(24 days)
No
The summary describes a mechanical ankle prosthesis and its components. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is designed to treat ankle arthritis and other conditions by replacing the ankle joint, which is a therapeutic intervention.
No
The device is a prosthesis designed to replace the ankle joint, not to diagnose a condition.
No
The device description clearly states it is a prosthesis composed of physical components (tibial tray, talar dome, insert) and associated instrumentation, which are hardware.
Based on the provided information, the Cadence Total Ankle System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Cadence Total Ankle System Function: The description clearly states that the Cadence Total Ankle System is a prosthesis designed to replace the ankle joint within the body. It is an implantable device used for surgical treatment of ankle arthritis.
- Lack of Specimen Analysis: There is no mention of the device analyzing any biological specimens. Its function is mechanical replacement and restoration of joint movement.
Therefore, the Cadence Total Ankle System falls under the category of a medical device (specifically, an orthopedic implant), but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Cadence Total Ankle System is designed to treat ankle arthritis through replacement of the ankle joint with a prosthesis, thereby reducing pain, restoring alignment, and allowing for movement at the replaced joint.
The Cadence Total Ankle System is indicated for use to treat:
- Systemic arthritis of the ankle (e.g. rheumatoid arthritis, hemochromatosis)
- Primary arthritis (e.g. degenerative disease)
- Secondary arthritis (e.g. post-traumatic, avascular necrosis, if minimally 2/3 of the talus is preserved)
Cadence Total Ankle System is also indicated for revision surgeries following failed total ankle replacement and non-union/mal-union of ankle arthrodesis.
Provided sufficient bone stock is present.
Note - In the United States, this device is intended for cemented use only.
Note - Outside the United States, this device is intended for cemented or cementless use.
Product codes
HSN
Device Description
The Cadence Total Ankle System is a prosthesis composed of a tibial tray, a talar dome and an insert. The tibial tray and talar dome are secured to patient anatomy. The insert is rigidly fixed to the tibial tray intra-operatively. The insert acts as a bearing along the talar dome, enabling flexion and extension movement at the replaced joint. Each of the three components is available in a variety of sizes and design configurations intended for both primary and revision surgery applications. The Cadence System also consists of various instrumentation to allow for appropriate implantation of the Cadence Prosthesis.
The scope of the Cadence System is being extended to include additional options for the talar domes. The new talar dome option features a flat cut design in comparison to the currently commercialized talar dome chamfer cut design. New instrumentation will also be introduced to aid in the implantation of the new flat cut talar dome design.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Ankle joint
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
Nonclinical Performance Data: The modified device was subjected to the following verification testing and/or analyses to establish substantial equivalence in comparison to the unmodified device.
- Constraint
- Bone Stability
- Range of Motion
- Fatigue Strength
- Contact Area and Pressure Distribution
- Wear
Clinical Performance Data: Clinical performance data is not required to demonstrate substantial equivalence to the predicate device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 contains the logo for 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, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
June 29, 2020
Integra Lifesciences Corporation Ascension Orthopedics, Inc. Cassidy Lemkau Regulatory Affairs Specialist 11101 Metric Blvd Austin, Texas 78758
Re: K201507
Trade/Device Name: Cadence 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: June 4, 2020 Received: June 5, 2020
Dear Cassidy Lemkau:
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.
1
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 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-reporting-
combination-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 medical devices and radiation-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.
Ting Song, Ph.D., R.A.C. Acting 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
2
Indications for Use
510(k) Number (if known) K201507
Device Name Cadence Total Ankle System
Indications for Use (Describe)
The Cadence Total Ankle System is designed to treat ankle arthritis through replacement of the ankle joint with a prosthesis, thereby reducing pain, restoring alignment, and allowing for movement at the replaced joint.
The Cadence Total Ankle System is indicated for use to treat:
| - Systemic arthritis of the ankle (e.g. rheumatoid arthritis, hemochromatosis) |
|---|
| - Primary arthritis (e.g. degenerative disease) |
| - Secondary arthritis (e.g. post-traumatic, avascular necrosis, if minimally 2/3 of the talus is preserved) |
Cadence Total Ankle System is also indicated for revision surgeries following failed total ankle replacement and non-union/mal-union of ankle arthrodesis.
Provided sufficient bone stock is present.
Note - In the United States, this device is intended for cemented use only.
Note - Outside the United States, this device is intended for cemented or cementless use.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X | Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
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510(k) Summary
| Sponsor | Integra Lifesciences Corp.
Ascension Orthopedics, Inc.
11101 Metric Blvd.
Austin, TX 78758 |
|-------------------------|-----------------------------------------------------------------------------------------------------------|
| Establishment
Number | 3014207283 |
| Point of Contact | Cassidy Lemkau
Regulatory Affairs Specialist
11101 Metric Blvd.
Austin, TX 78758
402-990-4239 |
| Date | 06/06/2020 |
| Trade Name | Cadence Total Ankle System |
| Common Name | Ankle Implant |
| Classification
Panel | Orthopedic |
| Classification | Class II |
| Regulation No. | 21 CFR 888.3110 |
| Regulation Name | Ankle joint metal/polymer semi-constrained cemented prosthesis |
| Product Code | HSN |
| Predicate Device | K151459
Integra Total Ankle Replacement System |
4
| Reference Device | K182878
Integra Salto Total Ankle System |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device
Description | The Cadence Total Ankle System is a prosthesis composed of a tibial tray, a talar
dome and an insert. The tibial tray and talar dome are secured to patient anatomy.
The insert is rigidly fixed to the tibial tray intra-operatively. The insert acts as a
bearing along the talar dome, enabling flexion and extension movement at the
replaced joint. Each of the three components is available in a variety of sizes and
design configurations intended for both primary and revision surgery
applications. The Cadence System also consists of various instrumentation to
allow for appropriate implantation of the Cadence Prosthesis. |
| | The scope of the Cadence System is being extended to include additional options
for the talar domes. The new talar dome option features a flat cut design in
comparison to the currently commercialized talar dome chamfer cut design. New
instrumentation will also be introduced to aid in the implantation of the new flat
cut talar dome design. |
| Intended Use/
Indications for Use | The Cadence Total Ankle System is designed to treat ankle arthritis through
replacement of the ankle joint with a prosthesis, thereby reducing pain, restoring
alignment, and allowing for movement at the replaced joint.
The Cadence Total Ankle System is indicated for use to treat:
- Systemic arthritis of the ankle (e.g. rheumatoid arthritis, hemochromatosis)
- Primary arthritis (e.g. degenerative disease)
- Secondary arthritis (e.g. post-traumatic, avascular necrosis, if minimally 2/3
of the talus is preserved)
Cadence Total Ankle System is also indicated for revision surgeries following
failed total ankle replacement and non-union/mal-union of ankle arthrodesis.
Provided sufficient bone stock is present. |
| | Note - In the United States, this device is intended for cemented use only.
Note - Outside the United States, this device is intended for cemented or
cementless use. |
5
| Nonclinical
Performance Data | The modified device was subjected to the following verification testing and/or
analyses to establish substantial equivalence in comparison to the unmodified
device.
- Constraint
- Bone Stability
- Range of Motion
- Fatigue Strength
- Contact Area and Pressure Distribution
- Wear |
|------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Clinical
Performance Data | Clinical performance data is not required to demonstrate substantial equivalence
to the predicate device. |
| Substantial
Equivalence
Conclusion | Substantial equivalence of the modified device and predicate device is based on
the following:
• The modified and predicate device have exactly the same intended use.
• Both devices operate using the same fundamental scientific technology.
• Both devices share the same functional and technological characteristics
via the same operational principles.
After evaluation of the risks and performance data, the modified device does not
raise any new issues or concerns related to safety or effectiveness. |