(101 days)
No
The device description and performance studies focus on the mechanical properties and design of a physical implant, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is described as a total ankle prosthesis intended to reduce pain, restore alignment, and replace movement in the ankle joint for patients with damaged ankle joints, which aligns with the definition of a therapeutic device.
No
Explanation: The device is a total ankle prosthesis designed to restore mobility, not to diagnose a condition.
No
The device description clearly states it is a "fixed-bearing total ankle prosthesis" composed of physical components made of Titanium Alloy, Cobalt Chrome, Ultra High Molecular Weight Polyethylene, and commercially pure Titanium. This indicates a hardware 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 and Indications: The device is intended to replace the ankle joint and restore mobility in patients with damaged ankle joints. This is a surgical implant, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a physical prosthesis made of various materials designed to be implanted in the ankle. It does not involve reagents, calibrators, or other components typically associated with IVDs.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
- Performance Studies: The performance studies described are related to the mechanical properties and stability of the implant, not the accuracy or reliability of a diagnostic test.
In summary, the INFINITY™ Total Ankle System is a medical device used for surgical implantation to treat a physical condition, not an in vitro diagnostic device used to diagnose or monitor a patient's health through the analysis of biological samples.
N/A
Intended Use / Indications for Use
Intended Use: The 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.
Indications for Use: The INFINITY™ Total Ankle is indicated for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis.
The INFINITY ™ Total Ankle is additionally indicated for patients with a failed previous ankle surgery.
CAUTION: The ankle prosthesis is intended for cement use only.
Product codes
HSN
Device Description
The INFINITY™ Total Ankle System is a fixed-bearing total ankle prosthesis that restores mobility to a failing ankle joint. It encompasses three components (i.e., tibial insert, and talar dome) that are assembled to create a two-piece prosthesis. The device is composed of Titanium Alloy, Cobalt Chrome, Ultra High Molecular Weight Polyethylene, and commercially pure Titanium and each component is available in multiple sizes to accommodate variable patient anatomy.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The following non-clinical analysis was performed:
-
- Bone interface stability testing
-
- Component stability testing
-
- Fatigue testing
-
- Contact area / contact stress testing
The results of this analysis show that the subject INFINITY™ Total Ankle System can be expected to perform at least as well as the legally marketed predicates referenced above. The safety and effectiveness of the INFINITY™ Total Ankle System is adequately supported by the substantial equivalence information, materials information, and comparison of design characteristics provided within this 510k submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K051023, K053569, K100886, K103374
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.
0
Create Motion."
Image /page/0/Picture/1 description: The image shows the word "WRIGHT." in a bold, sans-serif font. Below the word is a stylized graphic that resembles a "W" or a pair of wings. The text and graphic are both in black, creating a strong contrast against the white background.
K123954 Page 1 of 2
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
APR 0 1 2013
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.
| 1. Submitted By: | Wright Medical Technology, Inc. |
|---|---|
| 5677 Airline Road | |
| Arlington, TN 38002 | |
| Date: | April 1, 2013 |
| Contact Person: | Samir Ibrahim, PhD, RAC |
| Regulatory Affairs Specialist II | |
| Phone: (901) 290-5909 | |
| Fax: (901) 867 4190 | |
| 2. Proprietary Name: | INFINITY™ Total Ankle System |
| Common Name: | Ankle Prosthesis |
| Classification Name and Reference: | 21 CFR 888.3110 - Class II |
| Device Product Code, Device Panel: | HSN: Orthopedic |
| 3. Predicate Devices: | K051023 – INBONE® Total Ankle System |
| K053569 - DePuy Agility™ Total Ankle Prosthesis | |
| K100886 - INBONE® II Total Ankle System | |
| K103374 - INBONE® Total Ankle System |
4. Device Description
The INFINITY™ Total Ankle System is a fixed-bearing total ankle prosthesis that restores mobility to a failing ankle joint. It encompasses three components (i.e., tibial insert, and talar dome) that are assembled to create a two-piece prosthesis. The device is composed of Titanium Alloy, Cobalt Chrome, Ultra High Molecular Weight Polyethylene, and commercially pure Titanium and each component is available in multiple sizes to accommodate variable patient anatomy.
5. Intended Use
Intended Use: The 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.
headquarters Arlington, TN 38002 901.867.9971 phone Wright Medical Technology, Inc. 5677 Airline Road
1
Create Motion."
Image /page/1/Picture/1 description: The image shows the word "WRIGHT." in a bold, sans-serif font. Below the word is a stylized design that appears to be a series of overlapping, angled lines, creating a visual element that complements the text. The overall impression is a logo or branding element, with a clean and modern aesthetic.
K123954 Page 2 of 2
Indications for Use: The INFINITY™ Total Ankle is indicated for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis.
The INFINITY™ Total Ankle is additionally indicated for patients with a failed previous ankle surgery.
CAUTION: The ankle prosthesis is intended for cement use only.
Technological Characteristics Comparison 6.
The general technological features of the INFINITY™ Total Ankle System are similar to the predicate devices with regard to design and materials. The INFINITY™ design was to limit the amount of bone resection and soft tissue dissection required for ankle arthroplasty; hence, the overall profile of the INFINITY™ Total Ankle was significantly reduced relative to the INBONE® Il predicate.
7. Substantial Equivalence - Non-Clinical Evidence
The following non-clinical analysis was performed:
-
- Bone interface stability testing
-
- Component stability testing
-
- Fatigue testing
-
- Contact area / contact stress testing
The results of this analysis show that the subject INFINITY™ Total Ankle System can be expected to perform at least as well as the legally marketed predicates referenced above. The safety and effectiveness of the INFINITY™ Total Ankle System is adequately supported by the substantial equivalence information, materials information, and comparison of design characteristics provided within this 510k submission.
8. Substantial Equivalence - Clinical Evidence
N/A
9. Substantial Equivalence - Conclusions
The design characteristics of the subject system do not raise any new types of questions of safety or effectiveness. From the evidence submitted in this 510(k), the subject devices can be expected to perform at least as well as the predicate systems.
2
Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in bold, uppercase letters. The text is centered horizontally and appears to be the heading of a document or webpage. The font is a sans-serif typeface, and the overall impression is one of official government communication.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Wright Medical Technology, Incorporated % Samir Ibrahim, Ph.D. Regulatory Affairs Specialist II 5677 Airline Road Arlington, Tennessee 38002
Letter dated: April 1. 2013
Re: K123954
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 18, 2013 Received: March 19, 2013
Dear Dr. Ibrahim:
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
3
Page 2 - Samir Ibrahim, Ph.D.
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.
Sincerely yours,
Mark Newelkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Traditional 510(k) INFINITY™ Total Ankle System
INDICATIONS FOR USE STATEMENT
510(k) Number: K123954
Device Name:
INFINITY™ Total Ankle System
Indications For Use:
The INFINITY™ Total Ankle is indicated for patients with ankle joints damaged by severe rheumatoid, posttraumatic, or degenerative arthritis.
The INFINITY ™ Total Ankle is additionally indicated for patients with a failed previous ankle surgery.
CAUTION: The ankle prosthesis is intended for cement use only.
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number
Prescription Use (Per21 CFR 801.109)
OR
Over-The Counter Use (Optional Format 1-2-96)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Casey L. Hanley Ph.D.
Division of Orthopaedic Devices