BOWTI ANTERIOR BUTTRESS STAPLE SYSTEM

K021039 · Depuyacromed · KWQ · Dec 11, 2002 · Orthopedic

Device Facts

• Record ID: K021039
• Device Name: BOWTI ANTERIOR BUTTRESS STAPLE SYSTEM
• Applicant: Depuyacromed
• Product Code: KWQ · Orthopedic
• Decision Date: Dec 11, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The BowTi Anterior Buttress Staple System, in conjunction with traditional rigid fixation, is intended for use in spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts or autografts. This device is not intended for load bearing applications.

Device Story

BowTi Anterior Buttress Staple System is a spinal fixation accessory; consists of titanium alloy staples and self-tapping cancellous screws. Staple features two prongs for vertebral body engagement to prevent rotation and a screw slot for final fixation; 5-degree bend; available in 20mm and 24mm sizes. Screws have 6.25mm major diameter; available in 20mm, 25mm, and 30mm lengths. Used in spinal fusion procedures to maintain position of bone grafts; intended for use alongside traditional rigid fixation systems. Not for load-bearing applications. Operated by surgeons in clinical/OR settings. Provides mechanical stabilization of graft material to facilitate fusion.

Clinical Evidence

Bench testing only. Biomechanical testing, including static and fatigue cantilever beam loading, was conducted to evaluate performance.

Technological Characteristics

Materials: Titanium alloy (Ti-6Al-4V) per ASTM F-136. Components: Staples (20mm, 24mm) with 5-degree bend and two prongs; self-tapping cancellous screws (6.25mm diameter, 20-30mm lengths). Finish: Smooth anodized. Mechanical fixation principle. Non-load bearing.

Indications for Use

Indicated for patients undergoing spinal fusion procedures requiring maintenance of relative position of weak bony tissue (allografts or autografts) in conjunction with traditional rigid fixation. Not for load-bearing applications.

Regulatory Classification

Identification

A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.

Predicate Devices

• MacroPore OS Spinal System (K010911)

Submission Summary (Full Text)

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| IX. 510(k) Summary | | | |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|-------------|
| SUBMITTER: | DePuy AcroMed™, Inc.<br>325 Paramount Drive<br>Raynham, MA 02767-0350 USA | | K 02103 |
| CONTACT PERSON: | Karen F. Jurczak<br>Phone: [phone]<br>Fax: [phone] | | page 1 |
| DATE PREPARED: | November 01, 2002 | | DEC 11 2002 |
| PROPRIETARY NAME: | BowTi Anterior Buttress Staple System | | |
| CLASSIFICATION NAME: | Appliance, Fixation, Spinal Intervertebral Body | | |
| PREDICATE DEVICE: | MacroPore OS Spinal System (K010911) | | |
| INTENDED USE: | The BowTi Anterior Buttress Staple System, in conjunction<br>with traditional rigid fixation, is intended for use in spinal<br>fusion procedures as a means to maintain the relative<br>position of weak bony tissue such as allografts or<br>autografts. This device is not intended for load bearing<br>applications. | | |
| MATERIALS: | ASTM F-136 Material (Ti-6Al-4V) | | |
| PERFORMANCE DATA: | Biomechanical testing, including static and fatigue<br>cantilever beam loading, were conducted. | | |
| DEVICE DESCRIPTION: | The BowTi Anterior Buttress Staple System consists of a | | |

- The BowTi Anterior Buttress Staple System consists of a DEVICE DESCRIPTION: staple and a screw. The staple is uniquely shaped to conform to the anatomy of the anterior spine. It features two prongs, which engage the vertebral body and prevent rotation, and a screw slot for final fixation. The staples have a 5-degree bend, and are available in two sizes, 20mm and 24mm. The self-tapping cancellous screws have a 6.25mm major diameter and are available in lengths of 20mm, 25mm, and 30mm. Both components of BowTi Anterior Buttress Staple System are the manufactured from titanium alloy and have a smooth anodized finish.
K OD 1039

page (o

DEC 11 2002

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing movement or connection.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 -

DEC 11 2002

Ms. Karen F. Jurczak Depuy Acromed'" 325 Paramount Drive Raynham, Massachusetts 02767-0350

Re: K021039

Trade/Device Name: BowTi Anterior Buttress Staple System Regulation Number: 21 CFR §888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWQ Dated: November 1, 2002 Received: November 4, 2002

Dear Ms. Jurczak;

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. Karen F. Jurczak

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,

Mark n Milliman

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

HFZ-401 DMC cc: HFZ-404 510(k) Staff HFZ-410 DGRND D.O. f/t:MMattera:elh:12/09/02

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BowTi Anterior Buttress Staple System

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## IV. Indications for Use

K021039 510(k) Number (if known):

BowTi Anterior Buttress Staple System Device Name:

Indications For Use:

The BowTi Anterior Buttress Staple System, in conjunction with traditional rigid fixation, is intended for use in spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts or autografts. This device is not intended for load bearing applications.

(Please do not write below this line - continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

OR Over-The-Counter Use: Prescription Use: (Per 21 CFR 801.109)

to Mark N. Melleus

(Division Sign-Off) Dision of General, Restorative Jeurological Devices

Number K02/039