MODIFICATION TO ASNIS III CANNULATED SCREW SYSTEM

K024060 · Howmedica Osteonics Corp. · HWC · Dec 20, 2002 · Orthopedic

Device Facts

• Record ID: K024060
• Device Name: MODIFICATION TO ASNIS III CANNULATED SCREW SYSTEM
• Applicant: Howmedica Osteonics Corp.
• Product Code: HWC · Orthopedic
• Decision Date: Dec 20, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Asnis III Cannulated Screw System 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; metallic bone fixation device. Modifications include additional lengths for 8.0 mm diameter screws and modified core thread diameter for 6.5 mm diameter screws. Used for fracture fixation of small and long bones and pelvis. Not for spinal use. Mechanical testing confirms substantial equivalence to predicate devices.

Clinical Evidence

Bench testing only.

Technological Characteristics

Metallic bone fixation appliance; cannulated screw design. Materials, packaging, and sterilization are identical to predicate devices. No software or electronic components.

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.

Submission Summary (Full Text)

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## Special 510(k) Summary: Device Modification to the Asnis III Cannulated Screw System

| Submission Information | |
|--------------------------------------------------------------|--------------------------------------------------------------------------------------------------|
| Name and Address of the Sponsor<br>of the 510(k) Submission: | Howmedica Osteonics Corp<br>59 Route 17<br>Allendale, NJ 07401-1677 |
| Contact Person: | Karen Ariemma<br>Regulatory Affairs Specialist |
| Date of Summary Preparation: | December 6, 2002 |
| Device Identification | |
| Proprietary Name: | Asnis III Cannulated Screw System |
| Common Name: | Bone Screw |
| Classification Name and Reference: | Single/multiple component metallic bone fixation<br>appliances and accessories, 21 CFR §888.3030 |

This Special 510(k) submission is intended to address design modifications to the Asnis III Cannulated Screw System. Additional lengths have been added to the 8.0 mm diameter screws. The core thread diameter of the 6.5 mm diameter screws has been modified. The material, intended use, packaging and sterilization of the subject devices are identical to those of predicate devices.

#### Intended Use

The intended use of the modified devices, as described in its labeling, has not changed as a result of this modification. These devices are intended for fracture fixation of small and long bones and of the pelvis. The system is not intended for spinal use.

### Statement of Technological Comparison

Mechanical testing and analysis demonstrates comparable properties of the subject to the predicate device.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the logo is an abstract symbol that resembles an eagle or bird in flight, composed of three stylized human profiles facing to the right.

# Public Health Service

DEC 2 0 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Karen Ariemma Regulatory Affairs Specialist Stryker Howmedica Osteonics Corp. 59 Route 17 South Allendale, New Jersey 07401-1677

Re: K024060 -

Trade Name: Asnis III Cannulated Screw System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and

accessories

Regulatory Class: II Product Code: HWC Dated: December 6, 2002 Received: December 9, 2002

Dear Ms. Ariemma:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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. Karen Ariemma

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,

Muriam C. Puvot

for 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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# 510(k) Number (if known): KO 2 40 60

Device Name: Asnis III Cannulated Screw System

Indications for Use

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use メ

OR

Over-The-Counter Use

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

Miriam C. Provost

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

Number K029060