(158 days)
Not Found
No
The summary describes a mechanical knee implant and its materials, design features, and performance testing, with no mention of AI or ML.
Yes
The device is a knee joint replacement implant intended to treat degenerative joint diseases and correct deformities, which are therapeutic interventions.
No
The device described is a knee joint replacement implant for surgical treatment, not for diagnosing conditions.
No
The device description clearly states it is a distal femoral knee joint replacement implant, which is a physical hardware component.
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 in patients with specific conditions. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details a physical implant made of Cobalt Chrome Alloy, designed for surgical implantation. It does not involve any reagents, tests, or analysis of biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. This device is a prosthetic implant used in the body for treatment.
N/A
Intended Use / Indications for Use
The EVOLUTION® MP CS/CR Porous Femur is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions:
- Non-inflammatory degenerative joint disease: including osteoarthritis, traumatic 1. arthritis, or avascular necrosis
-
- Inflammatory degenerative joint disease, including rheumatoid arthritis;
- Correction of functional deformity 3.
-
- Revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques.
The EVOLUTION® MP CS/CR Porous Femur is for uncemented use only.
Product codes (comma separated list FDA assigned to the subject device)
MBH, JWH
Device Description
The EVOLUTION® MP CS/CR Porous Femur is a line extension of the EVOLUTION® MP Total Knee System product line. The device is a distal femoral knee joint replacement implant, and is porous coated for cementless fixation. The design features are summarized below:
- . Manufactured from Cobalt Chrome Alloy
- . Inner surfaces coated with porous beads for cementless fixation
- Available in sizes 1-8, left and right ●
- Compatible with 510(k) cleared EVOLUTION® Tibial Inserts and ADVANCE® . Patellae
The tibial compatibility for the EVOLUTION® Adaptive CS and PS Tibial Inserts is being expanded to include all 510(k) cleared ADVANCE® II Tibial Bases. The subject designs and indications remain identical according to their respective 510(k) clearances.
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)
Nonclinical Testing:
The subject EVOLUTION® MP CS/CR Porous Femur was evaluated for comparison to the predicate femur cleared in K093552, and was found not to create a worst-case with respect to intrinsic femoral component strength. The testing concluded that the subject femoral component performs as well or better than the predicate device, and can be expected to perform well under normal physiological loading conditions.
Clinical Testing:
Clinical data was not provided for the subject devices.
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.
EVOLUTION® MP CS/CR Non-Porous Femur (K093552, K102380), ADVANCE® Porous Femur (K061223), EVOLUTION® Adaptive CS Insert (K113325), EVOLUTION® Adaptive PS Insert (K131679), ADVANCE® Spiked Porous Tibial Base (K063128)
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
§ 888.3565 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.
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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 circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or a caduceus, possibly representing health and well-being. The logo is presented in black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 29, 2014
Microport Orthopedics, Incorporated Ms. Caroline Fryar Regulatory Affairs Specialist 5677 Airline Road Arlington, Tennessee 38002
Re: K140735
Trade/Device Name: EVOLUTION® MP CS/CR Porous Femur Regulation Number: 21 CFR 888.3565 Regulation Name: Knee Joint Patellofemorotibial Metal/Polymer Porous-Coated Uncemented Prosthesis Regulatory Class: Class II Product Code: MBH, JWH Dated: August 5, 2014 Received: August 6, 2014
Dear Ms. Fryar:
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
1
(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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.
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/Resourcesfor You/Industry/default.htm. 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/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,
Image /page/1/Picture/8 description: The image shows the name "Lori A. Wiggins -S" in a simple, sans-serif font. The text is black against a white background, making it easily readable. The name appears to be a signature or a label, possibly indicating the author or owner of a document or piece of work. The "-S" at the end might represent an initial or a designation.
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
K140735
Device Name EVOLUTION® MP CS/CR Porous Femur
Indications for Use (Describe)
The EVOLUTION® MP CS/CR Porous Femur is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions:
- Non-inflammatory degenerative joint disease: including osteoarthritis, traumatic arthritis, or avascular necrosis
-
- Inflammatory degenerative joint disease, including rheumatoid arthritis;
-
- Correction of functional deformity
- Revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques.
The EVOLUTION® MP CS/CR Porous Femur is for uncemented use only.
Type of Use (Select one or both, as applicable)
Z Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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EVOLUTION® MP CS/CR Porous Femur Traditional 510(k) Tab 005: 510(k) Summary of Safety and Effectiveness
Image /page/3/Picture/1 description: The image shows the logo and contact information for MicroPort Orthopedics. The logo features the company name in blue and red text, with a red star-like symbol to the left. Below the logo is the company name again, followed by the address 5677 Airline Road, Arlington, TN 38002, and the website ortho.microport.com.
510(k) Summary of Safety and Effectiveness
In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807, this information serves as a Summary of Safety and Effectiveness for the use of the EVOLUTION® MP CS/CR Porous Femur and EVOLUTION® Adaptive CS Inserts.
| Submitted by: | MicroPort Orthopedics Inc. |
|---|---|
| 5677 Airline Rd, Arlington TN, 38002 | |
| Phone: 866-872-0211 | |
| Fax: 855-446-2247 | |
| Date: | August 27, 2014 |
| Contact Person: | Caroline Fryar |
| Regulatory Affairs Specialist | |
| Proprietary Name: | EVOLUTION® MP CS/CR Porous Femur |
| EVOLUTION® Adaptive CS and PS Inserts | |
| Common Name: | Cementless Femoral Component |
| Tibial Insert | |
| Classification Name and Reference: | 21 CFR888.3565 Knee joint Patellofemorotibial metal/Polymer |
| Porous-Coated Uncemented prosthesis | |
| 21 CFR 888.3560 Knee joint patellofemorotibial | |
| polymer/metal/polymer semi-constrained cemented prosthesis | |
| Class II | |
| Subject Product Code and Panel Code: | Orthopedics/87/MBH |
| Orthopedics/87/MBH, JWH | |
| Predicate Devices: | EVOLUTION® MP CS/CR Non-Porous Femur (K093552, K102380) |
| ADVANCE® Porous Femur (K061223) | |
| EVOLUTION® Adaptive CS Insert (K113325) | |
| EVOLUTION® Adaptive PS Insert (K131679) | |
| ADVANCE® Spiked Porous Tibial Base (K063128) |
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DEVICE INFORMATION
A. Intended Use
The EVOLUTION® MP CS/CR Porous Femur is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions:
- Non-inflammatory degenerative joint disease: including osteoarthritis, traumatic 1. arthritis, or avascular necrosis
-
- Inflammatory degenerative joint disease, including rheumatoid arthritis;
- Correction of functional deformity 3.
-
- Revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques.
The EVOLUTION® MP CS/CR Porous Femur is for uncemented use only.
B. Device Description
The EVOLUTION® MP CS/CR Porous Femur is a line extension of the EVOLUTION® MP Total Knee System product line. The device is a distal femoral knee joint replacement implant, and is porous coated for cementless fixation. The design features are summarized below:
- . Manufactured from Cobalt Chrome Alloy
- . Inner surfaces coated with porous beads for cementless fixation
- Available in sizes 1-8, left and right ●
- Compatible with 510(k) cleared EVOLUTION® Tibial Inserts and ADVANCE® . Patellae
The tibial compatibility for the EVOLUTION® Adaptive CS and PS Tibial Inserts is being expanded to include all 510(k) cleared ADVANCE® II Tibial Bases. The subject designs and indications remain identical according to their respective 510(k) clearances.
C. Substantial Equivalence Information
The design features and materials of the subject devices are substantially equivalent to those of the predicate devices. The indications for use are identical to the predicate devices. The fundamental scientific technology of the modified devices has not changed relative to the predicate devices, as well. The safety and effectiveness of the subject devices are adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification.
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D. Nonclinical Testing
The subject EVOLUTION® MP CS/CR Porous Femur was evaluated for comparison to the predicate femur cleared in K093552, and was found not to create a worst-case with respect to intrinsic femoral component strength. The testing concluded that the subject femoral component performs as well or better than the predicate device, and can be expected to perform well under normal physiological loading conditions.
E. Clinical Testing
Clinical data was not provided for the subject devices.
F. Conclusion
The design features of the subject devices are substantially equivalent to the predicate devices. The instruments and materials remain identical to those cleared under K093552, K102380, K113325, and K131679. The safety and effectiveness of the subject devices is adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification.