(44 days)
No
The summary describes a standard bone screw made of titanium alloy for fracture fixation, with no mention of AI or ML technology in its intended use, device description, or any other section.
Yes
The device is described as a bone fixation screw used for small bone fracture fixation and stabilization of bones of the feet, which directly falls under a therapeutic purpose.
No.
The device is a bone screw used for fracture fixation and stabilization, which makes it a therapeutic device rather than a diagnostic one. Its intended use is to treat existing conditions, not to identify or diagnose them.
No
The device description clearly states it is a "fully or partially threaded cannulated bone fixation screw" made of titanium alloy, which is a physical hardware component.
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 for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The provided information clearly describes a surgical implant used for fixing and stabilizing bones during surgery. It is a physical device inserted into the body, not a test performed on a sample outside the body.
The description focuses on the device's material, size, and how it is used in surgical procedures on the bones of the feet. This is characteristic of a surgical device, not an IVD.
N/A
Intended Use / Indications for Use
Small bone fracture fixation. Fixation and stabilization of bones of the feet in case of a osteotomy or fusion, such as Scarf-Osteotomy, Chevron-Austin Osteotomy, Akin-Osteotomy, Closing wedge osteotomy, MPG-Arthrodesis as well as for the fixation of almost all common osteotomies of the first metatarsal.
Product codes
HWC
Device Description
The DuoThread™ Bone screw is a fully or partially threaded cannulated bone fixation screw with a threaded head. The screw is made of titanium alloy (Ti-6Al-4V) ASTM F-136 in 3 mm diameter and in lengths 10 mm to 34 mm (in 2 mm increments).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bones of the feet, first metatarsal
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Landos Scarf Thread-Head™ Head Screw(K971070), Zimmer Herbert Bone Screw (K792022)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
4. Summary of Safety and Effectiveness Information
MAY 27 2005
| Submitted by: | Merete Medical GmbH
Alt Lankwitz 102, 12247 Berlin
Germany | | |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| FDA Registration Number: | 3002949614 | | |
| Contact Person: | Jenik Radon,
269 West Seventy-First Street
New York, N.Y. 10023
Tel. 212- 496-2700 Fax 212- 724-3393 | | |
| Trade/Device Name: | Merete DuoThread™ Bone Screw | | |
| Device Classification: | 21 CFR 888.3040
Smooth or threaded Metallic bone fixation fastener | | |
| Proposed Regulatory Class: | Class II | | |
| Product Code: | HWC | | |
| Predicate Devices: | Landos Scarf Thread-Head™ Head Screw(K971070)
Zimmer Herbert Bone Screw (K792022) | | |
| Description of Device: | The DuoThread™ Bone screw is a fully or partially threaded
cannulated bone fixation screw with a threaded head. The screw
is made of titanium alloy (Ti-6Al-4V) ASTM F-136 in 3 mm
diameter and in lengths 10 mm to 34 mm (in 2 mm increments). | | |
| Intended use: | Small bone fracture fixation. Fixation and stabilization of bones
of the feet in case of an osteotomy or fusion such as Scarf
Osteotomy, Chevron-Austin osteotomy, Akin-osteotomy, Closing
wedge osteotomy. MPG-Athrodesis as well as for the fixation of
almost all common osteotomies of the first metatarsal. | | |
| Technological Characteristics: | The DuoThread™ bone screws are similar to legally marketed
predicate devices listed above in that they share similar
indications for use, are manufactured from similar materials and
incorporate similar technological characteristics. | | |
| Potential Risks: | The risks associated with this device are the same as with any
metallic internal fixation device. These include but not limited to
the following: Delayed or nonunion which may lead to breakage
of the implant. Bending or fracture of the implant. Metal
sensitivity, or allergic reaction to a foreign body. Pain,
discomfort, or abnormal sensation due to the presence of the
device. | | |
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of the human form.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 7 2005
Merete Medical GmbH C/o Mr. Jenik Radon 269 West Seventy-First Street New York, New York 10023
Re: K050924
Trade/Device Name: DuoThread™ Bone Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: April 13, 2005 Received: April 13, 2005
Dear Mr. Radon:
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. Jenik Radon
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 premated 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Stupt Clurde
Miriam C. Provost, Ph.D
Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
3. Indications for Use DuoThread™ Bone Screw
Indications for Use DuoThread™ Bone Screw
510 (k) Number : K050924
Device Name: DuoThread™ Bone Screw
Indications For Use:
Small bone fracture fixation. Fixation and stabilization of bones of the feet in case of a osteotomy or fusion, such as Scarf-Osteotomy, Chevron-Austin Osteotomy, Akin-Osteotomy, Closing wedge osteotomy, MPG-Arthrodesis as well as for the fixation of almost all common osteotomies of the first metatarsal.
| Prescription Use | X | AND/OR | Over-The-Counter Use | |
|---|---|---|---|---|
| (Part 21 CFR 801 Subpart D) | (21 CFR 807 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IN NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
| Page 1 of 1 | |
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Division of General, Restorative,
| Merete Medical GmbH | and Neurological Devices | Page 4 of 24 |
|---|---|---|
| --------------------- | -------------------------- | -------------- |
| 510(k) Number | 5050924 |
|---|---|
| --------------- | --------- |