(95 days)
No
The document describes a mechanical implant (tibial system) and does not mention any software, algorithms, or data processing that would involve AI or ML.
Yes
The device is indicated for use in knee arthroplasty to treat various degenerative joint diseases and deformities, which constitutes a therapeutic intervention.
No
This device is a knee arthroplasty system intended for use in surgical procedures to replace knee joints, not to diagnose medical conditions.
No
The device description explicitly states it is manufactured from titanium alloy and describes physical components like tibial bases, keels, and stems, indicating it is a hardware 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 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 the EVOLUTION® BIOFOAM® and ADVANCE® BIOFOAM® Tibial Systems are implants used in knee arthroplasty (joint replacement surgery). They are physical devices intended to be surgically implanted into the patient's body.
- Lack of Diagnostic Activity: The intended use and device description do not mention any testing of biological samples or diagnostic procedures. The device's purpose is to replace a damaged joint, not to diagnose a condition.
Therefore, this device falls under the category of a surgical implant or prosthetic device, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The EVOLUTION® BIOFOAM® Tibial System 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® BIOFOAM® Tibial System is for use without bone cement.
The ADVANCE® BIOFOAM® Tibial System 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 ADVANCE® BIOFOAM® Tibial System is for use without bone cement and is intended for use with EVOLUTION® and ADVANCE® modular keels.
Product codes
MBH
Device Description
The EVOLUTION® BIOFOAM® Tibial System is a line extension of the EVOLUTION® MP Total Knee System product line. The device is an asymmetrical tibial base with a BIOFOAM® coating on the distal surface. The design features are summarized below:
- Manufactured from titanium alloy conforming to ASTM F620/F136 (forged/wrought)
- Available in 11 sizes, left and right
- Tibial base is available with and without holes for bone screws
- System includes 3 options of modular keels consisting of a two fin bullet-tip, a four fin bullet-tip and a four fin stem-accepting keel
- Compatible with 510(k) cleared EVOLUTION® Tibial Inserts, ADVANCE® Keels and ADVANTIM® Stems
The keel compatibility for the ADVANCE® BIOFOAM® Tibia is being expanded to include all keels subject to this 510(k). The subject design and indications remain identical according to K063128.
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
Prescription Use
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
Nonclinical Testing:
The subject EVOLUTION® BIOFOAM® Tibial System was evaluated for fatigue strength per ASTM F1800 and 3-point stem fatigue. Results concluded that the subject tibial base is expected to perform as well or better than the predicate device in fatigue loading.
Clinical Testing:
Clinical data was not provided for the subject devices.
Key Metrics
Not Found
Predicate Device(s)
ADVANCE® Porous Coated Spiked Tibial Base (K143366)
Reference Device(s)
ADVANCE® HA Coated Components (K043083), ADVANCE® Spiked Porous Tibial Base (K063128), EVOLUTION® MP Tibial Base (K093552, K102380), EVOLUTION® MP CS/CR Porous Femur (K140735)
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 16, 2015
MicroPort Orthopedics, Incorporated Mr. Byron Ledbetter Regulatory Affairs Specialist II 5677 Airline Road Arlington, Tennessee 38002
Re: K152298
Trade/Device Name: EVOLUTION® BIOFOAM® Tibial System, ADVANCE® BIOFOAM® Tibial System 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: August 11, 2015 Received: August 26, 2015
Dear Mr. Ledbetter:
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
Page 2 - Mr. Byron Ledbetter
(21 CFR Part 807); labeling (21 CFR Parts 801); medical device reporting of medical device-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/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 vours.
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
510(k) Number (if known) K152298
Device Name
EVOLUTION® BIOFOAM® Tibial System
Indications for Use (Describe)
The EVOLUTION® BIOFOAM® Tibial System 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® BIOFOAM® Tibial System is for use without bone cement.
Type of Use (Select one or both, as applicable)
2 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)
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 Druq 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
Indications for Use
510(k) Number (if known) K152298
Device Name ADVANCE® BIOFOAM® Tibial System
Indications for Use (Describe)
The ADVANCE® BIOFOAM® Tibial System 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 ADVANCE® BIOFOAM® Tibial System is for use without bone cement and is intended for use with EVOLUTION® and ADVANCE® modular keels.
Type of Use (Select one or both, as applicable)
2 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)
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 Druq 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."
4
EVOLUTION® BIOFOAM® Tibial System Traditional 510(k) Tab 006: 510(k) Summary of Safety and Effectiveness
Image /page/4/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, along with a blue square containing a red star-like shape. Below the logo is the company's address, which is 5677 Airline Road, Arlington, TN 38002, and their 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® BIOFOAM® Tibial System.
| Submitted by: | MicroPort Orthopedics Inc. |
|---|---|
| 5677 Airline Rd, Arlington TN, 38002 | |
| Phone: 866-872-0211 | |
| Fax: 855-446-2247 | |
| Date: | November 16, 2015 |
| Contact Person: | Byron Ledbetter |
| Regulatory Affairs Specialist II | |
| Proprietary Name: | EVOLUTION® BIOFOAM® Tibial System |
| ADVANCE® BIOFOAM® Tibia | |
| Common Name: | Cementless Tibial Base |
| Classification Name and Reference: | 21 CFR 888.3565 - Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis. |
| Subject Product Code and Panel Code: | Class II |
| Orthopedics/87/MBH | |
| Predicate Device: | ADVANCE® Porous Coated Spiked Tibial Base (K143366) |
| Reference Devices: | ADVANCE® HA Coated Components (K043083) |
| ADVANCE® Spiked Porous Tibial Base (K063128) | |
| EVOLUTION® MP Tibial Base (K093552, K102380) | |
| EVOLUTION® MP CS/CR Porous Femur (K140735) |
5
DEVICE INFORMATION
A. Intended Use
EVOLUTION® BIOFOAM® Tibial System
The EVOLUTION® BIOFOAM® Tibial System 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® BIOFOAM® Tibial System is for use without bone cement.
ADVANCE® BIOFOAM® Tibial System
The ADVANCE® BIOFOAM® Tibial System 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 ADVANCE® BIOFOAM® Tibial System is for use without bone cement and is intended for use with EVOLUTION® and ADVANCE® modular keels.
B. Device Description
The EVOLUTION® BIOFOAM® Tibial System is a line extension of the EVOLUTION® MP Total Knee System product line. The device is an asymmetrical tibial base with a BIOFOAM® coating on the distal surface. The design features are summarized below:
6
EVOLUTION® BIOFOAM® Tibial System
Traditional 510(k)
Tab 006: 510(k) Summary of Safety and Effectiveness
- . Manufactured from titanium alloy conforming to ASTM F620/F136 (forged/wrought)
- . Available in 11 sizes, left and right
- Tibial base is available with and without holes for bone screws ●
- . System includes 3 options of modular keels consisting of a two fin bullet-tip, a four fin bullet-tip and a four fin stem-accepting keel
- Compatible with 510(k) cleared EVOLUTION® Tibial Inserts, ADVANCE® . Keels and ADVANTIM® Stems
The keel compatibility for the ADVANCE® BIOFOAM® Tibia is being expanded to include all keels subject to this 510(k). The subject design and indications remain identical according to K063128.
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 device, 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.
D. Nonclinical Testing
The subject EVOLUTION® BIOFOAM® Tibial System was evaluated for fatigue strength per ASTM F1800 and 3-point stem fatigue. Results concluded that the subject tibial base is expected to perform as well or better than the predicate device in fatigue loading.
E. Clinical Testing
Clinical data was not provided for the subject devices.
F. Conclusion
The design features, materials information, predicate testing and analysis date provided in this premarket notification adequately support the substantial equivalence of the EVOLUTION® BIOFOAM® Tibial System.