HANSSON PIN SYSTEM

K033968 · Howmedica Osteonics Corp. · HTY · Feb 20, 2004 · Orthopedic

Device Facts

• Record ID: K033968
• Device Name: HANSSON PIN SYSTEM
• Applicant: Howmedica Osteonics Corp.
• Product Code: HTY · Orthopedic
• Decision Date: Feb 20, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Hansson™ Pin System is intended for use in the temporary stabilization of types of fractures of the proximal femur. The subject device is indicated for fixation of proximal femoral fractures including but not limited to: - Intracapsular fractures of the femoral neck such as Transcervical and Subcapital Neck Fractures - Basal Neck Fractures - Slipped Capital Femoral Epiphysis (in pediatric patients) .

Device Story

Hansson™ Pin System is a hip fracture fixation device for temporary stabilization of proximal femur fractures. System consists of pins and an outer sleeve; modified to include titanium alloy fabrication and an end cap. Dimension changes to the outer sleeve improve deployment and removal of the inner pin. Used by orthopedic surgeons in a clinical/surgical setting to provide mechanical fixation of bone fractures. Device provides structural support to stabilize fractures during the healing process.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Metallic bone fixation fastener (21 CFR 888.3040). Materials: Titanium alloy. Components: Pins, outer sleeve, end cap. Mechanical fixation principle. Sterilization method not specified.

Indications for Use

Indicated for fixation of proximal femoral fractures, including intracapsular femoral neck fractures (transcervical, subcapital), basal neck fractures, and slipped capital femoral epiphysis (SCFE) in pediatric patients.

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

• Hansson™ Pin System (K964893)

Reference Devices

• ASNIS™ II Cannulated Bone Screws
• ASNIS™ III Cannulated Bone Screws

Submission Summary (Full Text)

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K033968 Page 1 of 1

510(k) PremarketNotification

| Proprietary Name: | Hansson™ Pin System |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Hip Fracture Fixation Device |
| Classification Name and Reference | Smooth or Threaded Metallic Bone Fixation Fastener<br>21 CFR §888.3040 |
| Regulatory Class: | Class II |
| Device Product Code: | 87 HTY: Pin, Fixation, Smooth |
| For Information contact: | Vivian Kelly, Regulatory Affairs Specialist<br>Howmedica Ostconics Corp.<br>325 Corporate Drive<br>Mahwah, NJ 07430<br>Phone: [phone]<br>Fax: [phone] |
| Date Summary Prepared: | 12/18/03 |

# 510(k) Summary for the Hansson™ PinSystem Line Extension

#### Description:

The Hansson" Pin is a hip fracture system designed to treat various types of fractures of the proximal femur. This premarket notification is a line extension to modify the existing Hansson™ Pin System, which was cleared via K964893. The indications for use are being expanded to include additional types of proximal femoral fractures. Also, several dimension changes have been made to the predicate device's outer sleeve to improve the deployment and removal of the inner pin. In addition, the Hansson" Pin will also be fabricated from Titanium Alloy and an end cap will be added to the product line.

#### Intended Use:

The Hansson" Pin System is intended for use in the temporary stabilization of various types of fractures of the proximal femur. The subject device is indicated for fixation of proximal fractures including but not limited to:

- intracapsular fractures of the femoral neck such as transcervical and subcapital neck fractures, .
- basal neck fractures, and .
- slipped capital femoral epiphysis (SCFE) in pediatric patients. .

#### Substantial Equivalence:

The design and function of the Hansson" Pin are substantially equivalent to that of the predicate devices. Both the subject and predicate Hansson" Pin Systems offer pins in varying lengths while the ASNIS" II & III Cannulated Bone Screws are indicated for the fixation of Slipped Capital Femoral Epiphysis.

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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 consists of a stylized eagle or bird symbol with three curved lines representing its wings or feathers. The bird is positioned above a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a sans-serif font. The text is arranged around the circumference of the circle, with the bird symbol placed in the center.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 0 2004

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

Re: K033968

Trade/Device Name: Hansson" Pin System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Codes: HTY Dated: December 18, 2003 Received: December 22, 2003

Dear Ms. Kelly:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bection of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosals) to regary and the Medical Device Amendments, or to commerce pror to may 20, 1978, the encordance with the provisions of the Federal Food, Drug, de vices that have been rochasined in quire approval of a premarket approval application (PMA). and Cosmeter For (110) the envice, subject to the general controls provisions of the Act. The r ou may, dicierore, mance of the Act include requirements for annual registration, listing of general controls provision 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 n your de rice to such additional controls. Existing major regulations affecting your device can may be subject to bach address legulations, 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 r head be aar made a determination that your device complics with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or any 1 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 Of It 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

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,

Sincerely yours,

Mark N Mulkerson

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): K033968

Device Name: Hansson™ Pin System

### Intended Use

The Hansson™ Pin System is intended for use in the temporary stabilization of types of fractures of the proximal femur. The subject device is indicated for fixation of proximal femoral fractures including but not limited to:

- Intracapsular fractures of the femoral neck such as Transcervical and Subcapital Neck . Fractures
- Basal Neck Fractures .
- Slipped Capital Femoral Epiphysis (in pediatric patients) .

| Prescription Use. | X |
|-----------------------------|---|
| (Part 21 CFR 801 Subpart D) | |

AND/OR

Over-The-Counter Use _ (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

**510(k) Number** K033968