SYNTHES 4.0MM TITANIUM (TI.) LOCKING SCREWS

K032559 · Synthes (Usa) · HRS · Oct 22, 2003 · Orthopedic

Device Facts

• Record ID: K032559
• Device Name: SYNTHES 4.0MM TITANIUM (TI.) LOCKING SCREWS
• Applicant: Synthes (Usa)
• Product Code: HRS · Orthopedic
• Decision Date: Oct 22, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Synthes 4.0mm Ti. Locking screws are intended to be used with existing Synthes LCP® plating systems for the fixation of various long bones, such as the humerus, femur and tibia.

Device Story

Synthes 4.0mm Titanium Locking Screws are orthopedic bone fixation fasteners. Device features self-tapping tip, stardrive mechanism, and flat head profile with rounded edges. Available in lengths 14mm to 90mm. Designed to engage with threaded holes of existing Synthes LCP® plating systems. Used by surgeons in clinical settings for internal fixation of long bone fractures. Provides mechanical stability to bone segments during healing process.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Material: Titanium Alloy. Design: Self-tapping tip, stardrive mechanism, flat head profile. Dimensions: 4.0mm diameter, 14mm-90mm length. Function: Threaded locking mechanism for LCP® plating systems.

Indications for Use

Indicated for fixation of long bones, including humerus, femur, and tibia, using Synthes LCP® plating systems.

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 4.0 mm Stainless Steel Locking Screws

Submission Summary (Full Text)

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OCT 22 2003

## 3.0 Summary of Safety and Effectiveness Information [510(k) Summary]

| SPONSOR: | Synthes (USA)<br>1690 Russell Road<br>Paoli, PA 19301<br>[phone]<br>Contact: Lisa M. Boyle |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| DEVICE NAME: | Synthes 4.0mm Titanium (Ti.) Locking Screws |
| CLASSIFICATION: | Class II § 21 CFR 888.3040: Smooth or Threaded Metallic Bone Fixation<br>Fastener. |
| PREDICATE DEVICE: | Synthes 4.0 mm Stainless Steel Locking Screws |
| DEVICE DESCRIPTION: | The Synthes 4.0mm Ti. Locking Screws feature a self-tapping tip, stardrive<br>mechanishm, and have a flat head profile with rounded edges. They are<br>available in lengths ranging from 14mm to 90mm. The threads below the<br>head of each locking screw are designed to engage with the threaded holes<br>of currently marketed Synthes LCP® plating systems. |
| INTENDED USE: | Synthes 4.0mm Ti. Locking screws are intended to be used with existing<br>Synthes LCP® plating systems for the fixation of various long bones, such<br>as the humerus, femur and tibia. |
| SUBSTANTIAL<br>EQUIVALENCE: | Comparative information presented supports substantial equivalence. |
| MATERIAL | Titanium Alloy |

Confidential

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle.

Public Health Service

OCT 2 2 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Lisa M. Boyle Regulatory Associate Synthes (USA) 1690 Russell Road Post Office Box 1766 Paoli, PA 19301

Re: K032559

Trade/Device Name: Synthes (USA) 4.0mm Titanium Locking Screws Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HRS Dated: August 18, 2003 Received: August 19, 2003

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 electronic 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/dsma/dsmamain.html

Sincerely yours,

Mark N. Mikkelson

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 Statement 2.0

Page 1 of 1

| 510(k) Number (if known): | k032559 |
|---------------------------|---------------------------------------------|
| Device Name: | Synthes (USA) 4.0mm Titanium Locking Screws |

Indications: Synthes 4.0mm Titanium Locking Screws are intended to be used with existing Synthes LCP® plating systems for the fixation of various long bones, such as the humerus, femur and tibia.

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## Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use_

Monk N. Miller

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

K032554

Confidential