KOBY SURGICAL INTERNAL FIXATION SYSTEM

K060026 · Koby Surgical · HWC · Jan 26, 2006 · Orthopedic

Device Facts

• Record ID: K060026
• Device Name: KOBY SURGICAL INTERNAL FIXATION SYSTEM
• Applicant: Koby Surgical
• Product Code: HWC · Orthopedic
• Decision Date: Jan 26, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Koby Surgical Internal Fixation System implants are intended for fixation of fractures, non-unions, arthrodeses and osteotomies of the small bones in the hand and foot. The implants are intended for single use only. These implants are not intended for attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.

Device Story

Koby Surgical Internal Fixation System consists of cannulated and non-cannulated bone screws of varying diameters and lengths; constructed from implant-grade titanium alloy (Ti-6AL-4V ELI). Used by surgeons for internal fixation of small bones in hand and foot; provides mechanical stabilization for fractures, non-unions, arthrodeses, and osteotomies. Single-use only. Not for spinal use.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use.

Technological Characteristics

Constructed from implant-grade titanium alloy (Ti-6AL-4V ELI). System comprises cannulated and non-cannulated bone screws of varying diameters and lengths. Mechanical fixation device.

Indications for Use

Indicated for fixation of fractures, non-unions, arthrodeses, and osteotomies of small bones in the hand and foot. Contraindicated for attachment or fixation to posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

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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Image /page/0/Picture/0 description: The image shows the logo for Koby Surgical. The text "Koby Surgical" is in a large, bold font, with a line underneath each word. Below this, the text "Innovations in Foot Surgery" is in a smaller font.

1635 Houston, TX Phone: [phone] Fax: [phone]

JAN 2 6 2006

## 510(k) Summary

| Date Prepared: | December 29, 2005 |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sponsor: | Koby Surgical<br>16350 Park Ten Place, Suite 101<br>Houston, TX 77084 |
| Company Contact: | Perry Forrester<br>Phone: [phone]<br>Fax: [phone] |
| Device Trade Name: | Koby Surgical™ Internal Fixation System |
| Classification Name: | Smooth & threaded metallic bone fixation fasteners (21 CFR<br>888.3040, Product Code HWC, Class II) |
| Common Name: | Bone Screw or Internal Fixation Device (non-spinal) |
| Substantial Equivalence: | Documentation is provided which demonstrates the Koby<br>Surgical Internal Fixation System to be substantially equivalent<br>to other legally marketed devices. |
| Device Description: | The Koby Surgical Internal Fixation System consists of a series<br>of cannulated and non-cannulated bone screws which vary in<br>diameters and lengths. These screws are constructed from<br>implant-grade titanium and are used to aid in the fixation of<br>bones in the upper and lower extremities. |
| Intended Usage: | The Koby Surgical Internal Fixation System implants are<br>intended for fixation of fractures, non-unions, arthrodeses and<br>osteotomies of the small bones in the hand and foot.<br>The<br>implants are intended for single use only. |
| | These implants are not intended for attachment or fixation to the<br>posterior elements (pedicles) of the cervical, thoracic or lumbar<br>spine. |
| Material: | Titanium Alloy (Ti-6AL-4V ELI) |

## Section 5 – Page 1 of 1

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 6 2006

Mr. Perry Forrester President Koby Surgical 16350 Park Ten Place, Suite 101 Houston, Texas 77084

Re: K060026

Trade/Device Name: Koby Surgical Internal Fixation System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: December 29, 2005 Received: January 4, 2006

Dear Mr. Forrester:

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 - Mr. Forrester

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" (21 CFR 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 yours.

Barbara Buchund
for

Mark N. Melkerson, Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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cc: HFZ-401 DMC HFZ-404 510(k) Staff
HFZ-410 Division D.O. f/t:NKM:rrr: 1/25/06

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## Indications for Use

510(k) Number: Pending

Device Name: Koby Surgical Internal Fixation System

Indications For Use:

The Koby Surgical Internal Fixation System implants are intended for fixation of fractures, non-unions, arthrodeses and osteotomies of the small bones in the hand and foot. The implants are intended for single use only.

These implants are not intended for attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.

Prescription Use V (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Saubare Bried for MXM

is on Sign-O Division of General, Restorative, and Neurological Devices

**510(k) Number** K060026