(136 days)
Not Found
No
My reasoning is that the provided text describes a physical screw system for bone fixation and does not mention any software, algorithms, or AI-related components.
Yes.
The device facilitates bone reconstruction, fracture repair, and joint fusion, which are therapeutic actions aimed at treating medical conditions.
No
The device is a system of screws and instruments used for bone reconstruction, fracture repair, and fusion, which are therapeutic and restorative functions, not diagnostic.
No
The device is a system of physical hardware components, including screws, wires, and surgical instruments, designed for bone fixation and repair. The description clearly details the materials, sizes, and functions of these tangible components, and there is no mention of any software aspect.
No.
The device is a bone fixation system, which is an implantable medical device, not a diagnostic test performed on human samples.
N/A
Intended Use / Indications for Use
The EleganzTM Fusion Screw System is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device. Examples include scaphoid and other carpal fractures, metacarpal and phalangeal fusions, and bunionectomies.
The screws are not intended for interference or soft tissue fixation.
Product codes (comma separated list FDA assigned to the subject device)
HWC
Device Description
The EleganzTM Fusion Screw System includes screws for bone fixation and a set of instruments used for screw site preparation and delivery. The device is offered in two non-sterile trays that contain the screw, Kirschner wire, bone preparation instrumentation and a driver.
The screws and Kirschner wires are used to stabilize a fracture, osteotomy site, or joint so that healing and fusion may occur which achieves its intended function.
The screws are available in solid and cannulated versions and are made from Ti6Al4V alloy. They range from 8-50 mm in length. The outer diameter is tapered, varying from 2.5 mm at the tail to 2.0 mm (solid) or 2.25 mm (cannulated) at the tip. The Kirschner wires are 316 stainless steel.
The instrumentation includes a drill, driver handle, driver bit, depth gauge / countersink, Kirschner wire, and ball and socket reamers. The drills and driver components are cannulated. The drills are offered in two lengths. The driver handle is used with the driver bit to insert the screw as well as with the drill for hand drilling. The depth gauge measures the Kirschner wire to determine its depth in the bone. The countersink has cutting flutes for easier entry into the intramedullary canal. The ball and socket reamers create a spherical radius on joint surfaces for better bony fusion.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bones appropriate for the size of the device. Examples include scaphoid and other carpal fractures, metacarpal and phalangeal fusions, and bunionectomies.
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)
Non-clinical testing was conducted in accordance with ASTM F543-17 (Standard Specification and Test Methods for Metallic Medical Bone Screws), FDA Guidance Orthopedic Non-Spinal Metallic Bone Screws and Washers - Performance Criteria for Safety and Performance Based Pathway, and in comparison to screws cleared under the predicate devices.
No clinical tests were submitted, referenced or relied for the 510(k).
Based on the indications for use, technological characteristics, and the summary of data submitted, Dev4 has determined that the subject device does not raise different questions of safety and effectiveness compared to the predicate devices. Therefore, the proposed subject device is substantially equivalent to the legally marketed predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
FDA 510(k) Clearance Letter - Eleganz Fusion Screw System
Page 1
June 13, 2025
Dev4
Lance Terrill
CTO
1002 Gemini Street, Suite 129
Houston, Texas 77058
Re: K250251
Trade/Device Name: Eleganz Fusion Screw System (Fusion 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: January 24, 2025
Received: January 28, 2025
Dear Lance Terrill:
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 (the 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 available 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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K250251 - Lance Terrill Page 2
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-
Page 3
K250251 - Lance Terrill Page 3
assistance/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 -S
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
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
Indications for Use
Submission Number (if known)
K250251
Device Name
Eleganz Fusion Screw System (Fusion Screw System)
Indications for Use (Describe)
The Eleganz™ Fusion Screw System is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device. Examples include scaphoid and other carpal fractures, metacarpal and phalangeal fusions, and bunionectomies.
The screws are not intended for interference or soft tissue fixation.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Page 5
510(k) Summary
510(k)#: K250251
Prepared on: 2025-06-12
Contact Details
21 CFR 807.92(a)(1)
| Field | Value |
|---|---|
| Applicant Name | Dev4 |
| Applicant Address | 1002 Gemini Street, Suite 129 Houston TX 77058 United States |
| Applicant Contact Telephone | (832) 257-0845 |
| Applicant Contact | Mr. Jeff Seavey |
| Applicant Contact Email | jeff@dev-4.com |
| Correspondent Name | Dev4 |
| Correspondent Address | 1002 Gemini Street, Suite 129 Houston TX 77058 United States |
| Correspondent Contact Telephone | (346) 831-9899 |
| Correspondent Contact | Mr. Lance Terrill |
| Correspondent Contact Email | lance@dev-4.com |
Device Name
21 CFR 807.92(a)(2)
| Field | Value |
|---|---|
| Device Trade Name | Eleganz Fusion Screw System (Fusion Screw System) |
| Common Name | Smooth or threaded metallic bone fixation fastener |
| Classification Name | Screw, Fixation, Bone |
| Regulation Number | 888.3040 |
| Product Code(s) | HWC |
Legally Marketed Predicate Devices
21 CFR 807.92(a)(3)
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
|---|---|---|
| K230744 | Acutrak 3 Headless Compression Screw System | HWC |
| K190324 | Cannulated Screw System | HWC |
| K131620 | Jones FX System | HWC |
Device Description Summary
21 CFR 807.92(a)(4)
The EleganzTM Fusion Screw System includes screws for bone fixation and a set of instruments used for screw site preparation and delivery. The device is offered in two non-sterile trays that contain the screw, Kirschner wire, bone preparation instrumentation and a driver.
The screws and Kirschner wires are used to stabilize a fracture, osteotomy site, or joint so that healing and fusion may occur which achieves its intended function.
Page 1 of 2
Page 6
The screws are available in solid and cannulated versions and are made from Ti6Al4V alloy. They range from 8-50 mm in length. The outer diameter is tapered, varying from 2.5 mm at the tail to 2.0 mm (solid) or 2.25 mm (cannulated) at the tip. The Kirschner wires are 316 stainless steel.
The instrumentation includes a drill, driver handle, driver bit, depth gauge / countersink, Kirschner wire, and ball and socket reamers. The drills and driver components are cannulated. The drills are offered in two lengths. The driver handle is used with the driver bit to insert the screw as well as with the drill for hand drilling. The depth gauge measures the Kirschner wire to determine its depth in the bone. The countersink has cutting flutes for easier entry into the intramedullary canal. The ball and socket reamers create a spherical radius on joint surfaces for better bony fusion.
Intended Use/Indications for Use
21 CFR 807.92(a)(5)
The Eleganz™ Fusion Screw System is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device. Examples include scaphoid and other carpal fractures, metacarpal and phalangeal fusions, and bunionectomies.
The screws are not intended for interference or soft tissue fixation.
Indications for Use Comparison
21 CFR 807.92(a)(5)
The Indications For Use for the Eleganz Fusion Screw System device is the same as the primary predicate - Acutrak Fusion Screw System and similar to the secondary predicate - Cannulated Screw System.
Technological Comparison
21 CFR 807.92(a)(6)
The Dev4 Eleganz screw implants have similar technological characteristics in design, material, principle of operation as the Acutrak 3 and the Cannulated Screw predicate devices.
Non-Clinical and/or Clinical Tests Summary & Conclusions
21 CFR 807.92(b)
Non-clinical testing was conducted in accordance with ASTM F543-17 (Standard Specification and Test Methods for Metallic Medical Bone Screws), FDA Guidance Orthopedic Non-Spinal Metallic Bone Screws and Washers - Performance Criteria for Safety and Performance Based Pathway, and in comparison to screws cleared under the predicate devices.
No clinical tests were submitted, referenced or relied for the 510(k).
Based on the indications for use, technological characteristics, and the summary of data submitted, Dev4 has determined that the subject device does not raise different questions of safety and effectiveness compared to the predicate devices. Therefore, the proposed subject device is substantially equivalent to the legally marketed predicate devices.
Page 2 of 2