(160 days)
Not Found
No
The summary describes a mechanical bone fixation device made of Nitinol and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML.
Yes
The device is described as a bone fixation device intended for permanent implantation to provide fixation in various arthrodeses and osteotomies, which is a therapeutic purpose.
No
The device is a bone fixation device, specifically a surgical staple, used for permanently implanting to stabilize bones after osteotomies or arthrodeses. It is a treatment device, not a diagnostic one.
No
The device description clearly states it is a "Nickel Titanium (Nitinol) bone fixation device intended to be permanently implanted," which is a physical hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The Arthrex DynaNite Nitinol Staple is a bone fixation device intended to be permanently implanted in the body for surgical procedures on bones in the foot. It is used in vivo (within the living body), not in vitro (in a lab setting with specimens).
- Lack of IVD Characteristics: The description does not mention analyzing biological samples, using reagents, or providing diagnostic information based on laboratory tests.
Therefore, the Arthrex DynaNite Nitinol Staple is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Arthrex DynaNite Nitinol Staple is intended to be used for fixation such as: LisFranc arthrodesis, mono or bi-cortical osteotomies in the forefoot, first metatarsophalangeal arthrodesis, Akin osteotomy, midfoot and hindfoot arthrodeses or osteotomies, fixation of osteotomies for hallux valgus treatment (Scarf and Chevron), and arthrodesis of the metatarsocuneiform joint to reposition and stabilize metatarsus primus varus.
Product codes
JDR
Device Description
The Arthrex DynaNite Nitinol Staple is a Nickel Titanium (Nitinol) bone fixation device intended to be permanently implanted. The implant is formed with two legs connected by a bridge and is offered in multiple combinations of bridge widths, leg lengths, and cross sections to accommodate various anatomies.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
forefoot, midfoot, hindfoot
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)
To demonstrate product performance, Arthrex has conducted static four-point bending strength, pull-out strength, and fatigue resistance and compared the results to the predicate device. Corrosion and transformation temperature testing were also conducted.
Bacterial endotoxin per EP 2.6.14/USP was conducted to demonstrate that the device 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
§ 888.3030 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
December 13, 2017
Image /page/0/Picture/1 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Arthrex Inc. Rebecca R. Homan Regulatory Affairs Associate 1370 Creekside Boulevard Naples, Florida 34108-1945
Re: K172052
Trade/Device Name: Arthrex DynaNite Nitinol Staple Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: JDR Dated: October 18, 2017 Received: October 20, 2017
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. 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)
K172052
Device Name Arthrex DynaNite Nitinol Staple
Indications for Use (Describe)
The Arthrex DynaNite Nitinol Staple is intended to be used for fixation such as: LisFranc arthrodesis, mono or bi-cortical osteotomies in the forefoot, first metatarsophalangeal arthrodesis, Akin osteotomy, midfoot arthrodeses or osteotomies, fixation of osteotomies for hallux valgus treatment (Scarf and Chevron), and arthrodesis of the metatarsocuneiform joint to reposition and stabilize metatarsus primus varus.
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
| Date Prepared | June 30, 2017 |
|---|---|
| Submitter | Arthrex Inc. |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 | |
| Contact Person | Rebecca R. Homan |
| Regulatory Affairs Associate | |
| 1-239-643-5553, ext. 73429 | |
| rebecca.homan@arthrex.com | |
| Name of Device | Arthrex DynaNite Nitinol Staple |
| Common Name | Staple |
| Product Code | JDR |
| Classification Name | 21 CFR 888.3030: Single/multiple component metallic bone fixation appliances |
| and accessories | |
| Regulatory Class | II |
| Predicate Device | K043059: Wright Medical Technology Compression staple and simple staple |
| K153129: MX Orthopedics dynaMX Tabbed Staple | |
| K993714: BioMedical Enterprises, Inc. Memograph Staple | |
| Purpose of | |
| Submission | This Traditional 510(k) premarket notification is submitted to obtain clearance for |
| the Arthrex DynaNite Nitinol Staple. | |
| Device Description | The Arthrex DynaNite Nitinol Staple is a Nickel Titanium (Nitinol) bone fixation |
| device intended to be permanently implanted. The implant is formed with two | |
| legs connected by a bridge and is offered in multiple combinations of bridge | |
| widths, leg lengths, and cross sections to accommodate various anatomies. | |
| Indications for Use | The Arthrex DynaNite Nitinol Staple is intended to be used for fixation such as: |
| LisFranc arthrodesis, mono or bi-cortical osteotomies in the forefoot, first | |
| metatarsophalangeal arthrodesis, Akin osteotomy, midfoot and hindfoot | |
| arthrodeses or osteotomies, fixation of osteotomies for hallux valgus treatment | |
| (Scarf and Chevron), and arthrodesis of the metatarsocuneiform joint to | |
| reposition and stabilize metatarsus primus varus. | |
| Performance Data | To demonstrate product performance, Arthrex has conducted static four-point |
| bending strength, pull-out strength, and fatigue resistance and compared the | |
| results to the predicate device. Corrosion and transformation temperature | |
| testing were also conducted. | |
| Bacterial endotoxin per EP 2.6.14/USP was conducted to demonstrate that | |
| the device meets pyrogen limit specifications. | |
| Conclusion | The Arthrex DynaNite Nitinol Staple is substantially equivalent to the predicate |
| device in which the basic design features and intended uses are the same. Any | |
| differences between the proposed device and the predicate device are | |
| considered minor and do not raise questions concerning safety or effectiveness. | |
| Based on the indications for use, technological characteristics, and the summary | |
| of data submitted, Arthrex Inc. has determined that the proposed device is | |
| substantially equivalent to the currently marketed predicate device. |