(91 days)
K123954 INFINITY™ Total Ankle & K10088 INBONE® II Total Ankle System
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No
The summary describes a mechanical implant for ankle replacement and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is a total ankle replacement indicated for patients with damaged ankle joints due to severe arthritis or failed previous ankle surgery, which serves to treat a medical condition.
No
This device is a total ankle replacement implant designed to replace damaged ankle joints, not to diagnose a condition.
No
The device description clearly states it is a total ankle replacement implant made of several physical components (tibial stem, tibial tray, poly bearing, talar dome, talar stem). This indicates it is a hardware medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The provided text describes a total ankle replacement implant. This is a surgical device implanted into the body to replace a damaged joint.
- Intended Use: The intended use is to replace damaged ankle joints in patients with arthritis or failed previous surgeries. This is a therapeutic intervention, not a diagnostic test.
The description clearly indicates a device used within the body for treatment, not a device used outside the body to analyze samples for diagnostic purposes.
N/A
Intended Use / Indications for Use
The INBONE® Total Ankle is indicated for patients with ankle joints damaged by severe rheumatoid, posttraumatic, or degenerative arthritis. The INBONE® Total Ankle is additionally indicated for patients with a failed previous ankle surgery. CAUTION: The ankle prosthesis is intended for cemented use only.
Product codes (comma separated list FDA assigned to the subject device)
HSN
Device Description
The INBONE® implant is a total ankle replacement (TAR) that is made of several specific components. A key concept of the INBONE® device is its modularity. Based on patient anatomy, a number of component sizes can be optioned for best fit. These components include the tibial stem components, the tibial tray, the poly bearing, the talar dome, and the talar stem.
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
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Description of the training set, sample size, data source, and annotation protocol
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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)
Performance testing and engineering analysis related to articular shear stability, contact pressure, and the lock detail supports the equivalence of the subject device and shows that no new worse-case devices are introduced in this system. The safety and effectiveness of the INBONE® Total Ankle Line Extension is adequately supported by the testing rationales, substantial equivalence information, materials information, and comparison of design characteristics provided within this premarket notification.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
K123954 INFINITY™ Total Ankle & K10088 INBONE® II Total Ankle System
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.
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Image /page/0/Picture/2 description: The image shows the word "WRIGHT." in a bold, sans-serif font. Below the word is a stylized graphic that appears to be two overlapping, elongated triangles pointing in opposite directions. The image is black and white and has a slightly distressed or textured appearance.
Wright Medical Technology, Inc. 5677 Airline Road Arlington, TN 38002 www.wmt.com
510(K) SUMMARY
In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807.92, this information serves as a Summary of Safety and Effectiveness for the INBONE® Total Ankle System Line Extension.
| (a)(1). Submitted By: | Wright Medical Technology, Inc.
5677 Airline Road
Arlington, TN 38002 |
|------------------------------------|-------------------------------------------------------------------------------------------------|
| Date: | December 3, 2013 |
| Contact Person: | Val Myles
Regulatory Affairs Specialist I
Office - (901) 290-5162
Fax - (901) 867-4190 |
| (a)(2). Proprietary Name: | INBONE® Total Ankle System |
| Common Name: | Ankle Prosthesis |
| Classification Name and Reference: | 21 CFR 888.3110 – Class II |
| Device Product Code, Device Panel: | HSN: Ankle Prosthesis |
| (a)(3). Predicate Device: | K123954 INFINITY™ Total Ankle & K10088
INBONE® II Total Ankle System |
(a)(4). Device Description
The INBONE® implant is a total ankle replacement (TAR) that is made of several specific components. A key concept of the INBONE® device is its modularity. Based on patient anatomy, a number of component sizes can be optioned for best fit. These components include the tibial stem components, the tibial tray, the poly bearing, the talar dome, and the talar stem.
(a)(5). Intended Use
The INBONE® Total Ankle is indicated for patients with ankle joints damaged by severe rheumatoid, posttraumatic, or degenerative arthritis. The INBONE® Total Ankle is additionally indicated for patients with a failed previous ankle surgery. CAUTION: The ankle prosthesis is intended for cemented use only.
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(a)(6). Technological Characteristics Comparison
The INBONE® Total Ankle Line Extension is technologically substantially equivalent to the predicates. A summary of the changes is shown below:
- Addition of a Size 1 Talar Dome and Size 1 + Poly Bearing .
- . Addition of thicker poly bearings for revisions
- Trials for all of the poly bearings in this line extension and the size 1 talar dome .
- Mid and top tibial stem pieces with the plasma coating removed .
(b)(1). Substantial Equivalence - Non-Clinical Evidence
Performance testing and engineering analysis related to articular shear stability, contact pressure, and the lock detail supports the equivalence of the subject device and shows that no new worse-case devices are introduced in this system. The safety and effectiveness of the INBONE® Total Ankle Line Extension is adequately supported by the testing rationales, substantial equivalence information, materials information, and comparison of design characteristics provided within this premarket notification.
(b)(2). Substantial Equivalence - Clinical Evidence
N/A
(b)(3). Substantial Equivalence - Conclusions
The design characteristics of the subject system do not affect the safety or effectiveness of the system. From the evidence submitted in this 510(k), the subject devices can be expected to perform substantially equivalent to the predicate system.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure or a caduceus, a symbol often associated with medicine and healthcare.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 20, 2014
Wright Medical Technology, Incorporated Val Myles Regulatory Affairs Specialist I 5677 Airline Road Arlington, Tennessee 38002
Re: K133585
Trade/Device Name: InBone® Total Ankle Line Extension Regulation Number: 21 CFR 888.3110 Regulation Name: Ankle joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: HSN Dated: January 16, 2014 Received: January 24, 2014
Dear Val Myles:
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 (reporting of medical
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device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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.
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Lori A. Wiggins
- 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
510(k) Number (if known) K133585
Device Name
INBONE® Total Ankle Line Extension
Indications for Use (Describe)
The INBONE® Total Ankle is indicated for patients with ankle joints damaged by severe rheumatic, or degenerative arthritis.
The INBONE® Total Ankle is additionally indicated for patients with a failed previous ankle surgery.
CAUTION: The ankle prosthesis is intended 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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Division
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