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.

Device Description

Exactech Vantage Total Ankle System is a fixed-bearing total ankle replacement device that is comprised of four sub-components, a tibial plate, a tibial insert, a locking component, and a highly polished talar component that are assembled to create the subject total ankle replacement system. The tibial plate is manufactured from titanium alloy (Ti-6Al-4V ELI) with commercially pure titanium coating on the bone-contacting surface. The tibial insert is made of ultra-high molecular weight polyethylene. The highly polished talar component is manufactured from cobalt-chromium alloy (Co-28Cr-6Mo) with commercially pure titanium coating on the bone-contacting surface. The locking component is made of titanium alloy (Ti-6Al-4V ELI). Each of the four sub-components is offered in multiple sizes to accommodate the various anatomical needs of a patient's ankle joint. With the exception of the locking component, all components are anatomically designed and offered in left and right implant components. The overall design goals of the Exactech Vantage Total Ankle System are to maximize bony support while allowing impingement-free range of motion, and provide anterior/posterior, medial/lateral, and rotational stability when implanted in the resected/prepared distal tibia and proximal talus. Exactech Vantage Total Ankle System device is indicated for cemented use only.

The Exactech Vantage Total Ankle System is accompanied by a complete instrumentation set including trial and rasp/cutting block system to assist surgeons in implantation of the device.

AI/ML Overview

This FDA 510(k) summary describes a new medical device, the Exactech® Vantage™ Total Ankle System, and establishes its substantial equivalence to previously cleared predicate devices. The document does not describe a study conducted to prove the device meets acceptance criteria related to AI or algorithm performance; rather, it details non-clinical testing to demonstrate mechanical and design equivalence for a physical orthopedic implant.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, data provenance, expert qualifications, ground truth, adjudication methods, and MRMC/standalone studies is not present in the provided text, as these are typically associated with performance evaluations of AI/ML or diagnostic devices.

The document focuses on:

Device Description: A fixed-bearing total ankle replacement system made of specific materials (titanium alloy, ultra-high molecular weight polyethylene, cobalt-chromium alloy).
Indications for Use: Patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis, and for revision of failed previous reconstructions. Indicated for cemented use only.
Substantial Equivalence: Claimed based on similar indications for use, materials, design features, dimensions, sterilization, and conformity to recognized performance standards compared to predicate devices (Salto Talaris™ Total Ankle Prosthesis and INFINITY® Total Ankle System).
Non-Clinical Testing: A list of mechanical and engineering tests performed to support substantial equivalence (e.g., sizing studies, locking integrity testing, fatigue analysis, wear evaluation, contact area/stress, constraint evaluation, bone stability, range of motion study, finite element analysis).

In summary, none of the requested information about acceptance criteria for AI/ML device performance validation is available in the provided text. The document pertains to a traditional orthopedic implant's 510(k) submission, where the "acceptance criteria" are implied by conformity to recognized standards and successful completion of the listed non-clinical mechanical tests, demonstrating equivalence to predicates.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 10, 2016

Exactech Incorporated Shing Jen Tai, Ph.D. Senior Regulatory Affairs Specialist 2320 N.W. 66th Court Gainesville, Florida 32653

Re: K152217

Trade/Device Name: Exactech® 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: February 16, 2016 Received: February 17, 2016

Dear Dr. Jen Tai:

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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES	K152217 Page 1 of 1
Food and Drug Administration	Form Approved: OMB No. 0910-0120
Indications for Use	Expiration Date: January 31, 2017
	See PRA Statement below.
510(k) Number ( if known )	K152217
Device Name	Exactech Vantage Total Ankle System
Indications for Use ( Describe )	The Vantage TM 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 TM 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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Exactech® Vantage™ Total Ankle System Traditional 510(k)

510(k) Summary

Company:	Exactech®, Inc2320 NW 66th CourtGainesville, FL 32653
Date:	March 4, 2016
Contact Person:	Shing Jen Tai, PhDSr. Regulatory Affairs Specialist
	Phone: (352) 327-4638Fax: (352) 378-2617
Proprietary Name:	Exactech® VantageTM Total Ankle System
Common Name:	Total Ankle Prosthesis
Classification Name:	21 CFR 888.3110, Ankle Joint Metal/Polymer Semi-Constrained Cemented Prosthesis
	Class II
Product Code:	HSN

Legally Marketed Device to Which Substantial Equivalence Is Claimed:

Salto Talaris™ Total Ankle Prosthesis (K090076) from Tornier
INFINITY® Total Ankle System (K123954, and K140749 line extension to ● devices cleared in K123954) from Wright Medical Technology, Inc.

Device Description

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Exactech® Vantage™ Total Ankle System Traditional 510(k)

medial/lateral, and rotational stability when implanted in the resected/prepared distal tibia and proximal talus. Exactech Vantage Total Ankle System device is indicated for cemented use only.

The Exactech Vantage Total Ankle System is accompanied by a complete instrumentation set including trial and rasp/cutting block system to assist surgeons in implantation of the device.

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.

Summary of Technological Characteristics

The rationale for substantial equivalence is based on consideration of the following device use and characteristics:

. Indications for Use. The proposed Exactech Vantage Total Ankle System and the predicate devices have similar and comparable indications for use.
Materials/Surface Coatings. The proposed Exactech Vantage Total Ankle . System and the predicate devices are composed of same or similar, biocompatible substrate materials, and the same surface coatings for permanent implants.
. Design Features. The proposed Exactech Vantage Total Ankle System and the predicate devices share similar design features.
Dimensions. The proposed Exactech Vantage Total Ankle System and the predicate devices are dimensionally comparable.
Sterilization. The proposed Exactech Vantage Total Ankle System and the predicate devices are provided sterile for single use only.
Performance Requirements. The proposed Exactech Vantage Total Ankle ● System and the predicate devices conform to recognized performance standards for total ankle joint replacement devices.

Non-Clinical Testing

The following sizing studies, mechanical testing, and modeling analyses were performed to demonstrate that the Exactech Vantage Total Ankle System performs as intended and is substantially equivalent to the identified predicate devices:

Sizing Studies
Locking integrity Testing ●
Fatigue Analysis ●
Wear Evaluation
Contact Area/Contact Stress Study ●

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Exactech® Vantage™ Total Ankle System Traditional 510(k)

Constraint Evaluation ●
. Bone Stability Testing
. Range of Motion Study
. Finite Element Analysis

Substantial Equivalence Conclusion

Based on consideration of indications for use, technological characteristics, and results of combined mechanical testing, modeling analyses, and sizing studies described above, it was concluded that Exactech Vantage Total Ankle System demonstrates substantial equivalence to the referenced 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.