(90 days)
The INBONE Total Ankle System and INFINITY Total Ankle System are indicated for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis.
The INBONE Total Ankle System and INFINITY Total Ankle System are additionally indicated for patients with a failed previous ankle surgery.
CAUTION: In the United States, the ankle prosthesis is intended for cement use only.
The subject INBONE™ and INFINITY™ Total Ankle Systems are fixed-bearing, bone-sparing ankle replacement prostheses that restore mobility to a failing ankle joint. Both the INFINITY and INBONE systems include three components (tibial trays with or without stems, poly inserts, and talar domes) that are assembled together to create the two-piece prosthesis.
This is a 510(k) premarket notification for a medical device (INFINITY and INBONE Total Ankle Systems) and does not contain the detailed information typically found in a study proving a device meets specific acceptance criteria in the context of AI/ML or diagnostic performance. Instead, it demonstrates substantial equivalence to predicate devices, focusing on design, materials, and non-clinical performance.
Therefore, many of the requested points cannot be answered from the provided text. I will address the points that can be inferred or directly stated.
1. A table of acceptance criteria and the reported device performance
The document does not present acceptance criteria or reported device performance in the form of a table with numerical values for metrics like sensitivity, specificity, or image quality, as would be expected for a diagnostic or AI-driven device. Instead, it lists non-clinical tests performed to demonstrate substantial equivalence to predicate devices.
| Acceptance Criteria (Non-Clinical Tests) | Reported Device Performance (as demonstrated by testing) |
|---|---|
| Chemical Analysis | Demonstrated equivalence to predicate devices |
| Compressive Strength | Demonstrated equivalence to predicate devices |
| Shear and Tensile Strength | Demonstrated equivalence to predicate devices |
| MRI Safety Analysis | Minimal risk to patients in an MR environment (MR Conditional) |
| Direct Metal Laser Sintering (DMLS) Process Validation | Demonstrated equivalence to predicate devices (Performance Qualification, Mechanical validation, Microstructure, Powder Bed Position Validation) |
| Endotoxin (<20EU/device) | Demonstrated equivalence to predicate devices |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
Not applicable. This submission relies on non-clinical bench testing and comparison to predicate devices, not clinical or image-based test sets.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
Not applicable. No expert review for ground truth was conducted as no clinical efficacy/diagnostic study was performed.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. No clinical efficacy/diagnostic study was performed, thus no adjudication method was used.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. No MRMC study was done, as this is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical implant, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. The "ground truth" equivalent for this type of submission is the established performance and safety profile of the predicate devices based on their historical use and regulatory clearances, and the results of the non-clinical bench tests demonstrating similar physical and mechanical properties.
8. The sample size for the training set
Not applicable. There is no AI/ML component, so no training set was used.
9. How the ground truth for the training set was established
Not applicable. There is no AI/ML component, so no training set or associated ground truth establishment process was used.
{0}------------------------------------------------
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 square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 22, 2019
Wright Medical Technology, Inc. Rachel Roberts Regulatory Affairs Specialist II 1023 Cherry Road Memphis, Tennessee 38117
Re: K191393
Trade/Device Name: INFINITY Total Ankle System, INBONE 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: Mav 23, 2019 Received: May 24, 2019
Dear Rachel Roberts:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
{1}------------------------------------------------
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
CAPT Raquel Peat, PhD, MPH, USPHS For : Director OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K191393
Device Name
INFINITY Total Ankle System, INBONE Total Ankle System
Indications for Use (Describe)
The INBONE Total Ankle System and INFINITY Total Ankle System are indicated for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis.
The INBONE Total Ankle System and INFINITY Total Ankle System are 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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 Drug 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}------------------------------------------------
Image /page/3/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
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 INBONE™ and INFINITY™ Total Ankle Systems.
| (a)(1). Submitted By: | Wright Medical Technology, Inc.1023 Cherry RoadMemphis, TN 38117 |
|---|---|
| Date: | May 23, 2019 |
| Contact Person: | Rachel RobertsRegulatory Affairs Specialist IIOffice (901) 867-9708Fax (901) 867-4190 |
| (a)(2). Proprietary Name: | INBONE and INFINITY Total Ankle Systems |
| 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: | K172633 – INFINITY Total Ankle SystemK123059 – INBONE Total Ankle System |
(a)(4). Device Description
The subject INBONE™ and INFINITY™ Total Ankle Systems are fixed-bearing, bone-sparing ankle replacement prostheses that restore mobility to a failing ankle joint. Both the INFINITY and INBONE systems include three components (tibial trays with or without stems, poly inserts, and talar domes) that are assembled together to create the two-piece prosthesis.
(a)(5). Intended Use
INBONE™ and INFINITY™ Total Ankle Systems are intended to give a patient limited mobility by reducing pain, restoring alignment and replacing the flexion and extension movement in the ankle joint.
{4}------------------------------------------------
Indications for Use
The INBONE™ Total Ankle System and INFINITY™ Total Ankle System are indicated for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis. The INBONE™ Total Ankle System and INFINITY™ Total Ankle System are 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 INBONE and INFINITY Total Ankle Systems have 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 .
- . Compressive Strength
- Shear and Tensile Strength
- MRI Safety Analysis
- Direct Metal Laser Sintering (DMLS) Process Validation
- o
- o Performance Qualification- Mechanical validation and Microstructure
- Powder Bed Position Validation .
- Endotoxin (<20EU/device)
(b)(2). Substantial Equivalence- Clinical Evidence
Clinical Studies were not required to demonstrate equivalence between the subject and predicate devices
(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 devices. In addition, the subject device is expected to pose minimal risk to patients when place in an MR environment and is categorized as MR Conditional.
§ 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.