(154 days)
Not Found
No
The summary describes a mechanical implant for ankle replacement and does not mention any software or algorithms that would incorporate AI/ML. The use of CT scans is for anatomical analysis to support implant sizing, not for AI/ML processing.
Yes
The device is described as an ankle replacement intended to reduce pain, restore alignment, and replace movement in the ankle joint for patients with damaged joints due to arthritis or failed surgeries, which are therapeutic functions.
No
The device is an orthopedic implant (total ankle replacement) intended to restore mobility and reduce pain in patients with 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). It is a physical medical device, not software.
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, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The INBONE® Total Ankle is a surgical implant designed to replace a damaged ankle joint. It is a physical device inserted into the body during surgery.
- Intended Use: The intended use is to provide limited mobility, reduce pain, restore alignment, and replace movement in the ankle joint. This is a therapeutic purpose, not a diagnostic one.
- Lack of Diagnostic Testing: The description does not mention any testing of samples from the body or any diagnostic function.
While the device uses imaging (computed tomography scans) for planning and analysis, this is for surgical planning and assessing the device's performance, not for diagnosing a condition using a sample from the body.
N/A
Intended Use / Indications for Use
The INBONE® Total Ankle is intended to give a patient limited mobility by reducing pain, restoring alignment and replacing the flexion and extension movement in the ankle joint.
The INBONE® Total Ankle is indicated for patients with ankle joints damaged by severe rheumatoid, post-traumatic, 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 cement use only.
Product codes
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 modular components include the tibial stem components, the tibial tray, the poly bearing, the talar dome, and the talar stem. Subject of this submission is an expansion of labeling while Wright is also notifying FDA of additional implant sizes.
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)
- Performance fatigue testing has shown that the extended total tibial stem length is . substantially equivalent to previous performance tests.
- Through mechanical analysis the new tibial stem diameter and shorter total tibial stem . length do not represent a new worst-case.
- Through analysis the new poly bearings do not represent a new worst-case and are . substantially equivalent to previously licensed devices.
- Analyses of computed tomography scans were used to support the larger sized stems. .
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K051023 INBONE® Total Ankle, K103374 INBONE® Total Ankle, K100886 INBONE® II Total Ankle
Reference Device(s)
Not Found
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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K123054 12
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
MAR 4 2013
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.
| (a)(1). Submitted By: | Wright Medical Technology, Inc.
5677 Airline Road
Arlington, TN 38002 |
|------------------------------------|-----------------------------------------------------------------------------|
| Date: | September 27, 2012 |
| Contact Person: | Ryan Bormann
Regulatory Affairs Specialist II
(901) 867-4409 |
| (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: Orthopedic |
| (a)(3). Predicate Device: | K051023 INBONE® Total Ankle |
| | K103374 INBONE® Total Ankle |
| | K100886 INBONE® II Total Ankle |
(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 modular components include the tibial stem components, the tibial tray, the poly bearing, the talar dome, and the talar stem. Subject of this submission is an expansion of labeling while Wright is also notifying FDA of additional implant sizes.
(a)(5). INTENDED USE
The INBONE® Total Ankle is intended to give a patient limited mobility by reducing pain, restoring alignment and replacing the flexion and extension movement in the ankle joint.
INDICATIONS
The INBONE® Total Ankle is indicated for patients with ankle joints damaged by severe rheumatoid, post-traumatic, 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 cement use only.
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(a)(6). Technological Characteristics Comparison
(b)(1). Substantial Equivalence - Non-Clinical Evidence
- Performance fatigue testing has shown that the extended total tibial stem length is . substantially equivalent to previous performance tests.
- Through mechanical analysis the new tibial stem diameter and shorter total tibial stem . length do not represent a new worst-case.
- Through analysis the new poly bearings do not represent a new worst-case and are . substantially equivalent to previously licensed devices.
- Analyses of computed tomography scans were used to support the larger sized stems. .
(b)(2). Substantial Equivalence - Clinical Evidence
N/A
(b)(3). Substantial Equivalence - Conclusions
The design characteristics of the subject system do not raise any new types of questions of safety or effectiveness. From the evidence submitted in this 510(k), the subject device system can be expected to perform at least as well as the predicate systems.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized symbol resembling an eagle or bird in flight, positioned to the right of the text. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 4, 2013
Wright Medical Technology, Incorporated % Mr. Ryan Bormann Regulatory Affairs Specialist II 5677 Airline Road Arlington, Tennessee 38002
Re: K123059
Trade/Device Name: INBONE I® and INBONE II® Total Ankle 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 28, 2013 Received: January 30, 2013
Dear Mr. Bormann:
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Mr. Ryan Bormann
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Erin Seith
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K123059
Device Name: INBONE® I and INBONE®II Total Ankle
Indications For Use:
The INBONE® Total Ankle is indicated for patients with ankle joints damaged by severe rheumatoid, post-traumatic, 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 cement use only.
Prescription Use XXX (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Casey L. Hanley, Ph.D.
Division of Orthopaedic Devices
Concurrence of CDRH, Office of Device Evaluation (ODE)
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