(190 days)
The DART-FIRE EDGE Cannulated Screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of foot and ankle bones appropriate for the device. Screws gre intended for single use only.
The DART-FIRE EDGE Cannulated Screw System contains partially and fully threaded, cannulated screws offered in a variety of diameters and lengths. The screws are manufactured from titanium alloy (ASTM F136).
Here's a summary of the acceptance criteria and study information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion (Type of Test) | Reported Device Performance |
|---|---|
| Insertion Torque | Demonstrated substantial equivalence to predicate device |
| Removal Torque | Demonstrated substantial equivalence to predicate device |
| Pull Out Strength | Demonstrated substantial equivalence to predicate device |
| Ultimate Torque | Demonstrated substantial equivalence to predicate device |
| Yield Torque Strength (per ASTM F543) | Demonstrated substantial equivalence to predicate device |
| RF Heating (per ASTM F2182 for MR Safety) | Demonstrated substantial equivalence to predicate device |
| Image Artifact (per ASTM F2182 for MR Safety) | Demonstrated substantial equivalence to predicate device |
| Induced Force (per ASTM F2052 for MR Safety) | Demonstrated substantial equivalence to predicate device |
| Induced Torques (per ASTM F2052 for MR Safety) | Demonstrated substantial equivalence to predicate device |
2. Sample Size for Test Set and Data Provenance
Not applicable. The study was non-clinical and involved performance testing of the device itself rather than a test set of data.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. This was a non-clinical study based on engineering performance tests.
4. Adjudication Method for Test Set
Not applicable. There was no test set requiring expert adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This was a non-clinical study for a bone fixation device, not an AI-assisted diagnostic tool.
6. Standalone (Algorithm Only) Performance
Not applicable. This device is a physical medical implant, not an algorithm. The performance described is for the device's physical properties.
7. Type of Ground Truth Used
The ground truth or benchmark for performance was the performance of the legally marketed predicate device (K082320: Wright Compression Screws, K080850: DARCO Headless Compression Screw, K183696: PERFORM Reverse). The study aimed to demonstrate "substantial equivalence" to these devices through various mechanical and MR Safety tests.
8. Sample Size for Training Set
Not applicable. This was a non-clinical study for a physical device, not an AI model.
9. How Ground Truth for Training Set Was Established
Not applicable. There was no training set in the context of this device.
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Wright Medical Michael Mullins SR Regulatory Affairs Specialist 1023 Cherry Road Memphis, Tennessee 38117
Re: K203228
Trade/Device Name: DART-FIRE EDGE Cannulated Screw System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: April 9, 2021 Received: April 12, 2021
Dear Michael Mullins:
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.
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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K203228
Device Name DART-FIRE EDGE Cannulated Screw System
Indications for Use (Describe)
The DART-FIRE EDGE Cannulated Screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of foot and ankle bones appropriate for the device. Screws gre intended for single use only.
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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K203228 Page 1 of 2
1023 Cherry Road Memphis, TN 38117 USA
901 867 9971 800 238 7117 wright.com
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510(K) SUMMARY
In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807.92, this information serves as a Summary of Safety and Effectiveness for the use of the DART-FIRE EDGE Cannulated Screw System.
| (a)(1). Submitted By: | Wright Medical Technology, Inc.1023 Cherry RoadMemphis, TN 38117 |
|---|---|
| Date: | October 30, 2020 |
| Contact Person: | Michael MullinsRegulatory Affairs SpecialistPhone - (901) 867-4142Fax - (901) 867-4190 |
| (a)(2). Proprietary Name: | DART-FIRE EDGE Cannulated Screw System |
| Common Name: | Bone Screw |
| Classification Name and Regulation: | Smooth or threaded metallic bone fixationfastener, 21 CFR 888.3040 – Class II |
| Device Product Code, Device Panel: | HWC - Orthopedic |
| (a)(3). Predicate Device: | K082320: Wright Compression Screws(primary)K080850: DARCO Headless CompressionScrew (reference)K183696: PERFORM Reverse (reference) |
(a)(4). Device Description
The DART-FIRE EDGE Cannulated Screw System contains partially and fully threaded, cannulated screws offered in a variety of diameters and lengths. The screws are manufactured from titanium alloy (ASTM F136).
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(a)(5). INTENDED USE
The DART-FIRE EDGE Cannulated Screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of foot and ankle bones appropriate for the size of the device. Screws are intended for single use only.
(a)(6). Technological Characteristics Comparison
The DART-FIRE EDGE Screw System is a new screw system. Compared to the legally marketed primary predicate, the subject system has identical indications, similar design features, the same sterilization method, and similar performance characteristics.
(b)(1). Substantial Equivalence - Non-Clinical Evidence
Performance testing and analysis demonstrated substantial equivalence to the predicate device in insertion torque, removal torque, pull out, ultimate torque, yield torque strength per ASTM F543 and simulated MR Safety testing per ASTM F2182 (RF Heating/Image Artifact) and ASTM F2052 (Induced Force/Torques).
(b)(2). Substantial Equivalence - Clinical Evidence
N/A
(b)(3). Substantial Equivalence - Conclusions
The design characteristics of the subject system do not raise any new types of questions of safety or effectiveness. From the evidence submitted in this 510(k), the subject devices can be expected to perform at least as well as the predicate 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.