EXTREMITY MEDICAL COMPRESSION SCREW

K081934 · Extremity Medical, LLC · HWC · Aug 29, 2008 · Orthopedic

Device Facts

• Record ID: K081934
• Device Name: EXTREMITY MEDICAL COMPRESSION SCREW
• Applicant: Extremity Medical, LLC
• Product Code: HWC · Orthopedic
• Decision Date: Aug 29, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Extremity Medical Compression Screw is intended for reduction and internal fixation of arthrodeses, osteotomies, intra- and extra-articular fractures and nonunions of the small bones and joints of the foot and hand. Examples include scaphoid fractures, tarsal and metatarsal fracture, hand, wrist, foot and ankle arthrodeses, metacarpal and metatarsal arthrodeses, distal radius fractures.

Device Story

The Extremity Medical Compression Screw is a metallic bone fixation fastener used for internal fixation and reduction of small bone fractures, osteotomies, and arthrodeses in the hand and foot. It is intended for use by surgeons in a clinical or operating room setting. The device provides mechanical stabilization to bone segments to facilitate healing. It is a passive implantable device; it does not involve electronic inputs, software, or automated processing.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Metallic bone fixation fastener; material composition is similar to predicate devices. Device is a screw-type implant for small bone applications. No software, electronics, or energy sources involved.

Indications for Use

Indicated for reduction and internal fixation of arthrodeses, osteotomies, intra- and extra-articular fractures, and nonunions of small bones and joints in the hand and foot, including scaphoid, tarsal, metatarsal, and distal radius fractures.

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

• Synthes, Compression Screw (K050636)
• Newdeal, I.CO.S (K993762)
• Kinetikos Medical, Inc., Kompressor (K024233)

Submission Summary (Full Text)

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K081934

510(k) Premarket Notification

## 510(k) Summary of Safety and Effectiveness:

# AUG 2 9 2008

### 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 | August 15, 2008 |
| Trade Name | EXTREMITY MEDICAL Compression Screw |
| Classification Name<br>and Number | Smooth or threaded metallic bone fixation fastener<br>21 CFR 888.3040 |
| Product Code | HWC |
| Predicate Devices | 1. Synthes, Compression Screw K050636<br>2. Newdeal, I.CO.S K993762<br>3. Kinetikos Medical, Inc., Kompressor K024233 |
| Device Description | The EXTREMITY MEDICAL Compression Screw |
| Indications for use | The Extremity Medical Compression Screw is intended for<br>reduction and internal fixation of arthrodeses, osteotomies,<br>intra- and extra-articular fractures and nonunions of the small<br>bones and joints of the foot and hand. Examples include<br>scaphoid fractures, tarsal and metatarsal fracture, hand, wrist,<br>foot and ankle arthrodeses, metacarpal and metatarsal<br>arthrodeses, distal radius fractures. |
| Statement of<br>Technological<br>Comparison | The EXTREMITY MEDICAL Compression Screw and its<br>predicate devices have the same indications for use have a<br>similar design and are made of the similar materials. |
| Conclusion | The EXTREMITY MEDICAL Compression Screw is<br>substantially equivalent to its predicate devices. This<br>conclusion is based upon the fact that this device is substantially<br>equivalent in terms of indications for use, materials, design and<br>principles of operation. |

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Public Health Service

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

#### AUG 2 9 2008

Extremity Medical LLC % Mr. Jamy Gannoe President 300 Interpace Parkway, Suite 410 Parsippany, New Jersey 07054

Re: K081934

Trade/Device Name: EXTREMITY MEDICAL Compression Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: July 2, 2008 Received: July 7, 2008

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 (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); 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. Jamy Gannoe

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N Mulhusan

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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510(k) Premarket Notification

Screw

### Indications for Use

| 510(k) Number (if known): | |
|---------------------------|-------------------------------|
| Device Name: | EXTREMITY MEDICAL Compression |
| Indications for Use: | |

The Extremity Medical Compression Screw is intended for reduction and internal fixation of arthrodeses, osteotomies, intra- and extra-articular fractures and nonunions of the small bones and joints of the foot and hand. Examples include scaphoid fractures, tarsal and metatarsal fracture, hand, wrist, foot and ankle arthrodeses, metacarpal and metatarsal arthrodeses, distal radius fractures.

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)

Mark M. Mikkelsen

and I

510(k) Number