SYNTHES 2.4 MM CANNULATED SCREW

K012945 · Synthes (Usa) · HWC · Dec 3, 2001 · Orthopedic

Device Facts

• Record ID: K012945
• Device Name: SYNTHES 2.4 MM CANNULATED SCREW
• Applicant: Synthes (Usa)
• Product Code: HWC · Orthopedic
• Decision Date: Dec 3, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Synthes 2.4 mm Cannulated Screw is intended for fixation of fractures and non-unions of small bones and small bone arthrodeses. Examples include, but are not limited to scaphoid and other carpal fractures, metacarpal and phalangeal fusions, osteotomies, and bunionectomies.

Device Story

Synthes 2.4 mm Cannulated Screw is a machined metallic bone fixation device. Features cannulation for guidewire-assisted placement; self-tapping and self-drilling design. Used by surgeons in clinical/OR settings for small bone stabilization. Provides mechanical fixation to facilitate bone healing in fractures, non-unions, and arthrodeses. Benefits include precise placement via guidewire and reduced surgical complexity.

Clinical Evidence

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

Technological Characteristics

Machined metallic screw; materials: Stainless Steel or Titanium Alloy; cannulated design; self-tapping and self-drilling; 2.4 mm diameter.

Indications for Use

Indicated for fixation of fractures, non-unions, and arthrodeses of small bones, including scaphoid/carpal fractures, metacarpal/phalangeal fusions, osteotomies, and bunionectomies.

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.

Submission Summary (Full Text)

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## DEC 0 3 2001

K012945
page 1 of 1

## Summary of Safety and Effectiveness Information

| Sponsor | Synthes (USA)<br>1690 Russell Road<br>Paoli, PA 19301 |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company Contact | Matthew M. Hull<br>[phone] ext. 7191 |
| Name of the Device | Synthes 2.4 mm Cannulated Screw |
| Device Classification(s) | Class II, §888.3040 - Screw, Fixation, Bone |
| Substantial Equivalence | Documentation was provided which demonstrated the Synthes 2.4 mm<br>Cannulated Screw to be substantially equivalent to other legally<br>marketed devices. |
| Device Description | The Synthes 2.4 mm Cannulated Screw is a machined metallic screw<br>with a cannulation that is self-tapping and self-drilling and that can be<br>guided into position via a guidewire. |
| Indications | The Synthes 2.4 mm Cannulated Screw is intended for fixation of<br>fractures and non-unions of small bones and small bone arthrodeses.<br>Examples include, but are not limited to scaphoid and other carpal<br>fractures, metacarpal and phalangeal fusions, osteotomies, and<br>bunionectomies. |
| Materials | Stainless Steel or Titanium Alloy |

CONFIDENTIAL

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Image /page/1/Picture/12 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 0 3 2001

Mr. Matthew M. Hull Senior Regulatory Associate Synthes (USA) 1690 Russell Road P.O. Box 1766 Paoli, Pennsylvania 19301

Re: K012945

Trade/Device Name: Synthes (USA) 2.4 mm Cannulated Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or Threaded Metallic Bone Fixation Fastener Regulatory Class: II Product Code: HWC Dated: August 31, 2001 Received: September 4, 2001

Dear Mr. Hull:

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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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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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. Martin A. Milkman

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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Page 1 of 1

Indications for Use Statement

510(k) Number (if known):

Device Name:

Indications for Use:

K012945-

Synthes 2.4 mm Cannulated Screw

The Synthes 2.4 mm Cannulated Screw is intended for fixation of fractures and non-unions of small bones and small bone arthrodeses. Examples include, but are not limited to scaphoid and other carpal fractures, metacarpal and phalangeal fusions, osteotomies, and bunionectomies.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

તા ਮ Prescription Use (Per 21 CFR 801.109)

OR Over-The-Counter Use_No

Mark A Milliman

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

KO 12945

CONFIDENTA(K) Number

Synthes(USA) Synthes 2.4 mm Cannulated Screw 510(k)

000004