OSTEOMED EXTENDED 2.0/2.4CANNULATED SCREW SYSTEM

K062863 · Osteomed LP · HWC · Oct 31, 2006 · Orthopedic

Device Facts

• Record ID: K062863
• Device Name: OSTEOMED EXTENDED 2.0/2.4CANNULATED SCREW SYSTEM
• Applicant: Osteomed LP
• Product Code: HWC · Orthopedic
• Decision Date: Oct 31, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Osteomed Extended 2.0/2.4 Cannulated Screw System is indicated for bone fixation of hand and foot following trauma or osteotomy. Screws and washers are intended for single use only.

Device Story

The OsteoMed Extended 2.0/2.4 Cannulated Screw System consists of titanium alloy bone screws (2.0mm and 2.4mm diameters) and associated surgical instrumentation (depth gauges, screwdrivers, drills, countersinks, k-wires). The system is used by surgeons in clinical settings for internal bone fixation following trauma or osteotomy. The screws are cannulated to allow for placement over k-wires. The device provides mechanical stabilization of bone fragments to facilitate healing. All components are intended for single use only.

Clinical Evidence

No clinical data provided; substantial equivalence is based on bench testing and design/material comparisons to predicate devices.

Technological Characteristics

Materials: Titanium alloy (ASTM F-136). Components: Cannulated screws (2.0mm-2.4mm diameter, 6mm-52mm length), washers, and manual surgical instruments (drills, drivers, k-wires). Energy source: None (manual). Sterilization: Not specified.

Indications for Use

Indicated for bone fixation of hand and foot following trauma or osteotomy in patients requiring surgical stabilization.

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

• Osteomed Cannulated Screw Systems (K010783)
• Osteomed Cannulated Screw Systems (K954330)
• BioPro Digital Compression Screw (K963433)
• Millennium Medical Technologies Percutaneous Compression Wire (K031050)

Submission Summary (Full Text)

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Kα62863

## 510(k) Summary

OCT 3 1 2006

Device Proprietary Name:

OsteoMed Extended 2.0/2.4 Cannulated Screw System

Device Common Name:

Classification Name:

HWC, Screw, Fixation, Bone

Name of Submitter:

OsteoMed L. P. 3885 Arapaho Road Addison, Texas 75001 Phone: [phone] Fax: [phone]

Contact Person:

Dawn D. Tindall

Bone Screw

Date Prepared:

September 22, 2006

Summary:

This submission describes the OsteoMed Extended 2.0/2.4 Cannulated Screw System indicated for bone fixation of hand and foot following trauma or osteotomy. Screws and washers are intended for single use only.

The OsteoMed Extended 2.0/2.4 Cannulated Screw System is comprised of screws in diameters of 2.0mm (length 6mm to 42mm) to 2.4mm (length 6mm to 52mm). The screws are made from titanium alloy (ASTM F-136). Depth gauges, screwdrivers, drills, countersinks, k-wires, and preparation instruments will also be a part of the system.

Equivalence for this device is based on similarities in intended use, material, design and operational principle to the Osteomed Cannulated Screw Systems (K010783 and K954330), the BioPro Digital Compression Screw (K963433) and the Millennium Medical Technologies Percutaneous Compression Wire (K031050).

Due to the similarity of materials and design to both pre-enactment and postenactment devices, OsteoMed believes that the OsteoMed Extended 2.0/2.4 Cannulated Screw System does not raise any new safety or effectiveness issues.

OsteoMed L.P. 3885 Arapaho Road Addison, Texas 75001 [phone] FAX: [phone] Customer Service: [phone]

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## OCT 3 1 2006

OsteoMed L.P. % Ms. Dawn D. Tindall Regulatory Affairs 3885 Arapaho Road Addison, Texas 75001

Re: K062863

Trade/Device Name: OsteoMed Extended 2.0/2.4 Cannulated Screw System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener. Regulatory Class: Class II Product Code: HWC Dated: September 22, 2006 Received: September 28, 2006

Dear Ms. Tindall:

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. Dawn D. Tindall

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

Koz Pelo Ntm

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): KO62863

Device Name: __ OsteoMed Extended 2.0/2.4 Cannulated Screw System

Indications for Use:

The Osteomed Extended 2.0/2.4 Cannulated Screw System is indicated for bone fixation of hand and foot following trauma or osteotomy. Screws and washers are intended for single use only.

Prescription Use (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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

**(Division Sign-Off)**

Om Division of General, Restorativ Page of and Neurological Devices

510(k) Number_ 166242

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