(30 days)
The AlignX Ankle Fusion System is intended to facilitate arthrodesis of the ankle including tibiotalocalcaneal and tibiotalar joints.
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.
The provided text is a 510(k) summary for a medical device called the "AlignX Ankle Fusion System." This summary does not include acceptance criteria or the results of a study proving a device meets acceptance criteria. Instead, it focuses on demonstrating substantial equivalence to predicate devices through engineering analysis and the assertion that no clinical testing was performed.
Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample size, ground truth, or expert qualifications based on the given text.
The document states:
- "No clinical testing was performed."
- "An engineering analysis demonstrated that the new plates and screw sizes do not introduce a new worse case in terms of strength."
This indicates that equivalence was established through non-clinical testing (engineering analysis) and comparison to predicate devices, rather than through a study with acceptance criteria often seen with performance claims for AI/ML devices or diagnostic tools.
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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);
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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
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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)
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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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Special 510(k) Summary of Safety and Effectiveness:
AlignX Ankle Fusion System
| Submitter | Extremity Medical, LLC.300 Interpace Parkway, Suite 410Parsippany, NJ 07054 |
|---|---|
| Contact Person | Brian Smekal, MS, RACVP, Regulatory Affairs and Quality AssurancePhone: (973) 588-8988Email: bsmekal@extremitymedical.com |
| Date Prepared | May 7, 2018 |
| Trade Name | AlignX Ankle Fusion Plate System |
| ClassificationName andNumber | 21 CFR 888.3030 - Single/multiple component metallic bone fixation appliances andaccessories; 21 CFR 888.3040 - Smooth or threaded metallic bone fixation fastener |
| Product Code | HRS (plate, fixation, bone); HWC (screw, fixation, bone) |
| PredicateDevices | K160191 - Extremity Medical Align Ankle Fusion PlateK141735 – Arthrex Ankle Fusion Plating SystemK132591 - WMT Maxlock ExtremeK133691 - Osteomed Exremilock |
| DeviceDescription | 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 ofinstruments used for implant site preparation and delivery. The plates are available invarious 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 ofa "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" toallow autologous grafting of the TT and visualization of fusion under fluoroscopy. Thelateral plate is available in two geometries, one for tibiotalar (TT) joint fusion and one fortibiotalarcalcaneal (TTC) fusions. |
| Indications foruse | The AlignX Ankle Fusion System is intended to facilitate arthrodesis of the ankle includingtibiotalocalcaneal and tibiotalar joints. |
| Statement ofTechnologicalComparison | The AlignX Ankle Fusion System and predicate devices are equivalent in terms ofindications for use, design, and material mechanical properties. |
| Non-clinicalTesting | An engineering analysis demonstrated that the new plates and screw sizes do not introduce anew 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. Thisconclusion is based upon indications for use, principles of operation, design, and mechanicaltest data. |
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§ 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.