MULTITAK SS BUTTONS

K990156 · Bonutti Research · MBI · Mar 5, 1999 · Orthopedic

Device Facts

• Record ID: K990156
• Device Name: MULTITAK SS BUTTONS
• Applicant: Bonutti Research
• Product Code: MBI · Orthopedic
• Decision Date: Mar 5, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Multitak SS Buttons are new fixation devices indicated in orthopedic fracture and in ligament and tendon repair. The buttons allow for stabilization and linear fixation of bone fragments in fracture procedures. The buttons also serve as fixation posts for distributing suture tension over areas of ligament and tendon repair. The buttons are made of titanium, polypropylene, or polyethylene and are provided sterile with or without suture attached and are not intended for reuse. Maximum suture size to be used with each of the buttons are outlined in the following table:

Device Story

Multitak SS Buttons are cylindrical fixation devices used in orthopedic surgery to stabilize bone fragments or serve as fixation posts for ligament and tendon repair. The device consists of a tubular button applied to the outer bone cortex over a pre-drilled hole. Suture is passed through the bone hole and secured to the button, providing linear fixation and compression to promote healing. The buttons are used by surgeons in clinical settings. By distributing suture tension over the fracture or repair site, the device facilitates tissue healing. The buttons are provided sterile, single-use, and are available in various sizes and materials (titanium, polypropylene, or UHMWPE).

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Cylindrical/tubular buttons; materials: Ti-6Al-4V alloy, polypropylene, and UHMWPE. Dimensions range from 1.2 mm x 4.0 mm to 3.0 mm x 10.0 mm. Provided sterile. Mechanical fixation principle via suture tension distribution.

Indications for Use

Indicated for orthopedic fracture repair and ligament/tendon repair in patients requiring bone fragment stabilization or suture tension distribution.

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

• Kirschner Wires and Steinmann Pins (K961522)
• Ethicon, Inc. Polypropylene Buttons (Class I)
• Multitak SS Suture System - Titanium Soft Tissue Anchor (K973015)
• Multitak SS Suture System - UHMWPE Soft Tissue Anchor (K964532)

Submission Summary (Full Text)

{0}------------------------------------------------

3/5/99

K990156

#### Bonutti Research, Inc. - Multitak SS Buttons 510(k) Premarket Notification

#### 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

Inc following information is submitted in accordance with the requirements of 21 CFR 807.92

Contact Person: Patnek Balsmann, MS, RAC, Manager, QA/RA & Clinical Bonulli Research, Inc. P O Box 1367, Ettingham, Illinois 62401 Phone [phone] ext 321

Date Prepared: March i 1999

Proprietary Name: Multitak SS Buttons

Common Name: Fracture Fixation Device and Surgical Buttons.

Classification Name: 21 CFR 888 3040 Smooth Or Threaded Metallic Bone Fixation Fastener and 21 CFR 878 4930 Suture Retemion Device

Device Description: The Multitak SS Buttons are fixation devices indicated in orthopedic fracture and in ligament and tendon repair They are intended to stabilize two or more bone hagments and distribute suture tension over the fracture site in order to facilitate healing. The buttons also serve as fixation posts for distributing surure tension over areas of ligament and renden repair The cyundneal buttons are made from titanium, polypropylene, or polyethylene and have an overali ratio of approximately 3 1, length to diameter. The buttons are available in the tollowing sizes ( ! ) ! 2 mm in diameter and 4 0 mm in length, (2) 1 8 mm in diameter and o 0 mm in length (3) 2 5 mm in diameter and 8 3 mm in length, and (4) 3 0 mm in diameter and I min in lengin The buttons are applied to the outer bone cortex over a prednilled hole across the manufe she Bone fragments are stabilized with suture running through the drill bone hole and off at the button The buttons provide linear fixation and compression of the bone trapments promoting healing at the fracture site Buttons can also be used as fixation posts and are praced outside the corucal bone in ligament and tendon repair. They provide a means of distributing suture tension over areas of repaired ligaments and tendons. The buttons are provided sterile with or without attached suture in packs of two and are not intended for reuse.

intended Use: The Multiak SS Buttons are new fixation devices indicated in orthopedic fracture and in ligament and tendon repair The buttons allow for stabilization and linear fixation of bone fragments in fracture procedures The buttons also serve as fixation posts for arste buting subure tension over areas of ligament and tendon repair. The buttons are made of " manne polyerhylene or polyethylene and are provided sterile with or without suture attached and are not intended for reuse. Maximum surure size to be used with each of the buttons are out ned in the following table

{1}------------------------------------------------

# Bonutti Research, Inc. -- Multitak SS Buttons S10(k) Summary of Safety and Effectiveness Page 2

| Multitak SS Button Size | Button Material | Maximum USP Suture Size |
|-------------------------|------------------------------------------------------|-------------------------|
| 3.0 mm x 10.0 mm | Ti-6Al-4V | Up to USP Size 2 |
| 3.0 mm x 10.0 mm | Polypropylene | Up to USP Size 2 |
| 3.0 mm x 10.0 mm | Ultra-high-molecular-weight<br>polyethylene (UHMWPE) | Up to USP Size 2 |
| 7.5 mm x 8.3 mm | Ti-6Al-4V | Up to USP Size 2 |
| 7.5 mm x 8.3 mm | Polypropylene | Up to USP Size 1 |
| 7.5 mm x 8.3 mm | UHMWPE | Up to USP Size 1 |
| 7.8 mm x 6.0 mm | Ti-6Al-4V | Up to USP Size 2 |
| 7.2 mm x 4.0 mm | Ti-6Al-4V | Up to USP Size 2-0 |

Predicate Device: The Multitak SS Buttons are similar in intended use to Kirschner Wires and Steinmann Pins manufactured by Synvasive Technology, Inc. (K961522) and to Ethicon, Inc., Polypropyiene Buttons regulated as Class I surgical buttons. The Multitak SS Buttons are similar in design and materials to the Multitak SSTM Suture System soft tissue suture anchor devices manufactured by Bonutt: Research, Inc (K973015 and K964532.)

Predicate Comparison: A chart comparing characteristics of the The Multitak SS Buttons to to as of the predicate devices is attached

Submitted by:

yielde more

Patrick Balsmann Manager, QARA & Clinical

{2}------------------------------------------------

## Benner Kevneh, bie - Meltink SS Buttons 410gkt Promonten Natifustion JRHuxa v

| Device<br>Characteristic | Mulfitek SS<br>Buttons | Symante<br>Technology, Inc<br>Kirschmer Wires and<br>Steinmann Pins | Ethicon, Inc.<br>Polypropylene<br>Surgical Buttons | Mulfitek SS<br>Suture System -<br>Titanium Soft Tissue<br>Anchor | Mulfitek SS<br>Suture System -<br>UHMWPE Soft<br>Tissue Anchor |
|--------------------------|----------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------|-------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | Current Submission | K961522 | Class I | K973015 | K964532 |
| Intended Use | Stabilize two or more<br>bone fragments by<br>distributing suture<br>tension over fracture<br>site | Draw two or more<br>bone fragments<br>together to facilitate<br>healing | Aid wound healing by<br>distributing suture<br>tension over contact<br>surface area | Soft tissue to bone<br>suture fixation | Soft tissue to bone<br>suture fixation |
| Indications | Bone fracture repair<br>Ligament and tendon<br>repair | Bone fracture repair | Orthopedic tendon<br>repair | Shoulder, elbow,<br>knee, foot/ankle, and<br>hand/wrist soft tissue<br>to bone orthopedic<br>applications | Shoulder, elbow,<br>knee, and foot/ankle,<br>soft tissue to bone<br>orthopedic<br>applications |
| Design | Tubular buttons<br>approximate ratio of<br>3:1 length to<br>diameter | Sized K-wires and<br>pins | 14 mm diameter<br>round buttons. | Cylindrical anchors<br>approximate ratio of<br>2:1 length to<br>diameter. | Tubular anchors<br>approximate ratio of<br>2:1 length to<br>diameter. Single and<br>double anchor tube<br>constructs |
| Material | Titanium (Ti-6Al-4V)<br>alloy, polypropylene;<br>and polyethylene<br>(UHMWPE.) | Stainless steel. | Polypropylene. | Titanium (Ti-6Al-4V)<br>alloy and stainless<br>steel. | Polyethylene<br>(UHMWPE.) |
| Provided Sterile | Sterile. | Sterile and non-<br>sterile. | Sterile. | Sterile. | Sterile. |

.

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a circular design with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle are three stylized human profiles facing to the right, with flowing lines suggesting movement or connection.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 5 1999

Patrick G. Balsmann, M.S., RAC Manager, QA/RA and Clinical Affairs Bonutti Research, Inc. P.O. Box 1367 62401 Effingham, Illinois

Re: K990156 Multitak SS Button Regulatory Class: II Product Codes: MBI and GAT January 14, 1999 Dated: Received: January 19, 1999

#### Dear Mr. Balsmann:

We have reviewed your Section 510(k) 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Failure to Administration (FDA) will verify such assumptions. comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

{4}------------------------------------------------

Page 2 - Patrick G. Balsmann, M.S., RAC

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Russell Vayga

M. Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

## Bonutti Research, Inc. -- Multitak SS Buttons 510(k) Premarket Notification

# INDICATIONS FOR USE

Device Name: Multitak SS Buttons.

Indications for Use: The Multitak SS Buttons are new fixation devices indicated in orthopedic fracture and in ligament and tendon repair. The buttons allow for stabilization and linear fixation of bone fragments in fracture procedures. The buttons also serve as fixation posts for distributing suture tension over areas of ligament and tendon repair. The buttons are made of titanium, polypropylene, or polyethylene and are provided sterile with or without suture attached and are not intended for reuse. Maximum suture size to be used with each of the buttons are outlined in the following table:

| Multitak SS Button Size | Button Material | Maximum USP Suture Size |
|-------------------------|------------------------------------------------------|-------------------------|
| 3.0 mm x 10.0 mm | Ti-6Al-4V | Up to USP Size 2 |
| 3.0 mm x 10.0 mm | Polypropylene | Up to USP Size 2 |
| 3.0 mm x 10.0 mm | Ultra-high-molecular-weight<br>polyethylene (UHMWPE) | Up to USP Size 2 |
| 2.5 mm x 8.3 mm | Ti-6Al-4V | Up to USP Size 2 |
| 2.5 mm x 8.3 mm | Polypropylene | Up to USP Size 1 |
| 2.5 mm x 8.3 mm | UHMWPE | Up to USP Size 1 |
| 1.8 mm x 6.0 mm | Ti-6Al-4V | Up to USP Size 2 |
| 1.2 mm x 4.0 mm | Ti-6Al-4V | Up to USP Size 2-0 |

**Prescription Use**
(Per 21 CFR 801.109)

Aurell V. Hogan for me

(Division Sign-Off) ি। .. - eral Resto Birn, vamber .

1 i