SYNTHES 1.0MM TI. CORTEX, SELF-DRILLING SCREWS (HAND & NEURO)

K050607 · Synthes (Usa) · HRS · Apr 11, 2005 · Orthopedic

Device Facts

• Record ID: K050607
• Device Name: SYNTHES 1.0MM TI. CORTEX, SELF-DRILLING SCREWS (HAND & NEURO)
• Applicant: Synthes (Usa)
• Product Code: HRS · Orthopedic
• Decision Date: Apr 11, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Synthes 1.0mm Ti. Cortex, Self-drilling screws are intended for fracture fixation in hand surgery and neurosurgery.

Device Story

Self-drilling titanium bone screws; 1.0mm diameter; flat head profile with rounded edges; cruciform recess; lengths 2-4mm. Used for fracture fixation in hand and neurosurgery. Implanted by surgeons to stabilize bone fragments. Device provides mechanical fixation.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Titanium alloy; self-drilling; 1.0mm diameter; 2-4mm lengths; flat head profile; cruciform recess; mechanical bone fixation fastener.

Indications for Use

Indicated for fracture fixation in hand surgery and neurosurgery.

Regulatory Classification

Identification

Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

• Synthes 1.0 / 1.2 mm Plusdrive Screws
• KLS Martin 1.0mm System Center-Drive Screw System

Submission Summary (Full Text)

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KOSO607

| 510(k) Summary | Page 1 of 1 |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sponsor: | Synthes (USA)<br>1302 Wrights Lane East<br>West Chester, PA 19380<br>[phone] |
| Device Name: | Synthes 1.0mm Ti. Cortex, Self-drilling Screws (Hand & Neuro) |
| Classification: | 21 CFR 888.3040: Smooth or Threaded Metallic Bone Fixation<br>Fastener |
| Predicate Device: | Synthes 1.0 / 1.2 mm Plusdrive Screws<br>KLS Martin 1.0mm System Center-Drive Screw System |
| Device Description: | The 1.0mm Ti. Cortex Screws are self-drilling, have a flat head<br>profile with rounded edges with a cruciform recess, and are<br>available in lengths from 2 -- 4 mm. |
| Intended Use: | The Synthes 1.0mm Ti. Cortex, Self-drilling screws are intended<br>for fracture fixation in hand surgery and neurosurgery. |
| Substantial<br>Equivalence: | Documentation is provided which demonstrates that the Synthes<br>1.0mm Ti. Cortex Screws are substantially equivalent to other<br>legally marketed devices.<br><br>The term "substantial equivalence" as used in this 510(k)<br>notification is limited to the definition of substantial equivalence<br>found in the Federal Food, Drug and Cosmetic Act, as amended<br>and as applied under 21CFR 807, Subpart E under which a device<br>can be marketed without premarket approval or reclassification. A<br>determination of substantial equivalency under this notification is<br>not intended to have any bearing whatsoever on the resolution of<br>patent infringement suits or any other patent matters. No<br>statements related to, or in support of substantial equivalence<br>herein shall be construed as an admission against interest under the<br>US Patent Laws or their application by the courts. |

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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 stylized eagle with three lines representing its wings. The eagle is enclosed in a circle with the text "U.S. Department of Health and Human Services" written around the perimeter of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 1 2005

Ms. Kathy Anderson Regulatory Affairs Manager Synthes (USA) 1302 Wrights Lane East West Chester, Pennsylvania

Re: K050607

Trade/Device Name: Synthes (USA) 1.0mm Ti Cortex, Self-drilling Screws Regulation Numbers: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HRS Dated: March 09, 2005 Received: March 10, 2005

Dear Ms. Anderson:

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.

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Page 2 - Ms. Kathy Anderson

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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Stypk Plurde

Image /page/2/Picture/5 description: The image shows a close-up, hand-drawn illustration of what appears to be a plant stem or branch. The stem is depicted with a slightly curved shape and has a few small, pointed leaves or buds emerging from its sides. The drawing style is simple, with clear lines and minimal shading, giving it a somewhat technical or botanical illustration feel.

Miriam 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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Indications for Use

510(k) Number (if known):

Device Name: Synthes (USA) 1.0mm Ti. Cortex, Self-drilling Screws

Indications for Use:

The Synthes 1.0mm Ti. Cortex, Self-drilling screws are intended for fracture fixation in hand surgery and neurosurgery.

X Prescription Use (Per 21 CFR 801.109)

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)

Hypt. Elurke

(Division Sign-Off) Division of General, Restorative. and Neurological Devices

510(k) Number_________________________________________________________________________________________________________________________________________________________________