(31 days)
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.
The INFINITY® Total Ankle System is a fixed-bearing, bone-sparing total ankle prosthesis that restores mobility to a failing ankle joint. It encompasses three components (i.e., tibial tray, tibial insert, and talar dome) that are assembled together 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.
This document describes a 510(k) premarket notification for the WMT INFINITY® Total Ankle System. The document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a study proving performance against acceptance criteria for a novel device. Therefore, much of the requested information regarding acceptance criteria, performance studies, sample sizes, expert ground truth, and comparative effectiveness studies is not applicable or not provided in the given text.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not explicitly defined in terms of measurable performance metrics. The core "acceptance criterion" for this 510(k) submission is demonstrating substantial equivalence to a predicate device.
- Reported Device Performance: The document states that "Through mechanical analysis the subject devices do not represent a new worst-case. Therefore, no additional mechanical testing was performed to support the subject devices." This implies that the performance is considered to be equivalent to the predicate device, which is presumably already proven safe and effective.
| Acceptance Criteria Category | Specific Criteria (Implicit for Substantial Equivalence) | Reported Device Performance |
|---|---|---|
| Mechanical Performance | No new worst-case mechanical behavior compared to predicate. | No new worst-case identified through mechanical analysis. |
| Material Composition | Same materials as predicate. | Composed of Titanium Alloy, Cobalt Chrome, Ultra High Molecular Weight Polyethylene, and commercially pure Titanium (same as predicate). |
| Design Features | Clinically relevant design features maintained; differences do not raise new safety/effectiveness questions. | Maintains clinically relevant design features. Differences are an anterior-posterior (AP) tray length and neutral posterior curvature, which do not raise new safety/effectiveness questions. |
| Intended Use/Indications | Intended use and indications are substantially equivalent to predicate. | Intended use and indications are equivalent to the predicate. |
2. Sample Size for Test Set and Data Provenance: Not applicable. This submission relies on a comparison to a predicate device and mechanical analysis, not a clinical trial with a test set of data.
3. Number of Experts and Qualifications for Ground Truth for Test Set: Not applicable. Ground truth as typically defined for algorithm performance in AI/ML is not established here. The "ground truth" is the established safety and effectiveness of the predicate device.
4. Adjudication Method for Test Set: Not applicable. No test set requiring expert adjudication is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. This is not a study comparing human readers with and without AI assistance.
6. Standalone (Algorithm Only) Performance Study: Not applicable. This device is a physical medical implant, not an algorithm.
7. Type of Ground Truth Used: The "ground truth" in this context is the established safety and effectiveness of the legally marketed predicate device (K123954 INFINITY® Total Ankle System).
8. Sample Size for Training Set: Not applicable. This document describes a medical device, not an AI/ML algorithm that requires a training set. The "training" in a regulatory sense would refer to the historical data and experience with the predicate device.
9. How Ground Truth for Training Set was Established: Not applicable. As above, this is a medical device, not an AI/ML algorithm. The safety and effectiveness of the predicate device would have been established through its own regulatory pathway, which may have included clinical data, mechanical testing, and biocompatibility assessments.
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APR 2 5 2014
Image /page/0/Picture/2 description: The image shows the logo for Wright, a company that focuses on excellence. The logo consists of a stylized "W" symbol on the left, followed by the word "WRIGHT" in bold, sans-serif font. Below the word "WRIGHT" is the tagline "FOCUSED EXCELLENCE" in a smaller, sans-serif font. The logo is simple, clean, and professional, conveying a sense of focus and quality.
Wright Medical Technology, Inc. 1023 Cherry Road Memphis, TN 38117 www.wmt.com
510(K) SUMMARY
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 WMT INFINITY® Total Ankle System.
(a)(1). Submitted By:
Date:
Contact Person:
March 24, 2014
1023 Cherry Road Memphis, TN 38117
Jeanine Redden Director, Regulatory Affairs Phone: 901.867.4522 Fax: 901.687.4190
Wright Medical Technology, Inc.
(a)(2). Proprietary Name:
Common Name:
Classification Name and Reference:
Device Product Code, Device Panel:
(a)(3). Predicate Device:
INFINITY™ Total Ankle System
Ankle Prosthesis
21 CFR 888.3110 -- Class II
HSN: Ankle Prosthesis
K123954 INFINITY® Total Ankle System
(a)(4). Device Description
The INFINITY® Total Ankle System is a fixed-bearing, bone-sparing total ankle prosthesis that restores mobility to a failing ankle joint. It encompasses three components (i.e., tibial tray, tibial insert, and talar dome) that are assembled together 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.
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(a)(5). 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.
(a)(6). Technological Characteristics Comparison
The INFINITY® Total Ankle System is technologically substantially equivalent to the predicates. A summary of the changes is below.
The INFINITY Tibial Tray Line addition maintains, without modification for each corresponding size, all the clinically relevant design features of the INFINITY Total Ankle Tibial Tray, The differences between the subject, INFINITY Tibial Tray line extension, and the predicate, INFINITY Tibial Tray, is the addition of a shorter anterior-posterior (AP) tray length and a neutral posterior curvature posterior. The line addition includes short sizes of sizes 3-6.
The tibial tray line addition uses the identical INFINITY tibial bone interface geometry, three angled proximal peg configuration, peg diameter, and lock detail fits between the tibial insert and tib tray size. Additionally, the subject's anterior profile, medial-lateral (M-L) outer profile, component thickness, and tibial insert assembly features are also identical to the predicate design.
(b)(1). Substantial Equivalence - Non-Clinical Evidence
Through mechanical analysis the subject devices do not represent a new worst-case. Therefore, no additional mechanical testing was performed to support the subject devices.
(b)(2). Substantial Equivalence - Clinical Evidence
N/A
(b)(3). 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 system.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a symbol often associated with medicine and healthcare.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 25, 2014
Wright Medical Technology, Incorporated Ms. Jeanine Redden Director, Regulatory Affairs 1023 Cherry Road Memphis. Tennessee 38117
Re: K140749
Trade/Device Name: INFINITYTM 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, 2014 Received: March 28, 2014
Dear Ms. Redden:
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
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Page 2 - Ms. Jeanine Redden
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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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/ReportalProblem/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.
Sincercly yours,
Ronald P.: Jean -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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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K140749
Device Name
INFINITY™ Total Ankle System
Indications for Use (Describe)
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 cemented 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)
Ronald P. Jean -S 2014.04.25 10:03:35 -04'00'
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*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:
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§ 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.