EXTREMITY MEDICAL MIDFOOT SCREW SYSTEM, CHARCX, INTRAMEDULLARY SCREW SYSTEM

K091577 · Extremity Medical, LLC · HWC · Jul 24, 2009 · Orthopedic

Device Facts

• Record ID: K091577
• Device Name: EXTREMITY MEDICAL MIDFOOT SCREW SYSTEM, CHARCX, INTRAMEDULLARY SCREW SYSTEM
• Applicant: Extremity Medical, LLC
• Product Code: HWC · Orthopedic
• Decision Date: Jul 24, 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, calcaneocuboid, and metatarsal-phalangeal joints.

Device Story

Metallic bone fixation fastener system used for arthrodesis of midfoot and metatarsal-phalangeal joints. Device consists of screws implanted by surgeons to provide rigid fixation across joint spaces to facilitate fusion. Operates via mechanical compression of bone segments. Used in clinical/surgical settings. Benefits include stabilization of joints to promote bone healing.

Clinical Evidence

Bench testing only.

Technological Characteristics

Metallic bone fixation fastener; smooth or threaded design; 21 CFR 888.3040 classification; Class II device.

Indications for Use

Indicated for fixation arthrodesis of metatarsal-cuneiform, navicular-cuneiform, metatarsal-cuboid, talonavicular, calcaneocuboid, and metatarsal-phalangeal 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

• EXTREMITY MEDICAL Midfoot Screw System (K082934)
• 3.5 Fully Threaded Screw, Synthes (K050683)

Submission Summary (Full Text)

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510(k) Premarket Notification

510(k) Summary of Safety and Effectiveness:

1JUL 2 4 7099

| 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 | May 28, 2009 |
| Trade Name | EXTREMITY MEDICAL Midfoot Screw System |
| Classification Name<br>and Number | Smooth or threaded metallic bone fixation fastener<br>21 CFR 888.3040 |
| Product Code | HWC |
| Predicate Devices | 1. EXTREMITY MEDICAL Midfoot Screw System K082934<br>2. 3.5 Fully Threaded Screw, Synthes K050683 |
| Device Description | The EXTREMITY MEDICAL Midfoot Screw System |
| Indications for use | The Extremity Medical Midfoot Screw System is intended for<br>fixation arthrodesis of the metatarsal-cuneiform, navicular-<br>cuneiform, metatarsal-cuboid, talonavicular, calcaneocuboid,<br>and metatarsal-phalangeal joints. |
| Statement of<br>Technological<br>Comparison | The EXTREMITY MEDICAL Midfoot Screw System and its<br>predicate devices have the same indications for use; have a<br>similar design; are made of similar materials, and have<br>equivalent mechanical properties. |
| Conclusion | The EXTREMITY MEDICAL Midfoot Screw System is<br>substantially equivalent to its predicate devices. This<br>conclusion is based upon indications for use, materials, design,<br>test data and principles of operation. |

## EXTREMITY MEDICAL Implant System

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle or other bird-like figure, with its wings spread and head turned to the right.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K091577

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: May 28, 2009 Received: June 2, 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.

(JUL 2 4 2009

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 (OS) 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 go to http://www.fda.gov/cdrh/comp/ for the Center for Devices and Radiological Health's

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Page 2 - Mr. Jamy Gannoe

(CDRH's) Office of Compliance. 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 go to http://www.fda.gov/cdrl/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 Buehup

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

Enclosure

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510(k) Premarket Notification

## Indications for Use

510(k) Number (if known): Device Name:

Indications for Use:

ר KO4 1577 EXTREMITY MEDICAL Midfoot Screw System

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

Prescription Use X_ AND/OR Over-the-counter (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ooutta for mxm
(Division Sign. Oth

Surgical, Orthopedic, and Restorative Devices

510(k) Number K091577