(93 days)
Not Found
No
The description focuses on the mechanical properties and intended use of a physical screw, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is described as aiding in the "fixation and stabilization of the fractures and non-unions of small bones and small bone arthrodeses," indicating its use in treating and healing medical conditions.
No
This device is a compression screw used for fixation and stabilization of fractures and non-unions, which is a therapeutic function, not a diagnostic one.
No
The device description clearly describes a physical implantable screw made of titanium alloy, which is a hardware component, not software.
No, 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, tissue) to provide information about a person's health.
- Device Description: The DARCO Force Titanium Compression Screw is a surgical implant designed to fix and stabilize bones. It is used within the body, not to test samples outside the body.
- Intended Use: The intended use clearly describes a surgical procedure for bone fixation, not a diagnostic test.
The provided information describes a surgical implant, which falls under a different category of medical devices than IVDs.
N/A
Intended Use / Indications for Use
The DARCO Force Compression Screw is for fixation and stabilization of fractures and non-unions of small bones and small bone arthrodeses including but not limited to intra-articular fractures of the tarsals, metatarsals, carpals and metacarpals, bunionectomies and osteotomies, and arthredeses of small joints (e.g. phalanges).
The DARCO Force Titanium Compression Screw is to be used on indications that are common for currently marketed compression screws. The primary indication for use is the fixation and stabilization of the fractures and non-unions of small bones and small bone arthrodeses including but not limited to intra-articular fractures of the tarsals, metatarsal, carpals and metacarpals, bunionectomies and osteotomies, arthrodesis of small joints (e.g. phalanges).
Product codes
HWC
Device Description
The DARCO Force Compression Screw is a self drilling, self tapping and self counter sinking 3.2mm hex drive cannulated screw with a reverse cutting nib designed into the thread pattern. The cannulated feature allows for the use of a drill guide for precise placement while the smooth shank between the threaded portions of the screw allows the bone surfaces to be compressed to facilitate healing. The screws are made of Ti 6-Al 4-V biocompatible titanium alloy and coated with an anodized finish.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
small bones, tarsals, metatarsals, carpals, metacarpals, phalanges
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)
No clinical tests were used in the claim of substantial equivalence.
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.
0
Image /page/0/Picture/0 description: The image shows the word "DARCO" in a bold, sans-serif font. A plus sign is to the left of the word. The letters are all capitalized and black. A horizontal line is underneath the word.
Submitter Data:
810 Memorial Boulevard Huntington, WV 25701
Telephone: (304) 522-4883 Toll Free: (800) 999-8866 Telefax: (304) 522-0037
510(k) Summary
Darco International, Inc.
810 Memorial Blvd. Huntington WV 25701 Phone - (304) 522-4883 OCT 2 5 2006 Fax - (304) 522-0037 Mark S. Cooper Contact: July 21, 2006 Date: DARCO Force Compression Screw Device Name: Bone Screw Common Name: Smooth or threaded metallic bone fixation fastener Classification Name: (21 CFR 888.3040) Legally Marketed O.M.T. Scarf Screw (K042079) Predicate Device: Device Description: The DARCO Force Compression Screw is a self drilling, self tapping and self counter sinking 3.2mm hex drive cannulated screw with a reverse cutting nib designed into the thread pattern. The cannulated feature allows for the use of a drill guide for precise placement while the smooth shank between the threaded portions of the screw allows the bone surfaces to be compressed to facilitate healing. The screws are made of Ti 6-Al 4-V biocompatible titanium alloy and coated with an anodized finish. Intended Use: The DARCO Force Compression Screw is for fixation and stabilization of fractures and non-unions of small bones and small bone arthrodeses including but not limited to intra-articular fractures of the tarsals, metatarsals, carpals and metacarpals, bunionectomies and osteotomies, and arthredeses of small joints (e.g. phalanges). Technological Characteristics: The DARCO Force compression screw is designed with a self counter sinking and reverse cutting feature which the predicate device does not have. The DARCO screw is anodized while the predicate device has a CERID coating. These differences do not alter the safety, effectiveness, or intended use of the proposed device. Performance Data: No clinical tests were used in the claim of substantial equivalence.
8.1
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 5 2006
Darco International, Inc. % Mr. Mark S. Cooper Director of Regulatory Affairs 810 Memorial Boulevard Huntington, West Virginia 25701
Re: K062103
Trade/Device Name: DARCO Force Compression Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: October 19, 2006 Received: October 20, 2006
Dear Mr. Cooper:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
Page 2 - Mr. Mark S. Cooper
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Barbara Buchund
Mark N. Me. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Statement of Indications for Use
| 510(k) number (if known) | K062103 |
|---|---|
| Device Name | DARCO Force Compression Screw |
| Indications for Use | The DARCO Force Titanium Compression Screw is |
| to be used on indications that are common for | |
| currently marketed compression screws. The | |
| primary indication for use is the fixation and | |
| stabilization of the fractures and non-unions of | |
| small bones and small bone arthrodeses including | |
| but not limited to intra-articular fractures of the | |
| tarsals, metatarsal, carpals and metacarpals, | |
| bunionectomies and osteotomies, arthrodesis of | |
| small joints (e.g. phalanges). | |
| Prescription Use | |
| XXX | |
| (Part 21 CFR 801 Subpart D) | AND/OR |
| Over the Counter Use | |
| Part 21 CFR 807 Subpart C) |
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
Вавшала Василид for мкм
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K042103