The Vantage Total Ankle System is indicated for patients with ankle joints damaged by severe rheumatoid, posttraumatic, or degenerative arthritis. It is also indicated for revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present.

The Vantage Total Ankle System is indicated for cemented use only.

Device Description

The Vantage® Total Ankle System is a fixed-bearing total ankle replacement device that is comprised of four components (Tibial Plate, Liner, Talar Component and Locking Component).

The predicate Vantage Fixed Bearing Liners are constructed of compression-molded UHMWPE. This submission proposes Vantage Fixed Bearing Liners made from UHMWPE containing vitamin E. This submission additionally proposes minor geometric change(s) to all Fixed Bearing Liners as well as additional Fixed Bearing Liner thickness options.

AI/ML Overview

The provided text is a 510(k) summary for a medical device, the Vantage® Total Ankle System, specifically an orthopedic implant for ankle replacement. It does not describe an AI/ML-driven medical device or a study involving human readers or ground truth for image analysis. Therefore, it is impossible to extract the information requested in the prompt, as those details relate to the validation of AI/ML systems, which is not the subject of this document.

The document focuses on demonstrating substantial equivalence of a new version of the ankle system (with vitamin E-containing UHMWPE liners and minor geometric changes) to a previously cleared predicate device. It relies on non-clinical testing and engineering analyses (material characterization, wear, range of motion, stability, disassembly, biocompatibility, bacterial endotoxins) to show that the changes do not adversely affect safety or effectiveness.

Thus, I cannot provide a table of acceptance criteria and reported device performance related to AI/ML, nor details about sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set information, as this document is not about an AI/ML medical device.

Summary

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September 11, 2023

Exactech Inc. Liz Howell Senior Regulatory Specialist 2320 NW 66th Court Gainesville, Florida 32653

Re: K232002

Trade/Device Name: Vantage® 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: July 5, 2023 Received: July 5, 2023

Dear Liz Howell:

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,

Lixin Liu -S

Lixin Liu, Ph.D. 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) K232002

Device Name Vantage® Total Ankle System

Indications for Use (Describe)

The Vantage Total Ankle System is indicated for cemented use only.

Type of Use (Select one or both, as applicable)
☒ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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Vantage® Total Ankle System 510(k) Summary

Applicant:	Exactech®, Inc.2320 NW 66th CourtGainesville FL, 32653Phone: (352) 377-1140Fax: (352) 378-2617
Applicant Contact:	Liz HowellSenior Regulatory SpecialistTelephone: (352) 377-1140Fax: (352) 378-2617
Date:	September 8, 2023
Device Trade Name:	Vantage® Total Ankle System
Common Name:	Total Ankle Prosthesis
Classification Name:	Ankle joint metal/polymer semi-constrained cementedprosthesis
Regulation Number:	888.3110

Legally Marketed Predicate Devices:

510(k)	Trade Name	Product Code
K152217	Exactech Vantage Total Ankle System	HSN

Reference Devices:

510(k)	Trade Name	Product Code
K223252	TRULIANT® E-PX Tibial Inserts; TRULIANT® E-PX Patellas	JWH
K211877	Klassic Knee System	JWH

Device Description Summary

The Vantage® Total Ankle System is a fixed-bearing total ankle replacement device that is comprised of four components (Tibial Plate, Liner, Talar Component and Locking Component).

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Vantage® Total Ankle System 510(k) Summarv

Intended Use/Indications for Use

The Vantage Total Ankle System is indicated for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis. It is also indicated for revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present.

The Vantage Total Ankle System is indicated for cemented use only.

Indications for Use Comparison

The subject and the predicate devices have the same indications for use.

Technological Comparison

The proposed and predicate devices have the same intended use and similar basic fundamental scientific technology. The rationale for substantial equivalence of the proposed to the predicate cleared devices is based on consideration of the following aspects of the devices:

The subject and the predicate devices are composed of the similar biocompatible materials.
The subject and the predicate devices have similar design features. ●
The proposed and predicate devices are provided sterile for single use only. .
. The proposed and predicate devices conform to recognized performance standards for ankle replacement devices.

Non-Clinical and/or Clinical Tests Summary & Conclusions

The following non-clinical testing and engineering analyses were performed to demonstrate that the Vantage Total Ankle System will perform as intended and is substantially equivalent to the identified predicate devices:

Material Characterization
Wear ●
Range of Motion
Stability characteristics
Disassembly characteristics ●
Biocompatibility ●
Bacterial endotoxins ●

The differences in raw material and geometry do not change the intended use, safety, or performance requirements of the proposed devices, nor do they adversely affect their safety or effectiveness. This conclusion is based on consideration of the preclinical testing and analysis including material characterization, biocompatibility assessment and testing and mechanical analysis completed to establish substantial equivalence of the proposed devices to the predicate devices.

Regulation Number and Section

§ 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.