SYNTHES 2.4 MM CANNULATED COMPRESSION SCREW

K021556 · Synthes (Usa) · HWC · Aug 9, 2002 · Orthopedic

Device Facts

• Record ID: K021556
• Device Name: SYNTHES 2.4 MM CANNULATED COMPRESSION SCREW
• Applicant: Synthes (Usa)
• Product Code: HWC · Orthopedic
• Decision Date: Aug 9, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Synthes 2.4 mm Cannulated Compression Screw is intended for fixation of fractures and non-unions of small bones and small bone arthrodeses, including, but not limited to, scaphoid fractures; intra-articular fractures of the tarsals, metatarsals, carpals and metacarpals; bunionectomies and osteotomies; arthrodeses of small joints (e.g. phalanges); fractures of the patella, ulna and radial styloid.

Device Story

Synthes 2.4 mm Cannulated Compression Screw is a metallic bone fixation fastener; partially threaded; self-tapping and self-drilling design; cannulated for guidewire-assisted placement. Features StarDrive head; designed to sit flush or recessed below near cortex. Used by surgeons in clinical settings for small bone fracture fixation and arthrodesis. Provides mechanical stabilization of bone fragments to facilitate healing.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and design similarities to the predicate device.

Technological Characteristics

Material: Stainless steel. Design: Cannulated, partially threaded, self-tapping, self-drilling screw. Head: StarDrive. Dimensions: 2.4 mm diameter, various lengths. Energy source: None (mechanical).

Indications for Use

Indicated for fixation of fractures, non-unions, and arthrodeses of small bones, including scaphoid, tarsal, metatarsal, carpal, metacarpal, phalangeal, patellar, ulnar, and radial styloid bones; applicable for bunionectomies and osteotomies.

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 2.4 mm Cannulated Screw

Submission Summary (Full Text)

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AUG 0 9 2002

K021556
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## 3.0 510(k) Summary

| Sponsor: | Synthes (USA)<br>1690 Russell Road<br>Paoli, PA 19301<br>[phone]<br>Contact: Bonnie Smith |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Synthes 2.4 mm Cannulated Compression Screw |
| Classification: | Class II, as per Title 21 of the Code of Federal Regulations, Section<br>888.3040: "Smooth or threaded metallic bone fixation fastener". |
| Predicate Device: | Synthes 2.4 mm Cannulated Screw |
| Device Description: | Synthes 2.4 mm Cannulated Compression Screw is a partially threaded<br>self-tapping and self-drilling screw that can be guided into a position<br>using a guidewire. The threaded head is designed to be recessed below<br>or sit flush with the near cortex and features a StarDrive™ head.<br>Synthes 2.4 mm Cannulated Compression Screws are available in<br>various lengths. |
| Intended Use: | Synthes 2.4 mm Cannulated Compression Screw is intended for<br>fixation of fractures and non-unions of small bones and small bone<br>arthrodeses, including, but not limited to, scaphoid fractures; intra-<br>articular fractures of the tarsals, metatarsals, carpals and metacarpals;<br>bunionectomies and osteotomies; arthrodeses of small joints (e.g.<br>phalanges); fractures of the patella, ulna and radial styloid. |
| Materials: | Stainless steel |

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Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three wavy lines representing the department's mission. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

AUG 0 9 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Bonnie J. Smith Senior Regulatory Affairs Associate Synthes® (USA) 1690 Russell Road P.O. Box 1766 Paoli, PA 19301

Re: K021556

Trade/Device Name: Synthes(USA) 2.4 mm Cannulated Compression Screw Regulation Number: 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: May 10, 2002 Received: May 13, 2002

Dear Ms. Smith:

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. Bonnie J. Smith

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,

sincerely yours,

for Mark A. Millburn

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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## 2.0 Indications for Use Statement

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510(k) Number (if known):

Device Name:

INDICATIONS:

Synthes 2.4 mm Cannulated Compression Screw is intended for fixation of fractures and non-unions of small bones and small bone arthrodeses, including, but not limited to, scaphoid fractures; intra-articular fractures of the tarsals, metatarsals, carpals and metacarpals; bunionectomies and osteotomies; arthrodeses of small joints (e.g. phalanges); fractures of the patella, ulna and radial styloid.

Synthes (USA) 2.4 mm Cannulated Compression Screw

Mark N. Melkerson

vision of Cararal, Restorative and Neurolog cal Devices

510(k) Number: K021556

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-the-Counter Use

CONFIDENTIAL Premarket Notification 510(k): Synthes 2.4 mm Cannulated Compression Screw

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