(81 days)
No
The summary describes a mechanical bone fixation device made of Nitinol. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The performance studies are focused on mechanical properties and biocompatibility.
Yes
The device is intended to stabilize and aid in the fixation of fractures, fusions, and osteotomies of the phalanges, which clearly indicates a therapeutic purpose.
No.
The document explicitly states that the device is a "bone fixation device intended to be permanently implanted" for stabilizing and aiding in the fixation of fractures, fusions, and osteotomies, rather than for diagnosing conditions.
No
The device description clearly states it is a physical, permanently implanted bone fixation device made of Nickel Titanium (Nitinol), provided on a handled inserter. It is not software.
Based on the provided information, the Arthrex DynaNite® PIP (Hammertoe) Implant is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to "stabilize and aid in the fixation of fractures, fusions, and osteotomies of the phalanges." This describes a surgical implant used directly on the patient's bone, not a test performed on a sample taken from the body.
- Device Description: The description details a "bone fixation device intended to be permanently implanted." This is consistent with a surgical implant.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Providing information about a patient's health status, diagnosis, or disease state based on sample analysis.
- Reagents, calibrators, or controls used in laboratory testing.
The device is clearly a surgical implant used for orthopedic fixation.
N/A
Intended Use / Indications for Use
The Arthrex DynaNite® PIP (Hammertoe) Implant is intended to stabilize and aid in the fixation of fractures, fusions, and osteotomies of the phalanges.
Product codes
HTY
Device Description
The Arthrex DynaNite PIP (Hammertoe) Implant is a Nickel Titanium (Nitinol) bone fixation device intended to be permanently implanted. The implant has a threaded end and a barbed end. The implant will be offered in 12mm, 14mm and 16 mm lengths, each available in straight and bent configurations. The implant is provided on a handled inserter and is sold as sterile, single-use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
phalanges
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
Barb Pull-out, Thread Pull-out, Static/Fatigue Cantilever Bend, Insertion Torque/Failure Torque, and Corrosion resistance testing were conduct to demonstrate that the Arthrex DynaNite PIP (Hammertoe) Implant performed statistically equivalent to the predicate device cleared under K960385. Barb Compression Force and Transformation Temperature tester were also conducted.
Bacterial Endotoxins Test (BET) was performed on the Arthrex DynaNite PIP (Hammertoe) Implant utilizing the Kinetic Chromogenic Method in accordance with ANSI/AAMI ST72:2011/(R)2016, USP , USP , EP 2.6.14. Testing was performed in compliance with US FDA good manufacturing practice (GMP) regulations 21 CFR Parts 210, 211 and 820. The testing conducted demonstrates that the Arthrex DynaNite PIP (Hammertoe) Implant meets pyrogen limit specifications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
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Build Correspondence
Image /page/0/Picture/2 description: The image contains the logos of the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). The HHS logo is on the left and features an abstract design of human figures. The FDA logo is on the right and includes the acronym "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
May 3, 2019
Arthrex Inc. Ms. Rebecca R. Homan Senior Regulatory Affairs Associate 1370 Creekside Boulevard Naples, Florida 34108-1945
Re: K190287
Trade/Device Name: Arthrex DynaNite® PIP (Hammertoe) Implant Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HTY Dated: April 15, 2019 Received: April 17, 2019
Dear Ms. Homan:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 comprehensive regulatory information about medical devices and radiation-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,
for CAPT Raquel Peat, PhD, MPH, USPHS Director Office of Health Technology 6 Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K190287
Device Name Arthrex DynaNite® PIP (Hammertoe) Implant
Indications for Use (Describe)
The Arthrex DynaNite® PIP (Hammertoe) Implant is intended to stabilize and aid in the fixation of fractures, fusions, and osteotomies of the phalanges.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary or 510(k) Statement
| Date Prepared | April 12, 2019 |
|---|---|
| Submitter | Arthrex Inc. |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 | |
| Contact Person | Rebecca R. Homan |
| Senior Regulatory Affairs Associate | |
| 1-239-643-5553, ext. 73429 | |
| rebecca.homan@arthrex.com | |
| Name of Device | Arthrex DynaNite® PIP (Hammertoe) Implant |
| Common Name | Bone Fixation Fasteners |
| Product Code | HTY |
| Classification Name | 21 CFR 888.3040: Smooth or threaded metallic bone fixation fastener |
| Regulatory Class | II |
| Predicate Device | K170326: dynaMX Intramedullary Implant (Primary Predicate) |
| K960385: DePuy Sterile Kirschner Wires and Steinmann Pins (Reference Predicate) | |
| K172052: Arthrex DynaNite Nitinol Staple (Reference Predicate) | |
| Purpose of Submission | This Traditional 510(k) premarket notification is submitted to obtain clearance for |
| the Arthrex DynaNite PIP (Hammertoe) Implant. | |
| Device Description | The Arthrex DynaNite PIP (Hammertoe) Implant is a Nickel Titanium (Nitinol) |
| bone fixation device intended to be permanently implanted. The implant has a | |
| threaded end and a barbed end. The implant will be offered in 12mm, 14mm and | |
| 16 mm lengths, each available in straight and bent configurations. The implant is | |
| provided on a handled inserter and is sold as sterile, single-use. | |
| Indications for Use | The Arthrex DynaNite PIP (Hammertoe) Implant is intended to stabilize and aid in |
| the fixation of fractures, fusions, and osteotomies of the phalanges. | |
| Performance Data | Barb Pull-out, Thread Pull-out, Static/Fatigue Cantilever Bend, Insertion |
| Torque/Failure Torque, and Corrosion resistance testing were conduct to | |
| demonstrate that the Arthrex DynaNite PIP (Hammertoe) Implant performed | |
| statistically equivalent to the predicate device cleared under K960385. Barb | |
| Compression Force and Transformation Temperature tester were also conducted. |
Bacterial Endotoxins Test (BET) was performed on the Arthrex DynaNite PIP
(Hammertoe) Implant utilizing the Kinetic Chromogenic Method in accordance
with ANSI/AAMI ST72:2011/(R)2016, USP , USP , EP 2.6.14. Testing
was performed in compliance with US FDA good manufacturing practice (GMP)
regulations 21 CFR Parts 210, 211 and 820. The testing conducted demonstrates
that the Arthrex DynaNite PIP (Hammertoe) Implant meets pyrogen limit
specifications. |
| Conclusion | The Arthrex DynaNite PIP (Hammertoe) Implant is substantially equivalent to the
predicate devices in which the basic design features and intended uses are the
same. Any differences between the proposed device and the predicate devices
are considered minor and do not raise different questions of safety or
effectiveness.
Based on the indications for use, technological characteristics, and the summary
of data submitted, Arthrex Inc. has determined that the Arthrex DynaNite PIP
(Hammertoe) Implant is substantially equivalent to the currently marketed
predicate device. |