(217 days)
The INBONE™ Total Ankle System, the INFINITY™ Total Ankle System and the INVISION™ Total Ankle Revision System are indicated for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis.
The INBONE™ Total Ankle System, the INFINITY™ Total Ankle System and the INVISION™ Total Ankle Revision 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™ Total Ankle System, INFINITY™ Total Ankle System and INVISION™ Total Ankle Revision System are fixed-bearing, bone-sparing ankle replacement prostheses that restore mobility to a failing ankle joint. The systems include three components (i.e., tibial tray, poly insert, and talar dome) that are assembled together to create the two-piece prosthesis.
This is a 510(k) summary for a medical device (an ankle replacement system), not an AI/ML device. Therefore, the requested information about acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, and MRMC studies is largely not applicable in the context of AI/ML performance evaluation.
However, I can extract the information that is present regarding the non-clinical performance and a general conclusion of equivalency:
Device Name: The INBONE™ Total Ankle System, the INFINITY™ Total Ankle System and the INVISION™ Total Ankle Revision System
1. A table of acceptance criteria and the reported device performance
The document lists "Applicable Standard" for various non-clinical performance bench tests. The specific acceptance criteria (e.g., minimum tensile strength value) are not explicitly stated within this summary, nor are the reported performance values. The study concludes that the device performs "at least as well as the predicate devices," implying it met the standards.
| Non-clinical performance bench testing | Applicable Standard | Reported Device Performance |
|---|---|---|
| Tensile Properties | ASTM F648 | Met (Implied) |
| Percent Crystallinity | ASTM F2625 | Met (Implied) |
| Impact Resistance | ASTM F648 | Met (Implied) |
| Cross-Link Density | ASTM F2214 | Met (Implied) |
| Oxidation Characterization | ASTM F2102 | Met (Implied) |
| Density Characterization | ASTM D1505 | Met (Implied) |
| Fatigue Crack Growth Rate | ASTM E647 | Met (Implied) |
| Free Radical Concentration | No ASTM or ISO standard governing free radical concentration evaluation or acceptance in this submission | Met (Implied) |
| Wear Performance | ISO/DIS 22622 | Met (Implied) |
| Lock Detail Testing | ASTM F2665 | Met (Implied) |
| Articular Shear Stability | ASTM F2665 | Met (Implied) |
| Endotoxin (<20EU/device) | ANSI/AAMI ST72:2011 | Met (Implied) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided. The study relies on non-clinical bench testing, not patient data.
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, as this is a non-clinical bench testing report for a physical device, not an AI/ML diagnostic system. The "ground truth" here is adherence to engineering standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
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
No, an MRMC study was not done. This is a 510(k) for a physical medical device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for this submission are the performance specifications outlined in established ASTM/ISO standards for material properties and device performance. The testing aims to demonstrate that the device meets these engineering standards.
8. The sample size for the training set
Not applicable. There is no AI/ML model that requires a training set in this submission.
9. How the ground truth for the training set was established
Not applicable.
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June 8, 2020
Image /page/0/Picture/1 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
Wright Medical Technology, Inc. Antonio Ayala Regulatory Affairs Specialist 1023 Cherry Road Memphis, Tennessee 38117
Re: K193067
Trade/Device Name: The INBONE™ Total Ankle System, the INFINITY™ Total Ankle System and the INVISION™ Total Ankle Revision 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: May 6, 2020 Received: May 8, 2020
Dear Antonio Ayala:
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
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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,
Ting Song, Ph.D., R.A.C. Acting Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K193067
Device Name
The INBONE™ Total Ankle System, the INFINITY™ Total Ankle System and the INVISION™ Total Ankle Revision System
Indications for Use (Describe)
The INBONE™ Total Ankle System, the INFINITY™ Total Ankle System and the INVISION™ Total Ankle Revision System are indicated for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis.
The INBONE™ Total Ankle System, the INFINITY™ Total Ankle System and the INVISION™ Total Ankle Revision 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)
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Image /page/3/Picture/1 description: The image is a logo for Wright. The logo has two overlapping shapes on the left, one red and one orange. To the right of the shapes is the word "WRIGHT" in red, and below that is the phrase "FOCUSED EXCELLENCE" in a smaller, gray font.
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 INBONE™ Total Ankle System, the INFINITY™ Total Ankle System and the INVISION™ Total Ankle Revision System.
| (a)(1). Submitted By: | Wright Medical Technology, Inc.1023 Cherry RoadMemphis, TN 38117 |
|---|---|
| Date: | June 8th, 2020 |
| Contact Person: | Antonio AyalaRegulatory Affairs SpecialistOffice (901) 290-5640Fax (901) 867-4190 |
| (a)(2). Proprietary Name: | The INBONE™ Total Ankle System, theINFINITY™ Total Ankle System and theINVISION™ Total Ankle Revision 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: | K140749 – INFINITY Total Ankle SystemK133585 – INBONE Total Ankle SystemK100886 – INBONE Total Ankle SystemK142117 – INVISION Total Ankle Revision SystemK180730 – INVISION Total Ankle Revision System |
(a)(4). Device Description
The subject INBONE™ Total Ankle System, INFINITY™ Total Ankle System and INVISION™ Total Ankle Revision System are fixed-bearing, bone-sparing ankle replacement prostheses that restore mobility to a failing ankle joint. The systems include three components (i.e., tibial tray, poly insert, and talar dome) that are assembled together to create the two-piece prosthesis.
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(a)(5). Intended Use
The INBONE™ Total Ankle System, the INFINITY™ Total Ankle System and the INVISION™ Total Ankle Revision System are 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 INBONE™ Total Ankle System, the INFINITY™ Total Ankle System and the INVISION™ Total Ankle Revision System are indicated for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis.
The INBONE™ Total Ankle System, the INFINITY™ Total Ankle System and the INVISION™ Total Ankle Revision 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™ Total Ankle System, INFINITY™ Total Ankle System and INVISION™ Total Ankle Revision System have identical indications, utilizes similar instrumentation, are made from identical materials, and have identical sterilization methods when compared to the legally marketed predicate devices.
(b)(1). Substantial Equivalence- Non-Clinical Evidence
| Non-clinical performance benchtesting | Applicable Standard |
|---|---|
| Tensile Properties | ASTM F648 |
| Percent Crystallinity | ASTM F2625 |
| Impact Resistance | ASTM F648 |
| Cross-Link Density | ASTM F2214 |
| Oxidation Characterization | ASTM F2102 |
| Density Characterization | ASTM D1505 |
| Fatigue Crack Growth Rate | ASTM E647 |
| Free Radical Concentration | There is no ASTM or ISO standard governing free radicalconcentration evaluation or acceptance in this submission |
| Wear Performance | ISO/DIS 22622 |
| Lock Detail Testing | ASTM F2665 |
| Articular Shear Stability | ASTM F2665 |
| Endotoxin (<20EU/device) | ANSI/AAMI ST72:2011 |
Non-clinical performance bench testing was performed to demonstrate substantial equivalence to the predicate devices
(b)(2). Substantial Equivalence- Clinical Evidence
Clinical Studies were not required to demonstrate equivalence between the subject and predicate devices
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(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.