(58 days)
No
The document describes a mechanical implant (tibial base) and its physical properties, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is an orthopedic implant (tibial base) used in knee arthroplasty to treat conditions like osteoarthritis and rheumatoid arthritis, which are therapeutic interventions.
No
The device is a knee arthroplasty implant (tibial base) used for treatment, not for diagnosing a condition.
No
The device description clearly indicates it is a physical implantable device made of titanium alloy with a porous coating and spikes, intended for surgical implantation in the knee. It is a hardware device, not software.
Based on the provided information, the ADVANCE® Porous Coated Spiked Tibial Base 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 and Intended Use: The description clearly states that the device is a tibial component used in knee arthroplasty. This is a surgical procedure involving the replacement of a joint. The device is implanted directly into the patient's body.
- Lack of Mention of Samples or Testing: There is no mention of the device being used to analyze samples or perform any kind of diagnostic test.
Therefore, the ADVANCE® Porous Coated Spiked Tibial Base is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The ADVANCE® Porous Coated Spiked Tibial Base 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® Porous Coated Spiked Tibial Base is for uncemented use only.
Product codes (comma separated list FDA assigned to the subject device)
MBH
Device Description
The subject device is a line extension of the ADVANCE® Total Knee System.
The ADVANCE® Porous Coated Spiked Tibial Base is a porous coated tibial component with spikes on the distal surface for additional fixation. The design features are summarized below:
- Manufactured from titanium alloy ●
- Titanium sintered bead porous coating .
- Offered in the same size ranges as the predicate device ●
- Compatible with all 510(k) cleared ADVANCE® II Tibial Inserts and . EVOLUTION® Adaptive Inserts
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 primary predicate device was subject to rotational stability testing and fatigue evaluation per ASTM F1800. Additionally, the porous coating has been characterized for the reference device. Due to identical structural geometries and porous coatings, this testing and characterization remains applicable for the subject device, and it is expected to perform as well or better than the predicate devices.
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.
ADVANCE® HA Coated Spiked Tibial Base and HA Coated Modular Keel (K043083)
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.
ADVANCE® II Porous Coated Modular Titanium Tibial Component (K061223), EVOLUTION® CS/CR Porous Coated Femur (K140735)
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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of a stylized human figure with three faces in profile, representing the department's focus on health and human well-being. The logo is simple, using only black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 21, 2015
MicroPort Orthopedics, Inc. Ms. Caroline Fryar Regulatory Affairs Specialist 5677 Airline Road Arlington, Tennessee 38002
Re: K143366
Trade/Device Name: ADVANCE® Porous Coated Spiked Tibial Base Regulation Number: 21 CFR 888.3565 Regulation Name: Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis Class: Class II Product Code: MBH Dated: December 19, 2014 Received: December 22, 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 (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
1
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 yours,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K143366
Device Name
ADVANCE® Porous Coated Spiked Tibial Base
Indications for Use (Describe)
The ADVANCE® Porous Coated Spiked Tibial Base 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® Porous Coated Spiked Tibial Base is for uncemented use only.
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)
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ADVANCE® Porous Coated Spiked Tibial Base Special 510(k) Tab 007: 510(k) Summary of Safety and Effectiveness
Image /page/3/Picture/2 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 ADVANCE® Porous Coated Spiked Tibial Base.
| Submitted by: | MicroPort Orthopedics Inc.
5677 Airline Rd, Arlington TN, 38002
Phone: 866-872-0211
Fax: 855-446-2247 |
|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------|
| Date: | November 14, 2014 |
| Contact Person: | Caroline Fryar
Regulatory Affairs Specialist |
| Proprietary Name: | ADVANCE® Spiked Tibial Base |
| Common Name: | Tibial Base |
| Classification Name and Reference: | 21 CFR888.3565 Knee joint Patellofemorotibial metal/Polymer
Porous-Coated Uncemented prosthesis
Class II |
| Subject Product Code and Panel Code: | Orthopedics/87/MBH |
| Primary Predicate Device: | ADVANCE® HA Coated Spiked Tibial Base and HA Coated
Modular Keel
(K043083) |
| Reference Device: | ADVANCE® II Porous Coated Modular Titanium Tibial Component
(K061223)
EVOLUTION® CS/CR Porous Coated Femur (K140735) |
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DEVICE INFORMATION
A. Intended Use
The ADVANCE® Porous Coated Spiked Tibial Base 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
-
- Revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques.
The ADVANCE® Porous Coated Spiked Tibial Base is for uncemented use only.
B. Device Description
The subject device is a line extension of the ADVANCE® Total Knee System.
The ADVANCE® Porous Coated Spiked Tibial Base is a porous coated tibial component with spikes on the distal surface for additional fixation. The design features are summarized below:
- Manufactured from titanium alloy ●
- Titanium sintered bead porous coating .
- Offered in the same size ranges as the predicate device ●
- Compatible with all 510(k) cleared ADVANCE® II Tibial Inserts and . EVOLUTION® Adaptive Inserts
C. Substantial Equivalence Information
The design features and materials of the subject device are substantially equivalent to those of the predicate and reference devices. The indications for use are identical to the predicate device and the fundamental scientific technology of the modified device has not changed relative to the predicate device. The safety and effectiveness of the subject device is adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification.
D. Nonclinical Testing
The primary predicate device was subject to rotational stability testing and fatigue evaluation per ASTM F1800. Additionally, the porous coating has been characterized for the reference device. Due to identical structural geometries and porous coatings, this
5
ADVANCE® Porous Coated Spiked Tibial Base
Special 510(k)
Tab 007: 510(k) Summary of Safety and Effectiveness
testing and characterization remains applicable for the subject device, and it is expected to perform as well or better than the predicate devices.
E. Clinical Testing
Clinical data was not provided for the subject devices.
F. Conclusion
The design features, materials information, predicate testing and analysis data provided in this premarket notification adequately support the substantial equivalence of the ADVANCE® Porous Coated Spiked Tibial Base.