(237 days)
No
The summary does not mention AI, ML, or any related technologies. The device description focuses on the mechanical components and manufacturing process.
Yes
The device is described as a replacement prosthesis for damaged ankle joints due to severe arthritis or failed previous surgeries, aiming to restore mobility. This directly addresses medical conditions to improve health, which aligns with the definition of a therapeutic device.
No
The device is an ankle replacement prosthesis, which is a therapeutic device used to restore mobility to a failing ankle joint, not a diagnostic device that identifies or characterizes a disease or condition.
No
The device description clearly states it is a "fixed-bearing, bone-sparing ankle replacement prosthesis" with physical components (tibial tray, poly insert, talar dome) made using manufacturing technology. This indicates a physical medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a prosthesis for replacing a damaged ankle joint due to arthritis or failed surgery. This is a surgical implant, not a test performed on a sample taken from the body.
- Device Description: The description details the physical components of an ankle replacement prosthesis (tibial tray, poly insert, talar dome). This is consistent with a medical device used in surgery, not an IVD.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
The device is a surgical implant intended to restore function to a damaged ankle joint.
N/A
Intended Use / Indications for Use
The INFINITY Total Ankle System is indicated for patients with ankle joints damaged by severe rheumatoid, posttraumatic, or degenerative arthritis.
The INFINITY Total Ankle System is additionally indicated for patients with a failed previous ankle surgery.
CAUTION: In the United States, the ankle prosthesis is intended for cement use only.
Product codes
HSN
Device Description
The subject INFINITY™ Total Ankle System is a fixed-bearing, bone-sparing ankle replacement prosthesis that restores mobility to a failing ankle joint. The system includes three components (i.e., tibial tray, poly insert, and talar dome) that are assembled together to create the two-piece prosthesis. The talar dome is manufactured using additive manufacturing technology.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ankle joint
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
Non-clinical performance bench testing was performed to demonstrate substantial equivalence to the predicate devices.
- Chemical Analysis
- Abrasion Resistance
- Stereological Evaluation
- Compressive Strength
- Shear and Tensile Strength
- Fatigue Testing
- MRI Safety Analysis
- Direct Metal Laser Sintering (DMLS) Process Validation
- Operational Qualification-Mechanical validation and Microstructure o
- Performance Qualification- Mechanical validation and Microstructure o
- . Powder Bed Position Validation
- . Powder Recycling Validation
Clinical Studies were not required to demonstrate substantial equivalence between the subject device and the predicate devices.
Key Metrics
Not Found
Predicate Device(s)
K123954, K140749, K141740, K161742
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3110 Ankle joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. An ankle joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace an ankle joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces and has no linkage across-the-joint. This generic type of device includes prostheses that have a talar resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a tibial resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Wright Medical Technology, Inc. Tara Conrad Regulatory Affairs Specialist II 1023 Cherry Road Memphis, Tennessee 38117
April 26, 2018
Re: K172633
Trade/Device Name: INFINITY Total Ankle System Regulation Number: 21 CFR 888.3110 Regulation Name: Ankle joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: HSN Dated: March 26, 2018 Received: March 27, 2018
Dear Ms. Conrad:
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 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.
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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.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Katherine D. Kavlock -S
for 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)
K172633
Device Name
INFINITY Total Ankle System
Indications for Use (Describe)
The INFINITY Total Ankle System is indicated for patients with ankle joints damaged by severe theumatoid, posttraumatic, or degenerative arthritis.
The INFINITY Total Ankle System is additionally indicated for patients with a failed previous ankle surgery.
CAUTION: In the United States, the ankle prosthesis is intended for cement use only.
Type of Use (Select one or both, as applicable)
X 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)
3
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Image /page/4/Picture/1 description: The image shows the Wright logo. The logo consists of two overlapping trapezoids, one red and one orange, followed by the word "WRIGHT" in red, and the words "FOCUSED EXCELLENCE" in gray below. The logo is simple and modern, and the colors are bright and eye-catching.
1023 Cherry Road Memphis, TN 38117 wright.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 807.92, this information serves as a Summary of Safety and Effectiveness for the use of the INFINITY™ Total Ankle System.
| (a)(1). Submitted By: | Wright Medical Technology, Inc.
1023 Cherry Road
Memphis, TN 38117 |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | April 25, 2018 |
| Contact Person: | Tara Conrad
Regulatory Affairs Specialist II
Office (901) 867-4367
Fax (901) 867-4190 |
| (a)(2). Proprietary Name: | INFINITY Total Ankle System |
| Common Name: | Total Ankle Prosthesis |
| Classification Name and Reference: | 21 CFR 888.3110 - Class II |
| Device Product Code, Device Panel: | HSN - Orthopedic |
| (a)(3). Predicate Device: | K123954, K140749 –INFINITY Total Ankle
System
K141740 - INBONE and INFINITY Total Ankle
Systems
K161742- Aequalis PerFORM Reversed,
Aequalis PerFORM+ Reversed Glenoid |
(a)(4). Device Description
The subject INFINITY™ Total Ankle System is a fixed-bearing, bone-sparing ankle replacement prosthesis that restores mobility to a failing ankle joint. The system includes three components (i.e., tibial tray, poly insert, and talar dome) that are assembled together to create the two-piece prosthesis. The talar dome is manufactured using additive manufacturing technology.
(a)(5). Intended Use
INFINITY Total Ankle System is intended to give a patient limited mobility by reducing pain, restoring alignment and replacing the flexion and extension movement in the ankle joint.
5
Indications for Use
INFINITY Total Ankle System is indicated for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis. INFINITY Total Ankle System is additionally indicated for patients with a failed previous ankle surgery.
CAUTION: In the United States, the ankle prosthesis is intended for cement use only.
(a)(6). Technological Characteristics Comparison
The INFINITY Total Ankle System has identical indications, utilizes similar instrumentation, is made from identical materials, and has identical sterilization methods when compared to the legally marketed predicate devices.
(b)(1). Substantial Equivalence- Non-Clinical Evidence
Non-clinical performance bench testing was performed to demonstrate substantial equivalence to the predicate devices.
- Chemical Analysis
- Abrasion Resistance
- Stereological Evaluation
- Compressive Strength
- Shear and Tensile Strength
- Fatigue Testing
- MRI Safety Analysis
- Direct Metal Laser Sintering (DMLS) Process Validation
- Operational Qualification-Mechanical validation and Microstructure o
- Performance Qualification- Mechanical validation and Microstructure o
- . Powder Bed Position Validation
- . Powder Recycling Validation
- Endotoxin (