(91 days)
Not Found
No
The document describes a mechanical prosthetic device and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is a total ankle replacement system designed to treat ankle arthritis by replacing the ankle joint, which aims to reduce pain, restore alignment, and allow movement. These actions fall under the definition of therapeutic intervention.
No
The device is a total ankle replacement system designed to treat ankle arthritis by replacing the joint with a prosthesis. It is a therapeutic device, not a diagnostic one.
No
The device description clearly states it is a prosthesis composed of physical components (tibial component, talar component, insert) intended for surgical implantation. This is a hardware medical device.
Based on the provided information, the Cadence Total Ankle System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- The Cadence Total Ankle System is a surgical implant designed to replace the ankle joint within the human body. Its purpose is to treat ankle arthritis by physically replacing the damaged joint, not by analyzing biological samples.
The description clearly states its function as a prosthesis implanted into the patient to restore movement and reduce pain, which is characteristic of a surgical device, not an IVD.
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)
The 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.
Product codes (comma separated list FDA assigned to the subject device)
HSN
Device Description
The Integra® Total Ankle Replacement 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 prosthesis is composed of a tibial component, a talar component and an insert. Both the tibial component and talar component are secured to patient anatomy via bone cement; the intermediate insert is rigidly fixed to the tibial component intra-operatively. When all three components are implanted, the intermediate insert acts as a bearing along the talar component, enabling flexion and extension movement at the replaced joint.
Components are available in a variety of sizes and design configurations intended for both primary and revision applications.
For marketing purposes the Integra Total Ankle Replacement System will be released to market as the Cadence Total Ankle System.
Implants:
Talar Dome Components
The Talar domes are manufactured from cobalt chrome and are offered in 5 sizes with Left and Right hands. They have a highly polished articular surface and a titanium plasma spray under surface.
Tibial Travs
The Tibial Trays are manufactured from titanium alloy and are offered in 9 sizes with Left and Right hands. Sizes 1 through 4 come in both standard and "X" versions with the "X" version having a larger AP dimension. The size 5 only comes in the standard version The trays have a smooth finish top and a titanium plasma spray under surface.
Inserts
The inserts are made of cross-linked polyethylene GUR1020 UHMWPE and are offered in 5 sizes with Left and Right hands. There are 3 versions of the inserts including neutral, Anterior Biased, and Posterior Biased. They all come in thicknesses from 6mm to 12mm in 1 mm increments.
Reusable Instruments:
Tibial Alignment Guides Tibial and Talar sizing Guides Tibial and Talar cutting Guides Talar Reaming guides Tibial Trays, Talar Domes and insert trials Tibial and Talar impactors and extractors Insert Inserter Retraction instrumentations
Pins, drills and reamers
Materials:
Implants:
The Talar dome components are made out of Cobalt Chrome alloy (CoCr) per NF ISO 5832-4 and ASTM F75, with a porous titanium coating (Ti).
The tibial tray components are made out of titanium alloy (Ti) Ti-6A1-4V ELI Per ASTM F136, with a porous titanium coating (Ti).
The insert is made out of cross-linked polyethylene GUR1020 UHMWPE, per ISO 5834-2 and ASTM F648.
Instrumentation:
The reusable instrumentation is manufactured from biocompatible materials, including stainless steel, Radel, and silicone.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The performance of the Integra Total Ankle Replacement Systemwas verified to be statistically equivalent to that of the predicate device. The predicate construct and Integra Total Ankle Replacement Systemconstruct were tested both dynamically and statically. The stiffness of the 2 systems was compared and was statistically equivalent. A summary of the objective, acceptance criteria, results, and conclusions, as well as the detailed test reports can be found in Section 36.
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.
Not Found
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/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three faces in profile, stacked on top of each other. The faces are oriented to the right. The logo is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in all caps.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 31, 2015
Ascension Orthopedics % Mr. Steve Brown CoorsTek Medical 560 West Golf Course Road Providence, Utah 84332
Re: K151459
Trade/Device Name: Integra Total Ankle Replacement 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 2, 2015 Received: June 3, 2015
Dear Mr. Brown
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 Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the
1
Page 2 - Mr. Steve Brown
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" (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 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
2
Indications for Use
510(k) Number (if known) K151459
Device Name
Integra Total Ankle Replacement System
Indications for Use (Describe) 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)
The Cadence Total Ankle System is also indicated for revision surgeries following failed total ankle replacement and non-union of ankle arthrodesis, provided sufficient bone stock is present.
Note: In the United States, this device is intended for cemented use only.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Section 4: 510(k) SUMMARY
Device Trade Name: Integra Total Ankle Replacement System
Date: May 15, 2015
Sponsor:
Integra LifeSciences Corporation
Contact Person:
Integra Life Sciences Corp Frederic Testa Director, Regulatory Affairs 311 Enterprise Drive Plainsboro, NJ 08536 609-936-3630 frederic.testa@integralife.com
Manufacturer:
Ascension Orthopedics 8700 Cameron Road, Suite 100 Austin, TX 78754 609-936-3630 frederic.testa@integralife.com
| Common Name: | Total Ankle Replacement Device |
|---|---|
| Device Classification: | Class II |
| Classification Name: | Ankle joint metal/polymer semi-constrained cemented prosthesis |
| (21 CFR 888.3110) | |
| Regulation: | Ankle joint metal/polymer semi-constrained cemented prosthesis |
| (21 CFR 888.3110) | |
| Device Regulation Panel: | Orthopedic |
| Device Product Code: | Orthopedic HSN |
4
Device Description:
The Integra® Total Ankle Replacement 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 prosthesis is composed of a tibial component, a talar component and an insert. Both the tibial component and talar component are secured to patient anatomy via bone cement; the intermediate insert is rigidly fixed to the tibial component intra-operatively. When all three components are implanted, the intermediate insert acts as a bearing along the talar component, enabling flexion and extension movement at the replaced joint.
Components are available in a variety of sizes and design configurations intended for both primary and revision applications.
For marketing purposes the Integra Total Ankle Replacement System will be released to market as the Cadence Total Ankle System.
Implants:
Talar Dome Components
The Talar domes are manufactured from cobalt chrome and are offered in 5 sizes with Left and Right hands. They have a highly polished articular surface and a titanium plasma spray under surface.
Tibial Travs
The Tibial Trays are manufactured from titanium alloy and are offered in 9 sizes with Left and Right hands. Sizes 1 through 4 come in both standard and "X" versions with the "X" version having a larger AP dimension. The size 5 only comes in the standard version The trays have a smooth finish top and a titanium plasma spray under surface.
Inserts
The inserts are made of cross-linked polyethylene GUR1020 UHMWPE and are offered in 5 sizes with Left and Right hands. There are 3 versions of the inserts including neutral, Anterior Biased, and Posterior Biased. They all come in thicknesses from 6mm to 12mm in 1 mm increments.
Reusable Instruments:
Tibial Alignment Guides Tibial and Talar sizing Guides Tibial and Talar cutting Guides Talar Reaming guides Tibial Trays, Talar Domes and insert trials Tibial and Talar impactors and extractors Insert Inserter Retraction instrumentations
5
Pins, drills and reamers
Materials:
Implants:
The Talar dome components are made out of Cobalt Chrome alloy (CoCr) per NF ISO 5832-4 and ASTM F75, with a porous titanium coating (Ti).
The tibial tray components are made out of titanium alloy (Ti) Ti-6A1-4V ELI Per ASTM F136, with a porous titanium coating (Ti).
The insert is made out of cross-linked polyethylene GUR1020 UHMWPE, per ISO 5834-2 and ASTM F648.
Instrumentation:
The reusable instrumentation is manufactured from biocompatible materials, including stainless steel, Radel, and silicone.
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)
The 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.
Technological Characteristics:
There are no technological characteristics that raise new issues of safety or effectiveness.
Assessment of performance data:
The performance of the Integra Total Ankle Replacement Systemwas verified to be statistically equivalent to that of the predicate device. The predicate construct and Integra Total Ankle Replacement Systemconstruct were tested both dynamically and statically. The stiffness of the 2 systems was compared and was statistically equivalent. A summary of the objective, acceptance criteria, results, and conclusions, as well as the detailed test reports can be found in Section 36.
6
Legally Marketed Predicate Device:
Wright Medical INBONE™ Total Ankle System (K100886)
Predicate Indications for Use:
The Wright Medical INBONE™ Total Ankle System ( K100886) is indicated for patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis.
The Integra Total Ankle Replacement System is additionally indicated for patients with a failed previous ankle surgery.
CAUTION: The ankle prosthesis is intended for cement use only.
The indications are similar to the legally marketed predicate device.
Purpose:
The purpose of this Traditional 510(k) submission is to gain clearance for the Integra Total Ankle Replacement System.
Conclusions:
Based upon the similarities of the Integra Total Ankle Replacement System and the predicate devices studied, the safety and effectiveness of the Integra Total Ankle Replacement System is substantially equivalent to the predicate devices referenced.