(68 days)
No
The summary describes a mechanical implant device and its components, focusing on material changes and geometric modifications. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes.
This device is designed to replace damaged ankle joints due to severe arthritis, which is a therapeutic intervention.
No
The device is a total ankle replacement system, which is an implant used for treatment of damaged ankle joints, not for diagnosing a condition.
No
The device description clearly states it is comprised of four physical components (Tibial Plate, Liner, Talar Component, and Locking Component) and describes material and geometric changes, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a total ankle replacement system for treating damaged ankle joints. This is a surgical implant, not a diagnostic test performed on samples from the body.
- Device Description: The description details the components of a prosthetic ankle joint.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific markers, or providing diagnostic information. The performance studies focus on mechanical properties, wear, range of motion, and biocompatibility, which are relevant to surgical implants.
Therefore, the Vantage Total Ankle System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
HSN
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Ankle joints
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The text is arranged in two lines, with "FDA" being larger and bolder than the rest of the text.
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
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,
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 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.
| 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 Court
Gainesville FL, 32653
Phone: (352) 377-1140
Fax: (352) 378-2617 |
|----------------------|----------------------------------------------------------------------------------------------------------------|
| Applicant Contact: | Liz Howell
Senior Regulatory Specialist
Telephone: (352) 377-1140
Fax: (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 cemented
prosthesis |
| 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).
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.
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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.