IFS CANNULATED BONE SCREW

K061620 · Internal Fixation Systems, Inc. · HWC · Jul 26, 2006 · Orthopedic

Device Facts

• Record ID: K061620
• Device Name: IFS CANNULATED BONE SCREW
• Applicant: Internal Fixation Systems, Inc.
• Product Code: HWC · Orthopedic
• Decision Date: Jul 26, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Intended Use of the IFS Cannulated Bone Screw is for the treatment of bone fractures, such as fractures of the tarsals and metatarsals, and for metatarsals and phalangeal osteotomies and arthrodses of the hand and foot.

Device Story

IFS Cannulated Bone Screw is a self-tapping, self-drilling metallic screw; features cancellous thread; guided into position via guidewire. Available in partial or full thread configurations; diameters 3.0mm, 3.5mm, 4.0mm; lengths 10mm to 75mm. Used by surgeons in clinical settings for small bone fixation. Device provides mechanical stabilization of bone fragments to facilitate healing.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Material: 316L stainless steel. Design: Cannulated, self-tapping, self-drilling screw. Dimensions: 3.0-4.0mm diameter, 10-75mm length. Sterilization: Non-sterile, intended for end-user steam sterilization per AAMI/ISO 11737 guidelines.

Indications for Use

Indicated for treatment of bone fractures (tarsals, metatarsals) and metatarsal/phalangeal osteotomies and arthrodeses of the hand and foot.

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

• Precimed Cannulated Screw System (K050754)
• Nexa Bone Screw System (K053394)
• aap Cannulated Screw (K990776)
• Cannulated Bone Screws (K042310)
• Vilex Cannulated Screws (K991151)
• Vilex Cannulated Screws (K991197)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows a logo for Internal Fixation Systems. The logo consists of the letters IFS in a stylized font. A vertical line runs through the letters, with a spring-like design on the left side of the line. The words "INTERNAL FIXATION SYSTEMS" are printed in a smaller font below the letters.

JUL 2 6 2006

5619 N.W. 74th Avenue, Miami, Florida 33166

## Internal Fixation Systems, Inc. 510(k) Summary

| Company Name: | Internal Fixation Systems, Inc.<br>5619 N.W. 74th Avenue<br>Miami, Florida 33166 | | |
|--------------------------------------|----------------------------------------------------------------------------------------------------------------|-------------------------------------|--------------------|
| Contact Name: | Steve Hernandez<br>5619 N.W. 74th Avenue<br>Miami, Florida 33166<br>Phone [phone]<br>Fax [phone] | | |
| Trade Name: | IFS Cannulated Bone Screw | | |
| Common Name: | Cannulated Bone Screw | | |
| Regulation Name: | Smooth or Threaded Metallic Bone Fixation Fastener | | |
| Regulation Number: | 21 CFR 888.3040 | | |
| Regulatory Class: | II | | |
| Device Product<br>Code: | HWC | | |
| Substantially<br>Equivalent Devices: | Manufacturer | Trade Name | 510(k) Number |
| | Precimed, Inc. | Precimed Cannulated<br>Screw System | K050754 |
| | Nexa Orthopedics | Nexa Bone Screw System | K053394 |
| | aap Implants, Inc. | aap Cannulated Screw | K990776 |
| | Ortho-Pro LLC | Cannulated Bone Screws | K042310 |
| | Vilex, Inc. | Vilex Cannulated Screws | K991151<br>K991197 |

Device Description:

The IFS Cannulated Screw is a self-tapping, self-drilling screw

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Image /page/1/Picture/0 description: The image shows a logo with the letters IFS in a stylized font. The letters are connected by horizontal lines at the top and bottom. A vertical line runs through the left side of the letters, with a zigzag pattern on the left side of the line. Below the letters, the words "INTERNAL FIXATION SYSTEMS" are written in a smaller font.

5619 N.W. 74th Avenue, Miami, Florida 33166

with a cancellous thread that can be guided into position by guidewire placement. Partial or fully threaded screws are available in 3.0mm, 3.5mm, and 4.0mm thread diameters and 10mm to 75mm in length.

The intended use of the IFS Cannulated Bone Screw is for the Intended Use: treatment of bone fractures, such as fractures of the tarsals and metatarsals, and for metatarsals and phalangeal osteotomies and arthrodses of the hand and foot.

| Item | Internal Fixation Systems, Inc. | Precimed, Inc |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Name | IFS Cannulated Bone Screw | Precimed Cannulated Screw System |
| Use | Single Use | Single Use |
| Fixation Type | Screw | Screw |
| Material | 316L | 316L |
| Sizes | Various diameters and lengths for small bone fractures | Various diameters and lengths for small bone fractures |
| Indications for Use | The IFS Cannulated Bone Screw is indicated for use in the treatment of bone fractures, such as fractures of the tarsals and metatarsals, and for metatarsals and phalangeal osteotomies and arthrodses of the hand and foot. | The Precimed Cannulated Screw System is indicated for use in the treatment of bone fractures, such as fractures of the tarsals and metatarsals, and for metatarsals and phalangeal osteotomies and arthrodses of the hand and foot. |

Technological The IFS Cannulated Bone Screws are substantially equivalent to Characteristics the predicate devices with respect to design, material, and Comparison: indications for use.

Sterilization IFS Cannulated Bone Screws (devices) will be distributed nonsterile. The devices are sterilized by the end user per the AAMI Information: Guidelines "Good Hospital Practice: Steam Sterilization and Sterility Assurance" and ANSI/AAMI/ISO 11737 guidelines to achieve the Sterility Assurance Level (SAL) of 10 °.

- Conclusion: There are no significant differences between the Precimed Cannulated Screw System and the other devices as listed in the Substantially Equivalent Devices. The IFS device and the predicate devices have similar design attributes, material, and intended use thus is substantially equivalent.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is positioned within a circular border that contains the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 26 2006

Internal Fixation Systems, Inc. % Mr. Steve Hernandez President 5619 N.W. 74th Avenue Miami, Florida 33166

Re: K061620

Trade/Device Name: IFS Cannulated Bone Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: June 6, 2006 Received: June 9, 2006

Dear Mr. Hernandez:

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. Iisting 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 mav 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 clectronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.

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Page 2 -- Mr. Steve Hernandez

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/industry/support/index.html.

Sincerely yours,

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

Enclosure

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## Indications for Use

510(k) Number (if known):

Device Name: IFS Cannulated Bone Screw

Indications For Use: The Intended Use of the IFS Cannulated Bone Screw is for the treatment of bone fractures, such as fractures of the tarsals and metatarsals, and for metatarsals and phalangeal osteotomies and arthrodses of the hand and foot.

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (Part 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)

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