SYNTHES 5.0/7.3 MM CANNULATED LOCKING SCREWS

K040765 · Synthes (Usa) · JDW · Apr 12, 2004 · Orthopedic

Device Facts

• Record ID: K040765
• Device Name: SYNTHES 5.0/7.3 MM CANNULATED LOCKING SCREWS
• Applicant: Synthes (Usa)
• Product Code: JDW · Orthopedic
• Decision Date: Apr 12, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Synthes 5.0/7.3 mm Cannulated Locking screws are intended to be used with existing Synthes LCP® plating systems for the fixation of various long bones, such as the femur.

Device Story

Synthes 5.0/7.3 mm Cannulated Locking Screws are orthopedic bone fixation fasteners. Features include self-drilling and self-tapping tips, flat head profile with rounded edges, and hex drive recess. Screws are available in lengths ranging from 100mm to 145mm. Designed to engage with threaded holes of existing Synthes LCP® plating systems. Used by surgeons in clinical settings for long bone fixation, such as the femur. Device provides mechanical stability to bone fractures or osteotomies via locking mechanism with plating system.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Material: Stainless steel. Design: Cannulated, self-drilling, self-tapping, flat head with hex drive. Dimensions: 5.0/7.3 mm diameter, 100-145 mm length. Connectivity: None. Energy source: None. Sterilization: Not specified.

Indications for Use

Indicated for the fixation of various long bones, such as the femur, in patients requiring bone fixation using Synthes LCP® plating systems. Prescription use only.

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 5.0/7.3 mm Cannulated Locking Screws (K040765)

Submission Summary (Full Text)

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APR 1 2 2004

040765
page 1 of 1

## 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 5.0/7.3 mm Cannulated Locking Screws |
| CLASSIFICATION: | Class II § 21 CFR 888.3040: Smooth or Threaded Metallic Bone Fixation<br>Fastener. |
| PREDICATE DEVICE: | Synthes 5.0/7.3 mm Cannulated Locking Screws |
| DEVICE DESCRIPTION: | The Synthes 5.0/7.3 mm Cannulated Locking Screws feature self-drilling<br>and self-tapping tips, have a flat head profile with rounded edges with a hex<br>drive recess. They are available in additional lengths ranging from 100 -<br>145mm. The threads below the head of each locking screw are designed to<br>engage with the threaded holes of currently marketed Synthes LCP®<br>plating systems. |
| INTENDED USE: | Synthes 5.0/7.3 mm Cannulated Locking screws are intended to be used<br>with existing Synthes LCP® plating systems for the fixation of various long<br>bones, such as the femur. |
| SUBSTANTIAL<br>EQUIVALENCE: | Comparative information presented supports substantial equivalence. |
| MATERIAL | Stainless Steel |

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Confidential

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is a stylized symbol consisting of three abstract human figures connected by flowing lines, representing the department's focus on people and their well-being.

Public Health Service

APR 1 2 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Rc: K040765

Trade/Device Name: Synthes (USA) 5.0/7.3 mm Cannulated Locking Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: JDW Dated: March 24, 2004 Received: March 25, 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 adultcration.

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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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,

L. Mark A. Mulhausen

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 _________________________________________________________________________________________________________________________________________________________________

K040765 510(k) Number (if known):

Synthes (USA) 5.0/7.3 mm Cannulated Locking Screw Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications: Synthes 5.0/7.3 mm Cannualted Locking Screws are intended to be used with existing Synthes LCP® plating systems for the fixation of various long bones, such as the femur.

X Prescription Use (Per 21 CFR 801.109)

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Over-The-Counter Usc

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Synthes (USA)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sig...)

**Division of General, Restorative,
and Neurological Devices**

Confidential 510(k) N: K040765

Confidential

Synthes (USA) 5.0/7/3 mm Cannulated Locking Screws

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