MERETE TWISTCUT SNAP-OFF BONE SCREW

K051323 · Merete Medical GmbH · HWC · Jul 7, 2005 · Orthopedic

Device Facts

• Record ID: K051323
• Device Name: MERETE TWISTCUT SNAP-OFF BONE SCREW
• Applicant: Merete Medical GmbH
• Product Code: HWC · Orthopedic
• Decision Date: Jul 7, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

Merete TwistCut™ Snap-Off Bone Screw is a metallic internal fixation device; self-drilling and self-tapping; 2.0 mm diameter; 11 to 14 mm length. Device consists of a screw with a flat thin head integrated with a short round shaft. During surgery, the shaft is attached to standard surgical power equipment; the shaft automatically separates from the screw head upon contact with cortical bone. Used by surgeons for bone fixation or reconstruction in the foot and hand. Benefits include stable fixation of small bone fragments and osteotomies.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Material: Titanium alloy Ti-6Al-4V ELI per ASTM F-136 and ISO 5832/3. Design: Self-drilling, self-tapping screw with integrated snap-off shaft. Dimensions: 2.0 mm diameter, 11-14 mm length. Energy source: External surgical power equipment. Sterilization: Not specified.

Indications for Use

Indicated for fixation of bone fractures or bone reconstruction in the foot and hand, including small bone fragments, Weil-osteotomy, and mono-cortical fixation.

Regulatory Classification

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.

Predicate Devices

• Landos TWIST-OFF™ Screw (K971069)
• New Deal SPIN® SNAP-OFF Screw (K011946)

Submission Summary (Full Text)

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## KOS 1323 4. Summary of Safety and Effectiveness Information

JUL 7 - 2005

| JUL 7 - 2005 | |
|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitted by: | Merete Medical GmbH<br>Alt Lankwitz 102, 12247 Berlin<br>Germany |
| FDA Registration Number: | 3002949614 |
| Contact Person: | Jenik Radon,<br>269 West Seventy-First Street<br>New York, N.Y. 10023<br>Tel. [phone]<br>Fax [phone] |
| Trade/Device Name: | Merete TwistCut™ Snap-Off Bone Screw |
| Device Classification: | 21 CFR 888.3040<br>Smooth or threaded Metallic bone fixation fastener |
| Proposed Regulatory Class: | Class II |
| Product Code: | HWC |
| Predicate Devices: | Landos TWIST-OFF™ Screw (K971069)<br>New Deal SPIN® SNAP-OFF Screw (K011946) |
| Description of Device: | The Merete TwistCut™ Snap-Off Bone Screw is made of<br>Titanium alloy ASTM F136(Ti-6Al-4V ELI), is self drilling and self<br>tapping and consists of a screw with a flat thin head which is<br>integrated with a short round shaft. The shaft is fixed on a<br>standard surgical power equipment. The shaft separates from<br>the screw when the head meets cortical bone. The screw is<br>2.0 mm in diameter and 11 to 14 mm in length. |
| Intended use: | The Merete TwistCut™ Snap-Off Bone Screw is indicated for<br>fixation of bone fractures or for bone reconstruction. Examples<br>include: Fixation of Small Bone Fragments, Weil-Osteotomy,<br>Mono-Cortical Fixation, Osteotomies and fractures fixation in<br>the foot and hand. |
| Technological Characteristics: | The Merete TwistCut™ Snap-Off bone screws are similar to<br>legally marketed predicate devices listed above in that they<br>share similar indications for use, are manufactured from similar<br>materials and incorporate similar technological characteristics. |
| Potential Risks: | The risks associated with this device are the same as with any<br>metallic internal fixation device. These include but not limited to<br>the following: Delayed or nonunion which may lead to breakage<br>of the implant. Bending or fracture of the implant. Metal<br>sensitivity, or allergic reaction to a foreign body. Pain,<br>discomfort, or abnormal sensation due to the presence of the<br>device. |

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## 5. Standards

KC051123 P4/2

- 1) The Merete TwistCut™ screws are produced from titanium alloy Ti-6Al-4V according to ASTM F-136 and ISO 5832/3.

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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.

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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 [phone] . 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 [phone] 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

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3. Indications for Use of Merete TwistCut™ Snap-Off Bone Screw

## Indications for Use

Merete TwistCut™ Snap-Off Bone Screw

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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) | |
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| | <center> <img alt="Signature" src="signature.png"/> </center> |
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| Division of General, Restorative, | |
|-----------------------------------|--|
| and Neurological Devices | |

KOS1323 510(k) Number_