ASNIS MICRO CANNULATED SCREW

K071092 · Howmedica Osteonics Corp. · HWC · May 11, 2007 · Orthopedic

Device Facts

• Record ID: K071092
• Device Name: ASNIS MICRO CANNULATED SCREW
• Applicant: Howmedica Osteonics Corp.
• Product Code: HWC · Orthopedic
• Decision Date: May 11, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Asnis™ III Cannulated Screw System is intended for fracture fixation of small and long bones and of the pelvis. The system is not intended for spinal use.

Device Story

Asnis™ III Cannulated Screw System is a line extension of metallic bone fixation fasteners. Device consists of cannulated screws used by surgeons for internal fracture fixation of small bones, long bones, and the pelvis. System is not for spinal use. Device functions as a mechanical implant to stabilize bone fragments. Clinical benefit is stabilization of fractures to facilitate healing. No software or electronic components involved.

Clinical Evidence

Bench testing only. Mechanical testing was conducted to compare the strength of the subject device to predicate screws, demonstrating substantial equivalence in strength.

Technological Characteristics

Metallic bone fixation fastener; cannulated screw design; intended for internal fixation. No software, energy source, or connectivity features.

Indications for Use

Indicated for fracture fixation of small and long bones and of the pelvis. Not indicated for spinal use.

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

• Asnis™ III Cannulated Screw System (K000080)
• Asnis™ III Cannulated Screw System (K024060)
• Vilex 2mm Screws (K973309)
• Vilex 2mm Screws (K991151)
• Vilex 2mm Screws (K991197)
• Synthes Cannulated Screws (K962823)

Submission Summary (Full Text)

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#### K071092 1/1

# Summary of Safety and Effectiveness Asnis™ III Cannulated Screw System Line Extension

MAY 1 1 2007

| Proprietary Name: | Asnis™ Micro Cannulated Screw |
|------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Bone Screw |
| Classification Name and Reference: | Smooth or Threaded Metallic Bone<br>Fixation Fastener, 21 CFR §888.3040 |
| Proposed Regulatory Class: | Class II |
| Device Product Code: | 87 HWC: Screw, Fixation, Bone |
| For Information contact: | Vivian Kelly, Sr. Regulatory Affairs Specialist<br>Howmedica Osteonics Corp.<br>325 Corporate Drive<br>Mahwah, NJ 07430<br>Phone: [phone]<br>Fax: [phone] |
| Date Summary Prepared: | April 17, 2007 |

## Description:

This Special 510(k) submission is a line extension to address modifications to the Asnis™ III Cannulated Screw System. This line extension is to add additional sizes of screws to the system.

## Intended Use

The modifications do not alter the intended use of the predicate systems as cleared in their respective premarket notifications. The indications for use for the subject device are provided below.

## Indications

The Asnis™ III Cannulated Screw System is intended for fracture fixation of small and long bones and of the pelvis. The system is not intended for spinal use.

#### Substantial Equivalence:

These additional components are substantially equivalent to their predicate systems in respect to design, intended use, performance and operational principle as internal fixation components. Predicate systems include the Asnis™ III Cannulated Screw System (K000080 and K024060) and other commercially available cannulated screws on the market such Vilex 2mm Screws (K973309, K991151 & K991197) and Synthes Cannulated Screws (K962823.) Mechanical testing was conducted to compare the strength of the subject device to predicate screws. The results demonstrate that the subject components are substantially equivalent in strength to the predicate components.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

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Image /page/1/Picture/12 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three overlapping wings, symbolizing health, human services, and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the eagle in a circular fashion.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# MAY 1 1 2007

Howmedica Osteonics Corporation % Ms. Vivian Kelly, RAC Senior Regulatory Affairs Specialist 325 Corporate Drive Mahwah, New Jersey 07430

Re: K071092

Trade/Device Name: Asnis™ III Cannulated Screw System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth of threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: April 17, 2007 Received: April 18, 2007

Dear Ms. Kelly:

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. Vivian Kelly, RAC

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 vours.

Obarbare Bruckner

Mark N. Melkerson 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: Asnis™ III Cannulated Screw System

Indications for Use:

The Asnis™ III Cannulated Screw System is intended for fracture fixation of small and long bones and of the pelvis. The system is not intended for spinal use.

Prescription Use Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

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(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

| 510(k) Number | K071092 |
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