(48 days)
Not Found
No
The device description focuses on the mechanical properties and function of a bone screw, with no mention of AI or ML capabilities. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
The device is a bone screw intended for the fixation of bone fractures or reconstruction, which is a surgical implant rather than a device used for therapy.
No
Explanation: The device description states that the Merete TwistCut™ Snap-Off Bone Screw is used for "fixation of bone fractures or for bone reconstruction," indicating that it is a treatment device, not a diagnostic one.
No
The device description clearly states it is a bone 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 perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The Merete TwistCut™ Snap-Off Bone Screw is a surgical implant designed for the mechanical fixation of bone fractures and reconstruction. It is physically inserted into the body.
- Intended Use: The intended use clearly states "fixation of bone fractures or for bone reconstruction," which is a surgical procedure, not a diagnostic test performed on a sample outside the body.
The description of the device and its intended use are consistent with a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Merete TwistCut™ Snap-Off Bone Screw is indicated for fixation of bone fractures or for bone reconstruction. Examples include: Fixation of Small Bone Fragments, Weil-Osteotomy, Mono-Cortical Fixation, Osteotomies and fractures fixation in the foot and hand.
Product codes
HWC
Device Description
The Merete TwistCut™ Snap-Off Bone Screw is made of Titanium alloy ASTM F136(Ti-6Al-4V ELI), is self drilling and self tapping and consists of a screw with a flat thin head which is integrated with a short round shaft. The shaft is fixed on a standard surgical power equipment. The shaft separates from the screw when the head meets cortical bone. The screw is 2.0 mm in diameter and 11 to 14 mm in length.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone, foot, hand
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)
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
KOS 1323 4. Summary of Safety and Effectiveness Information
JUL 7 - 2005
| JUL 7 - 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 TwistCut™ Snap-Off 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 TWIST-OFF™ Screw (K971069) |
| New Deal SPIN® SNAP-OFF Screw (K011946) | |
| Description of Device: | The Merete TwistCut™ Snap-Off Bone Screw is made of |
| Titanium alloy ASTM F136(Ti-6Al-4V ELI), is self drilling and self | |
| tapping and consists of a screw with a flat thin head which is | |
| integrated with a short round shaft. The shaft is fixed on a | |
| standard surgical power equipment. The shaft separates from | |
| the screw when the head meets cortical bone. The screw is | |
| 2.0 mm in diameter and 11 to 14 mm in length. | |
| Intended use: | The Merete TwistCut™ Snap-Off Bone Screw is indicated for |
| fixation of bone fractures or for bone reconstruction. Examples | |
| include: Fixation of Small Bone Fragments, Weil-Osteotomy, | |
| Mono-Cortical Fixation, Osteotomies and fractures fixation in | |
| the foot and hand. | |
| Technological Characteristics: | The Merete TwistCut™ Snap-Off 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
5. Standards
KC051123 P4/2
-
- The Merete TwistCut™ screws are produced from titanium alloy Ti-6Al-4V according to ASTM F-136 and ISO 5832/3.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes representing health, human services, and well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 7 - 2005
Merete Medical GmbH C/o Mr. Jenik Radon 269 West Seventy- First Street New York, New York 10023
Re: K051323
Trade/Device Name: Merete TwistCut™ Snap-Off Bone Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: May 18, 2005 Received: May 20, 2005
Dear Mr. Radon:
We have reviewed your Section 510(k) premarket notification of intent to market the device wt have teviewed your bected by the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 101 use stated in the encreate) to the enactment date of the Medical Device Amendments, or to commerce pror to rite) 2011-11-11 accordance with the provisions of the Federal Food, Drug, devices that have been require approval of a premarket approval application (PMA). and Costinetter rear (110.) that to device, subject to the general controls provisions of the Act. The r ou may, mereloro, manno of the Act include requirements for annual registration, listing of general controls provision 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 it may be subject to back af 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 r lease be action and a determination that your device complies with other requirements of the Act that I Drivies and regulations administered by other Federal agencies. You must or any it call the Act's requirements, including, but not limited to: registration and listing (21 Comply with an the Her 610 CFR Part 801); good manufacturing practice requirements as set CFR Part 807); adoling (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin marketing your antial equivalence of your device to a legally
premarket notification. The FDA finding of substantial equivale vour premarket nonification. The PDA miding of backanse of The Sun of 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
rs of the results of the count on 2010 - the receives not the regulation en If you desire specific advice for your de not on one on the regulation entitled.
contact the Office of Compliance at (240) 276-0120 . Also, please note the may abtain contact the Office of Compliance at (210) 276 of Pat 807.97). You may obtain
"Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain "Misbranding by reletence to premance notification in the Act from the Division of Small other general information on your responsion its toll-free number (800) 638-2041 or
Manufacturers, International and Consumer Assistance of Vivaners/spaner/jpday.html Manufacturers, International and Consumer Aborazios arovedablindustry/support/index.html.
Sincerely yours,
Stephen Rourke
iriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
- Indications for Use of Merete TwistCut™ Snap-Off Bone Screw
Indications for Use
Merete TwistCut™ Snap-Off Bone Screw
ﮩﺘﺤﻘﮧ،
510(k) Number (if known):
Device Name: Merete TwistCut™ Snap-Off Bone Screw
Indications For Use:
The Merete TwistCut™ Snap-Off Bone Screw is indicated for fixation of bone The Merele TwistOut - Onap on Bons Examples include: Fixation of Small
fractures or for bone reconstruction. Examples include: Ontactamian ond fractures of Tor Done Teconstration. Examples Fixation, Osteotomies and fractures fixation in the foot and hand.
| Prescription Use | X |
|---|---|
| (Part 21 CFR 801 Subpart D) |
AND/OR
| Over-The-Counter Use | |
|---|---|
| (21 CFR 807 Subpart C) |
(Please Do Not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| Page 1 of 1 | |
| (Division Sign-Off) |
| Division of General, Restorative, | |
|---|---|
| and Neurological Devices |
KOS1323 510(k) Number_