(211 days)
No
The summary describes a system of orthopedic implants for total ankle replacement and mentions additive manufacturing and minor geometrical modifications, but there is no mention of AI or ML technology.
Yes
The device is an orthopedic implant system intended for total ankle replacement due to severe arthritis or failed previous reconstructions, directly treating a medical condition.
No
This device is a system of orthopedic implants for total ankle replacement, indicated for patients with damaged ankle joints. It is a treatment device, not a diagnostic one.
No
The device description clearly states it is a system of orthopedic implants including physical components like Tibial Plates, Tibial Inserts, Talar Components, and Locking Clips. The performance studies also focus on the mechanical properties and testing of these physical implants.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for replacing damaged ankle joints due to arthritis or failed reconstructions. This is a surgical implant, not a diagnostic test performed on samples from the body.
- Device Description: The description details orthopedic implants (Tibial Plates, Tibial Inserts, Talar Components, Locking Clips) used in total ankle replacement surgery.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific markers, or providing diagnostic information about a patient's condition.
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 system of orthopedic implants intended for total ankle replacement. The system includes Tibial Plates, Tibial Inserts, Talar Components, and Locking Clips. This submission proposes three new components as line extensions of the Vantage Total Ankle System, which are modifications of their respective predicate components:
- 3D Tibial Plates
- 3D+ Tibial Plates
- 3D/3D+ Locking Clips
The proposed devices have the same indications for use and similar design characteristics as their predicate devices (cleared under K152217). The proposed tibial plates differ from the predicate in that they are additively manufactured, have minor geometrical modifications, and are offered in additional sizes. The proposed locking clips differ from the predicate in that they are offered in additional sizes.
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 Exactech® Vantage® 3D Tibial Plates, 3D+ Tibial Plates and 3D/3D+ Locking Clips function as intended and are substantially equivalent to the identified predicate devices:
- Tibial Plate Fatigue Testing per ASTM F2665
- Tibial Plate Fixation Stability Testing
- Locking Mechanism Fatigue Testing
- Residual Particulate Count Studies
- Porous Surface Characterization Testing
- Stereological Evaluation per ASTM F1854
- Static Shear Testing per ASTM F1044
- Tension Testing per ASTM F1147
- Abrasion Resistance Testing per ASTM F1978
- Shear Fatigue Testing per ASTM F1160
- Compression Testing
The results of this non-clinical testing show that the strength of the Vantage 3D Tibial Plates, 3D Tibial Plates and 3D/3D Locking Clips is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices. Pyrogenicity testing was also conducted and demonstrates that the endotoxin limit is less than 20 EU/device.
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.
0
Image /page/0/Picture/0 description: The image shows 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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 12, 2023
Exactech, Inc. Pedro Ravelo Regulatory Affairs Specialist 2320 NW 66th Ct. Gainesville, Florida 32653
Re: K230717
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: September 13, 2023 Received: September 13, 2023
Dear Pedro Ravelo:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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
2
Indications for Use
510(k) Number (if known) K230717
Device Name Exactech® 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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3
Exactech® Vantage® Total Ankle System Traditional 510(k) - 510(k) Summary
| | | Exactech, Inc.
2320 NW 66th Court
Gainesville, FL 32653 |
|----------------------|--|----------------------------------------------------------------------------------|
| Sponsor | | Phone: (352) 377-1140
Fax: (352) 378-2617
FDA Establishment Number 1038671 |
| Contact Person | | Pedro Ravelo
Regulatory Affairs Specialist |
| Date | | 14 March 2023 |
| Proprietary Name | | Exactech® Vantage® Total Ankle System |
| Common Name | | Ankle Arthroplasty Prosthesis |
| Regulation Number / | | 21 CFR 888.3110 – Ankle joint metal/polymer semi- |
| Classification Name | | constrained cemented prosthesis |
| Device Class | | Class II |
| Product Code | | HSN - Prosthesis, Ankle, Semi-Constrained, Cemented,
Metal/Polymer |
| Classification Panel | | Orthopedic |
510(K) SUMMARY
Device Description
The Vantage® Total Ankle System is a system of orthopedic implants intended for total ankle replacement. The system includes Tibial Plates, Tibial Inserts, Talar Components, and Locking Clips. This submission proposes three new components as line extensions of the Vantage Total Ankle System, which are modifications of their respective predicate components:
- 3D Tibial Plates
- 3D+ Tibial Plates ●
- 3D/3D+ Locking Clips ●
The proposed devices have the same indications for use and similar design characteristics as their predicate devices (cleared under K152217). The proposed tibial plates differ from the predicate in that they are additively manufactured, have minor geometrical modifications, and are offered in additional sizes. The proposed locking clips differ from the predicate in that they are offered in additional sizes.
4
Exactech® Vantage® Total Ankle System Traditional 510(k) - 510(k) Summarv
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.
Legally Marketed Devices to Which Substantial Equivalence Is Claimed
| 510(k) Number | Trade or Proprietary Model Name | Manufacturer |
|---|---|---|
| K152217 | Exactech® Vantage® Total Ankle System | Exactech, Inc |
Legally Marketed Reference Devices
| 510(k) Number | Trade or Proprietary Model Name | Manufacturer |
|---|---|---|
| K192097 | Exactech® Equinoxe® Stemless Humeral Components | Exactech, Inc |
Substantial Equivalence Discussion
The proposed Vantage 3D Tibial Plates, 3D* Tibial Plates, and 3D/3D* Locking Clips are made from Ti-6A1-4V ELI that conforms to ASTM F3001-14 or ASTM F136-13. The subject devices and their respective predicates have similar technological characteristics and the minor differences do not raise any different issues of safety and effectiveness. The rationale for substantial equivalence is based on consideration of the following device use, design characteristics, and performance requirements:
Indications for Use
The proposed and predicate devices have the same indications for use.
Materials
The proposed and predicate devices are composed of the same or similar biocompatible materials.
Design Features The proposed and predicate devices have the same or similar design features.
Dimensions
The proposed and predicate devices are dimensionally comparable.
Sterilization
The proposed and predicate devices are provided sterile for single use only.
Performance Requirements
The proposed and predicate devices conform to the same recognized performance standards for total ankle replacement devices.
5
Exactech® Vantage® Total Ankle System Traditional 510(k) - 510(k) Summary
Non-Clinical Testing
The following non-clinical testing and engineering analyses were performed to demonstrate that the Exactech® Vantage® 3D Tibial Plates, 3D+ Tibial Plates and 3D/3D+ Locking Clips function as intended and are substantially equivalent to the identified predicate devices:
- Tibial Plate Fatigue Testing per ASTM F2665 ●
- Tibial Plate Fixation Stability Testing ●
- Locking Mechanism Fatigue Testing ●
- Residual Particulate Count Studies
- Porous Surface Characterization Testing ●
- Stereological Evaluation per ASTM F1854 O
- Static Shear Testing per ASTM F1044 O
- Tension Testing per ASTM F1147 O
- Abrasion Resistance Testing per ASTM F1978 O
- Shear Fatigue Testing per ASTM F1160 O
- Compression Testing o
The results of this non-clinical testing show that the strength of the Vantage 3D Tibial Plates, 3D Tibial Plates and 3D/3D Locking Clips is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices. Pyrogenicity testing was also conducted and demonstrates that the endotoxin limit is less than 20 EU/device.
Conclusion
Based on consideration of indications for use, technological characteristics, and results of non-clinical testing, it was concluded that the Exactech® Vantage® Total Ankle System is substantially equivalent to the identified predicate device.