|----------------------|-------------------------------|
| Freedom Total Knee system | Primary | II | JWH | 21 CFR §
888.3560 | K082019
K091280
K131481 |
| Optetrak Logic® Porous Femoral
Component | Reference | II | MBH | 21 CFR §
888.3565 | K140302 |
4
Device Description:
The Cementless Femoral Components ("Components") are intended for use with the currently available Freedom Total Knee System as part of total knee replacement (TKR) surgery. Total knee replacement surgery is a procedure where worn, diseased, or damaged surfaces of the knee joint are removed and replaced with artificial surfaces.
The Components will be prescription products consisting of single use only, implantable devices for implanting into patients in an operating theatre by a qualified surgeon.
Intended Use:
The Freedom® Cementless Femoral Components are designed to be used as a part of the Freedom® Total Knee System, and 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
- Revision surgery where sufficient bone stock and soft tissue integrity are present.
The Freedom Total Knee System, Freedom Stemmed Tibial Components and Freedom PCK Components are indicated for cemented fixation. Only Cementless Femoral (CR and PS) components with porous coating are additionally indicated for cementless biological fixation application.
Substantial Equivalence for Technological Characteristics:
The proposed Maxx Orthopedics' Freedom® Cementless Femoral Component and the primary predicate device are identical in that they consist of same geometric design, material of composition, and intended use. The proposed components are also the same in fundamental scientific technology as the referenced predicate device (porous coating). The only difference is the device's operating mechanism, which is expanded to give the Surgeon the option to apply implant without cement.
Both the proposed Freedom® Cementless Femoral Components and the predicate devices have been designed to mimic the normal knee geometry. Both the proposed and predicate devices are compatible with left and right configurations and available in a variety of sizes that are intended to mimic normal human anatomy. Both the proposed and predicate devices are made of biocompatible materials and are identical in technological design and materials.
5
Performance Testing:
Mechanical and functional testing described in Section 8 of this 510(k) submission demonstrates that the Freedom® Cementless Components are mechanically and functionally equivalent to the parent Freedom® Total Knee System. The evaluations were performed in accordance with the Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Cementless Prostheses; Guidance for Industry and FDA. The results were found to be equivalent to the legally marketed predicate device.
| Test Name | Test # | Objective |
|---|---|---|
| Stereological | ||
| Evaluation | TR-15-01 | The purpose of this study was to determine (1) percent |
| porosity, (2) pore size (line length intercept), | ||
| and (3) coating thickness of CoCr coupons coated and | ||
| sintered with three layers of -40/+60 mesh | ||
| CoCr powder. The interconnection of porosity was also | ||
| examined on all coupons. The coating | ||
| technique utilized in this study is identical to the coating | ||
| technique used for specified medical | ||
| implants. | ||
| Static Shear and | ||
| Tensile Testing | TR-15-02 | |
| Abrasion Testing | TR-15-03 | |
| Shear fatigue | ||
| testing | TR-15-04 | The purpose of this study was to determine shear fatigue |
| strength of ASTM F75 CoCr coupons coated and sintered with | ||
| three layers of -40/+60 mesh CoCr powder. The coating | ||
| technique utilized in this study is identical to the coating | ||
| technique used for specified medical implants. |
Clinical Testing:
Clinical Testing was not required for these components to support substantial equivalence determination.