(81 days)
The Arthrex DynaNite® PIP (Hammertoe) Implant is intended to stabilize and aid in the fixation of fractures, fusions, and osteotomies of the phalanges.
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.
This document is a 510(k) premarket notification for the Arthrex DynaNite® PIP (Hammertoe) Implant. It is a Class II medical device for bone fixation. Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Barb Pull-out | Statistically equivalent to predicate device K960385 | Performed statistically equivalent to predicate device K960385 |
| Thread Pull-out | Statistically equivalent to predicate device K960385 | Performed statistically equivalent to predicate device K960385 |
| Static/Fatigue Cantilever Bend | Statistically equivalent to predicate device K960385 | Performed statistically equivalent to predicate device K960385 |
| Insertion Torque/Failure Torque | Statistically equivalent to predicate device K960385 | Performed statistically equivalent to predicate device K960385 |
| Corrosion Resistance | Statistically equivalent to predicate device K960385 | Performed statistically equivalent to predicate device K960385 |
| Barb Compression Force | Not explicitly stated as a comparative acceptance criterion, but tested. | Data not provided in this summary. |
| Transformation Temperature | Not explicitly stated as a comparative acceptance criterion, but tested. | Data not provided in this summary. |
| Bacterial Endotoxins Test (BET) | Meets pyrogen limit specifications as per ANSI/AAMI ST72:2011/(R)2016, USP <161>, USP <85>, EP 2.6.14. | Meets pyrogen limit specifications. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for each specific test (Barb Pull-out, Thread Pull-out, etc.). It only mentions that "testing was conducted to demonstrate that the Arthrex DynaNite PIP (Hammertoe) Implant performed statistically equivalent to the predicate device cleared under K960385."
The provenance of the data is not specified in terms of country of origin or whether it was retrospective or prospective. It is implied to be data generated in support of this 510(k) submission, likely from laboratory testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable. The device performance tests described (mechanical and biological) are laboratory-based, objective measurements, not subjective evaluations requiring expert interpretation of a "ground truth" like in a diagnostic AI study.
4. Adjudication Method for the Test Set
This information is not applicable. As explained above, the tests are objective laboratory measurements, not assessments that require adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This document describes the performance of a physical medical implant through mechanical and biological testing. It is not an AI/software device that would typically undergo an MRMC comparative effectiveness study to assess human reader improvement.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No. This document concerns a physical implant, not an algorithm or software. Therefore, the concept of "standalone performance" for an algorithm is not applicable.
7. Type of Ground Truth Used
The "ground truth" for the mechanical performance tests are the objective measurements obtained from laboratory testing, which are then compared to the performance of the predicate device (K960385). For the Bacterial Endotoxins Test, the "ground truth" is adherence to established biological safety standards and regulations (ANSI/AAMI ST72:2011/(R)2016, USP <161>, USP <85>, EP 2.6.14).
8. Sample Size for the Training Set
This information is not applicable. There is no mention of a "training set" as this is a physical medical device and not an AI or machine learning model.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable, as there is no training set for a physical implant.
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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
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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 BoulevardNaples, FL 34108-1945 |
| Contact Person | Rebecca R. HomanSenior Regulatory Affairs Associate1-239-643-5553, ext. 73429rebecca.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 forthe 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 athreaded end and a barbed end. The implant will be offered in 12mm, 14mm and16 mm lengths, each available in straight and bent configurations. The implant isprovided 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 inthe fixation of fractures, fusions, and osteotomies of the phalanges. |
| Performance Data | Barb Pull-out, Thread Pull-out, Static/Fatigue Cantilever Bend, InsertionTorque/Failure Torque, and Corrosion resistance testing were conduct todemonstrate that the Arthrex DynaNite PIP (Hammertoe) Implant performedstatistically equivalent to the predicate device cleared under K960385. BarbCompression 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 accordancewith ANSI/AAMI ST72:2011/(R)2016, USP <161>, USP <85>, EP 2.6.14. Testingwas performed in compliance with US FDA good manufacturing practice (GMP)regulations 21 CFR Parts 210, 211 and 820. The testing conducted demonstratesthat the Arthrex DynaNite PIP (Hammertoe) Implant meets pyrogen limitspecifications. |
| Conclusion | The Arthrex DynaNite PIP (Hammertoe) Implant is substantially equivalent to thepredicate devices in which the basic design features and intended uses are thesame. Any differences between the proposed device and the predicate devicesare considered minor and do not raise different questions of safety oreffectiveness.Based on the indications for use, technological characteristics, and the summaryof data submitted, Arthrex Inc. has determined that the Arthrex DynaNite PIP(Hammertoe) Implant is substantially equivalent to the currently marketedpredicate device. |
§ 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.