SYNTHES 3.5MM CORTEX SCREWS

K043185 · Synthes (Usa) · HWC · Feb 3, 2005 · Orthopedic

Device Facts

• Record ID: K043185
• Device Name: SYNTHES 3.5MM CORTEX SCREWS
• Applicant: Synthes (Usa)
• Product Code: HWC · Orthopedic
• Decision Date: Feb 3, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Synthes 3.5 mm Cortex Screws are intended for fixation of fractures, osteotomies and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia, calaneous, femur and fibula.

Device Story

Synthes 3.5 mm Cortex Screws are orthopedic bone fixation fasteners; self-tapping design with stardrive recess; manufactured from stainless steel or titanium. Used by surgeons in clinical settings for internal fixation of bone fractures, osteotomies, and non-unions across various anatomical sites including long bones and pelvis. Screws provide mechanical stabilization of bone segments to facilitate healing. Available in lengths from 10-150 mm.

Technological Characteristics

Materials: stainless steel and titanium. Design: self-tapping, stardrive recess. Dimensions: 3.5 mm diameter, 10-150 mm length. Mechanical bone fixation fastener.

Indications for Use

Indicated for fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia, calcaneus, femur, and fibula.

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 Cortex Screws

Submission Summary (Full Text)

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3.0

K 04/3/85

| 510(k) Summary | Page 1 of 1 |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sponsor: | Synthes (USA)<br>1690 Russell Road<br>Paoli, PA 19301<br>[phone] |
| Device Name: | Synthes 3.5mm Cortex Screws |
| Classification: | 21 CFR 888.3040: Smooth or Threaded Metallic Bone Fixation<br>Fastener. |
| Predicate Devices: | Synthes 3.5 mm Cortex Screws |
| Device Description: | The 3.5 mm cortex screws are self-tapping, have a stardrive recess,<br>and are manufactured from stainless steel and titanium. The self-<br>tapping screws are available in various lengths ranging from 10-<br>150 mm. |
| Intended Use: | The Synthes 3.5 mm Cortex Screws are intended for fixation of<br>fractures, osteotomies and non-unions of the clavicle, scapula,<br>olecranon, humerus, radius, ulna, pelvis, tibia, calaneous, femur<br>and fibula. |
| Substantial<br>Equivalence: | Information presented supports substantial equivalence. |

:

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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FEB - 3 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Lisa M. Boyle Regulatory Specialist Synthes (USA) 1690 Russel Road Paoli, Pennsylvania 19301

Re: K043185

Trade/Device Name: Synthes (USA) 3.5mm Cortex Screws Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: November 16, 2004 Received: November 17, 2004

Dear Ms. Boyle:

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 clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Lisa M. Boyle

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,

Mark McMillan

Celia M. Witten, Ph.D., M.D. 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:

2.0

Synthes (USA) 3.5 mm Cortex Screws

Indications for Use:

The Synthes 3.5 mm Cortex Screws are intended for fixation of fractures, osteotomies and nonunions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia, calcaneous, femur and fibula.

X Prescription Use (Per 21 CFR 801.109)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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

510(k) Number K043185