(30 days)
Not Found
No
The device description focuses on mechanical components (plates, screws, instruments) for bone fixation and does not mention any software, algorithms, or data processing capabilities indicative of AI/ML.
Yes
The device is described as a bone fixation device intended to facilitate arthrodesis (fusion) of ankle joints, which is a therapeutic intervention.
No
Explanation: The AlignX Ankle Fusion System is a bone fixation device intended to facilitate arthrodesis (fusion) of ankle joints. It is a treatment device, not one that diagnoses conditions.
No
The device description clearly states it is a bone fixation device consisting of plates, screws, and instruments, which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "facilitate arthrodesis of the ankle," which is a surgical procedure to fuse bones. This is a direct intervention on the body, not a test performed on samples taken from the body.
- Device Description: The device is a "bone fixation device consisting of anatomical, anterior and lateral tibia plates and various locking and non-locking screws and a set of instruments." These are physical implants and surgical tools used during surgery.
- Lack of IVD Characteristics: IVD devices are typically used to examine specimens (like blood, urine, tissue) to provide information about a person's health status, diagnose diseases, or monitor treatment. This device does none of those things.
The AlignX Ankle Fusion System is a surgical implant/device used in orthopedic surgery.
N/A
Intended Use / Indications for Use
The AlignX Ankle Fusion System is intended to facilitate arthrodesis of the ankle including tibiotalocalcaneal and tibiotalar joints.
Product codes
HRS, HWC
Device Description
The AlignX Ankle Fusion System is a bone fixation device consisting of an anatomical, anterior and lateral tibia plates and various locking and non-locking screws and a set of instruments used for implant site preparation and delivery. The plates are available in various geometries. The anterior plate is available three configurations, a slim plate and a 2-tab plate (available in two widths). A central hole in the plate allows for angled placement of a "home run" screw to obtain axial compression across the tibiotalar (TT) or (tibiotalarcalcaneal) (TTC) joints. The 2-tab plate is designed with an anterior "window" to allow autologous grafting of the TT and visualization of fusion under fluoroscopy. The lateral plate is available in two geometries, one for tibiotalar (TT) joint fusion and one for tibiotalarcalcaneal (TTC) fusions.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ankle including tibiotalocalcaneal and tibiotalar 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)
Non-clinical Testing: An engineering analysis demonstrated that the new plates and screw sizes do not introduce a new worse case in terms of strength.
Clinical Testing: No clinical testing was performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K160191, K141735, K132591, K133691
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(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). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services-USA, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The text is arranged in two lines, with "FDA U.S. FOOD & DRUG" on the top line and "ADMINISTRATION" on the bottom line.
May 23, 2018
Extremity Medical, LLC Brian Smekal VP, Regulatory Affairs and Quality Assurance 300 Interpace Parkway, Suite 410 Parsippany, New Jersey 07054
Re: K181067
Trade/Device Name: AlignX Ankle Fusion System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: April 20, 2018 Received: April 23, 2018
Dear Brian Smekal:
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 quality systems (QS) regulation (21 CFR Part 820);
1
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Katherine D. Kavlock -S
for 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)
Device Name AlignX Ankle Plating System
Indications for Use (Describe)
The AlignX Ankle Fusion System is intended to facilitate arthrodesis of the ankle including tibiotalocalcaneal and tibiotalar joints.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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
Special 510(k) Summary of Safety and Effectiveness:
AlignX Ankle Fusion System
| Submitter | Extremity Medical, LLC.
300 Interpace Parkway, Suite 410
Parsippany, NJ 07054 |
|---------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Brian Smekal, MS, RAC
VP, Regulatory Affairs and Quality Assurance
Phone: (973) 588-8988
Email: bsmekal@extremitymedical.com |
| Date Prepared | May 7, 2018 |
| Trade Name | AlignX Ankle Fusion Plate System |
| Classification
Name and
Number | 21 CFR 888.3030 - Single/multiple component metallic bone fixation appliances and
accessories; 21 CFR 888.3040 - Smooth or threaded metallic bone fixation fastener |
| Product Code | HRS (plate, fixation, bone); HWC (screw, fixation, bone) |
| Predicate
Devices | K160191 - Extremity Medical Align Ankle Fusion Plate
K141735 – Arthrex Ankle Fusion Plating System
K132591 - WMT Maxlock Extreme
K133691 - Osteomed Exremilock |
| Device
Description | The AlignX Ankle Fusion System is a bone fixation device consisting of an anatomical,
anterior and lateral tibia plates and various locking and non-locking screws and a set of
instruments used for implant site preparation and delivery. The plates are available in
various geometries. The anterior plate is available three configurations, a slim plate and a 2-
tab plate (available in two widths). A central hole in the plate allows for angled placement of
a "home run" screw to obtain axial compression across the tibiotalar (TT) or
(tibiotalarcalcaneal) (TTC) joints. The 2-tab plate is designed with an anterior "window" to
allow autologous grafting of the TT and visualization of fusion under fluoroscopy. The
lateral plate is available in two geometries, one for tibiotalar (TT) joint fusion and one for
tibiotalarcalcaneal (TTC) fusions. |
| Indications for
use | The AlignX Ankle Fusion System is intended to facilitate arthrodesis of the ankle including
tibiotalocalcaneal and tibiotalar joints. |
| Statement of
Technological
Comparison | The AlignX Ankle Fusion System and predicate devices are equivalent in terms of
indications for use, design, and material mechanical properties. |
| Non-clinical
Testing | An engineering analysis demonstrated that the new plates and screw sizes do not introduce a
new worse case in terms of strength. |
| Clinical Testing | No clinical testing was performed. |
| Conclusion | The AlignX Ankle Fusion System is substantially equivalent to its predicate device. This
conclusion is based upon indications for use, principles of operation, design, and mechanical
test data. |
4