(119 days)
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.
Vantage Total Ankle Flat Cut Talar Components are for use in resurfacing talar bone as one of the four components of the Exactech Vantage Total Ankle System (including tibial plate, tibial insert, locking component and talar component) intended for use in total ankle arthroplasty.
The proposed Vantage Flat Cut Talar Components represent modifications to the Vantage Total Ankle Talar Components cleared per 510(k) K152217. The proposed Vantage Total Ankle Flat Cut Talar Components are equivalent to the previously cleared talar components, but utilize one additional fixation structure and flat cut geometry on devices' bone-contacting surface rather than a curved underlying surface featured in the cleared, predicate talar components.
The proposed and predicate devices share the same fundamental scientific technology, have the same intended use, indications for use, and similar design features, employ the same materials of construction and manufacturing processes, are offered in the same product size scope, are implanted using similar surgical techniques and instrumentation, work with the same compatible Vantage Total ankle tibial plates and locking components, and, size for size, are compatible with the same tibial inserts from the previously cleared Exactech Vantage Total Ankle System.
The provided text is a 510(k) summary for a medical device, the Exactech® Vantage® Total Ankle Flat Cut Talar Components. It describes the device, its intended use, and substantial equivalence to a predicate device, focusing on non-clinical testing.
However, the document does not provide information about the acceptance criteria or a study that uses those criteria to evaluate a device's performance in the context of an AI/ML algorithm. The product described is a physical implant for ankle replacement, not a software or AI/ML-driven diagnostic tool.
Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes for test/training sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment relevant to AI/ML or algorithm performance.
The non-clinical testing mentioned (Sizing Studies, Cadaveric Study, Bone Stability Testing, Range of Motion Study, Comparative Analysis, Finite Element Analysis, Pyrogen testing) are typical for physical orthopedic implants, demonstrating biological safety, mechanical integrity, and surgical fit, rather than diagnostic accuracy or algorithmic performance against a ground truth.
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April 1, 2019
Exactech, Inc. Shing Jen Tai Senior Regulatory Affairs Specialist 2320 NW 66th Court Gainesville, Florida 32653
Re: K183343
Trade/Device Name: Exactech® Vantage® Total Ankle Flat Cut Talar Components 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 28, 2019 Received: March 4, 2019
Dear Shing 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. 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 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerelv.
Image /page/1/Picture/5 description: The image shows a digital signature. The signature is from Peter G. Allen -S. The date of the signature is 2019.04.01, and the time is 22:51:40 -04'00'.
FOR 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 Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K183343
Device Name
Exactech® Vantage® Total Ankle Flat Cut Talar Components
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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Exactech® Vantage® Total Ankle Flat Cut Talar Components Traditional 510(k) - 510(k) Summary
- Exactech, Inc. Sponsor: 2320 N.W. 66th Court Gainesville, FL 32653
Phone: (352) 377-1140 (352) 378-2617 Fax:
FDA Establishment Number 1038671
Contact: Shing Jen Tai, PhD Principal Regulatory Affairs Specialist
Date: March 27, 2019
Trade or Proprietary or Model Name(s): Exactech® Vantage® Total Ankle Flat Cut Talar Components
Common Name: Total Ankle Prosthesis
Classification Name: Ankle Joint Metal/Polymer Semi-Constrained Cemented Prosthesis
Product Code: HSN
Classification Panel: Orthopedic
Regulation Number: 21 CFR 888.3110
Device Class: II
Information on device to which substantial equivalence is claimed: 510(k) Number Trade or Proprietary Model Name Vantage® Total Ankle System K152217
Manufacturer Exactech, Inc
Information on reference device:
| 510(k) Number | Trade or Proprietary Model Name |
|---|---|
| K100886 | INBONE II Total Ankle System |
Manufacturer Wright Medical Technology, Inc
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Exactech® Vantage® Total Ankle Flat Cut Talar Components Traditional 510(k) - 510(k) Summary
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.
Device Description:
Vantage Total Ankle Flat Cut Talar Components are for use in resurfacing talar bone as one of the four components of the Exactech Vantage Total Ankle System (including tibial plate, tibial insert, locking component and talar component) intended for use in total ankle arthroplasty.
The proposed Vantage Flat Cut Talar Components represent modifications to the Vantage Total Ankle Talar Components cleared per 510(k) K152217. The proposed Vantage Total Ankle Flat Cut Talar Components are equivalent to the previously cleared talar components, but utilize one additional fixation structure and flat cut geometry on devices' bone-contacting surface rather than a curved underlying surface featured in the cleared, predicate talar components.
The proposed and predicate devices share the same fundamental scientific technology, have the same intended use, indications for use, and similar design features, employ the same materials of construction and manufacturing processes, are offered in the same product size scope, are implanted using similar surgical techniques and instrumentation, work with the same compatible Vantage Total ankle tibial plates and locking components, and, size for size, are compatible with the same tibial inserts from the previously cleared Exactech Vantage Total Ankle System.
Non-Clinical Testing:
The following testing and analyses were performed to demonstrate that the Vantage Total Ankle Flat Cut Talar Components perform as intended and are substantially equivalent to the identified predicate device.
- Sizing Studies ●
- Cadaveric Study
- Bone Stability Testing ●
- Range of Motion Study ●
- Comparative Analysis ●
- Finite Element Analysis ●
Pyrogen testing was conducted in accordance with USP <161>, USP <85>, and ANSI/AAMI ST72 to ensure the proposed Vantage Total Ankle Flat Cut Talar Components meet recommended limits per FDA's Guidance Document Submission
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Exactech® Vantage® Total Ankle Flat Cut Talar Components Traditional 510(k) – 510(k) Summary
and Review of Sterility Information in Premarket (510(k)) Submission for Devices Labeled as Sterile.
Substantial Equivalence Conclusion:
Results of the non-clinical testing and descriptive information referenced in this 510(k) submission demonstrate the proposed Vantage Total Ankle Flat Cut Talar Components are substantially equivalent to the cleared predicate Vantage Total Ankle Talar Components.
§ 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.