EXTREMITY MEDICAL MIDFOOT SCREW SYSTEM

K082934 · Extremity Medical, LLC · HWC · Apr 23, 2009 · Orthopedic

Device Facts

• Record ID: K082934
• Device Name: EXTREMITY MEDICAL MIDFOOT SCREW SYSTEM
• Applicant: Extremity Medical, LLC
• Product Code: HWC · Orthopedic
• Decision Date: Apr 23, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Extremity Medical Midfoot Screw System is intended for fixation arthrodesis of the metatarsal-cuneiform, navicular-cuneiform, metatarsal-cuboid, talonavicular, and calcaneocuboid joints.

Device Story

The Extremity Medical Midfoot Screw System consists of metallic bone fixation fasteners used for arthrodesis of specific midfoot joints. The device is implanted by a surgeon to provide mechanical stabilization and fixation of the metatarsal-cuneiform, navicular-cuneiform, metatarsal-cuboid, talonavicular, and calcaneocuboid joints. By securing these joints, the system facilitates bone fusion, aiding in the treatment of midfoot instability or deformity. The device is intended for prescription use in a clinical or surgical setting.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design, material, and mechanical property comparisons.

Technological Characteristics

Metallic bone fixation fastener (smooth or threaded). Materials are similar to predicate devices. Device is a mechanical implant system.

Indications for Use

Indicated for fixation arthrodesis of the metatarsal-cuneiform, navicular-cuneiform, metatarsal-cuboid, talonavicular, and calcaneocuboid joints.

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

• 3.5 Fully Threaded Screw, Synthes (K050683)
• EXTREMITY MEDICAL Compression Screw (K081934)
• Pioneer Medical, Stayfuse (K022726)
• 6.5 Midfoot Fusion Bolt, Synthes (K081071)

Submission Summary (Full Text)

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K082934 1/1

EXTREMITY

APR 2 3 2009

## 510k Summary of Safety and Effectiveness

## Extremity Medical Implant System

| Submitter: | EXTREMITY MEDICAL LLC<br>300 Interpace Parkway<br>Suite 410<br>Parsippany, NJ 07054 |
|---------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Jamy Gannoe<br>President<br>Phone: [phone]<br>Email: [e-mail] |
| Date Prepared | April 13, 2009 |
| Trade Name | EXTREMITY MEDICAL Midfoot Screw System |
| Classification Name and<br>Number | Smooth or threaded metallic bone fixation fastener<br>21 CFR 888.3040 |
| Product Code | HWC |
| Predicate Devices | 1. 3.5 Fully Threaded Screw , Synthes K050683<br>2. EXTREMITY MEDICAL Compression Screw K081934<br>3. Pioneer Medical, Stayfuse K022726<br>4. 6.5 Midfoot Fusion Bolt, Synthes K081071 |
| Device Description | The EXTREMITY MEDICAL Midfoot Screw System |
| Indications for use | The Extremity Medical Midfoot Screw System is intended for fixation<br>arthrodesis of the metatarsal-cuneiform, navicular-cuneiform,<br>metatarsal-cuboid, talonavicular, and calcaneocuboid joints. |
| Statement of<br>Technological<br>Comparison | The EXTREMITY MEDICAL Midfoot Screw System and its predicate<br>devices have the same indications for use; have a similar design; are<br>made of similar materials, and have equivalent mechanical<br>properties. |
| Conclusion | The EXTREMITY MEDICAL Midfoot Screw System is substantially<br>equivalent to its predicate devices. This conclusion is based upon<br>indications for use, materials, design, test data and principles of<br>operation. |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three overlapping wings, representing health, services, and people. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## APR 2 3 2009

EXTREMITY MEDICAL LLC % Mr. Jamy Gannoe 300 Interpace Parkway, Suite 410 Parsippany, NJ 07054

Re: K082934

Trade/Device Name: EXTREMITY MEDICAL Midfoot Screw System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: April 13, 2009 Received: April 14, 2009

Dear Mr. Gannoe:

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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at

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Page 2 - Mr. Jamy Gannoe

[phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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, A

Yor Dhol

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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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Image /page/3/Picture/0 description: The image shows the logo for Extremity Medical. The logo features the word "EXTREMITY" in bold, sans-serif font, with a stylized "X" that resembles a person with outstretched arms. Below the word "EXTREMITY" is the word "MEDICAL" in a smaller, less bold font. The logo is simple and modern, and it conveys a sense of strength and innovation.

## Indications for Use

510(k) Number (if known): K082934

Device Name:

EXTREMITY MEDICAL Midfoot Screw System

Indications for Use:

"The Extremity Medical Midfoot Screw System is intended for fixation arthrodesis of the metatarsalcuneiform, navicular-cuneiform, metatarsal-cuboid, talonavicular, and calcaneocuboid joints"

Over-the-counter Prescription Use X AND/OR

(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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(Division Sign-Off) (Division Digit of General, Restorative, Division - Problem Devices

**510(k) Number** L682934

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