SYNTHES (USA) 3.5MM CONICAL SCREWS

K050683 · Synthes (Usa) · HWC · Apr 27, 2005 · Orthopedic

Device Facts

• Record ID: K050683
• Device Name: SYNTHES (USA) 3.5MM CONICAL SCREWS
• Applicant: Synthes (Usa)
• Product Code: HWC · Orthopedic
• Decision Date: Apr 27, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Synthes 3.5 mm Conical Screws are intended to be used with existing Synthes LCP plating systems for fixation and interfragmentary compression of various bones, such as the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia and fibula, particularly in osteopenic bone.

Device Story

Synthes 3.5mm Conical Screws are orthopedic bone fixation fasteners; designed for use with existing Synthes LCP plating systems. Features include self-tapping threads and stardrive or hex drive recesses. Manufactured from stainless steel or titanium. Available in lengths 40-95 mm. Used by surgeons in clinical settings for bone fracture fixation and interfragmentary compression, particularly in osteopenic bone. Device provides mechanical stability to bone fragments to facilitate healing.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and material characteristics.

Technological Characteristics

Materials: Stainless steel and titanium. Design: Self-tapping, conical screw, 3.5mm diameter, 40-95mm length. Drive: Stardrive or hex recess. Function: Bone fixation fastener for use with LCP plating systems.

Indications for Use

Indicated for fixation and interfragmentary compression of bones including clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia, and fibula, specifically for patients with osteopenic bone.

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

• Synthes 3.5 mm Locking Screws

Submission Summary (Full Text)

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K050683

| 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 3.5mm Conical Screws |
| Classification: | 21 CFR 888.3040: Smooth or Threaded Metallic Bone Fixation<br>Fastener. |
| Predicate Devices: | Synthes 3.5 mm Locking Screws |
| Device Description: | The 3.5 mm conical screws are self-tapping, have a stardrive or hex<br>drive recess, and are manufactured from stainless steel and<br>titanium. The 3.5 mm conical screws are available in various<br>lengths ranging from 40-95 mm. |
| Intended Use: | The Synthes 3.5 mm Conical Screws are intended to be used with<br>existing Synthes LCP plating systems for fixation and<br>interfragmentary compression of various bones, such as the<br>clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia and<br>fibula, particularly in osteopenic bone. |
| Substantial<br>Equivalence: | Information presented supports substantial equivalence. |

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Public Health Service

APR 2 7 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Kathy Anderson Regulatory Affairs Manager Synthes (USA) 1302 Wrights Lane East West Chester, Pennsylvania 19380

Re: K050683

Trade/Device Name: Synthes (USA) 3.5mm Conical Screws Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: March 16, 2005 Received: March 17, 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,

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

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Indications for Use

510(k) Number (if known):

Device Name:

Synthes (USA) 3.5 mm Conical Screws

Indications for Use:

The Synthes 3.5 mm Conical Screws are intended to be used with existing Synthes LCP plating systems for fixation and interfragmentary compression of various bones, such as the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia and fibula, particularly in osteopenic bone.

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)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

K050683