ARROWHEAD FIXATION DEVICE

K100926 · Arrow Products, Inc. · HTY · Oct 29, 2010 · Orthopedic

Device Facts

• Record ID: K100926
• Device Name: ARROWHEAD FIXATION DEVICE
• Applicant: Arrow Products, Inc.
• Product Code: HTY · Orthopedic
• Decision Date: Oct 29, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Arrowhead is indicated for fixation of osteotomies, arthrodeses and reconstruction in the lesser toes following corrective procedures. It is not intended for use in the spine.

Device Story

Arrowhead Fixation Device is an intramedullary bone fastener used for fixation of lesser toe osteotomies, arthrodeses, and reconstructions. The device features a three-dimensional arrow shape and is available in multiple lengths and two angles. Manufactured from stainless steel, it is designed for single-use. The device is intended for use by surgeons in clinical settings. It provides mechanical stability to bone segments during healing. Substantial equivalence was demonstrated through mechanical bench testing, including rotational forces, pull-out, and four-point bend testing, confirming performance comparable to predicate K-wires.

Clinical Evidence

Bench testing only. No clinical data provided. Equivalence established via rotational forces testing, pull-out testing, and four-point bend testing.

Technological Characteristics

Intramedullary bone fastener; stainless steel construction; three-dimensional arrow shape; available in multiple lengths and two angles; single-use; mechanical fixation principle.

Indications for Use

Indicated for fixation of osteotomies, arthrodeses, and reconstruction in lesser toes following corrective procedures. Not for use in the spine.

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

• newdeal, S.A. K-wire (K022599)
• Arthrex, Inc. K-wire (K052736)
• Nexa Orthopedics, Inc. Nexfix Compression Pin (K072710)
• BioPro Inc., DCS (K963433)
• Wright Medical Technologies, Inc. PRO-TOE VO Hammertoe (K101165)
• Merete Medical GMBH PRO TOE Endosorb Small Hammer Toe Pin (K100414)

Submission Summary (Full Text)

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OCT 2 9 2010

# 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

### ARROWHEAD FIXATION DEVICE - K100926

| Submitted by: | Arrowhead Products LLC<br>2593 Lake Erma Drive<br>Hampton, GA 30228 |
|-------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | September 18, 2010 |
| Contact Person: | Scott R. Roman, DPM<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Proprietary Name: | Arrowhead Fixation Device |
| Common Name | Intramedullary Bone Fastener |
| Device<br>Classification<br>Regulation | 21 CFR 888.3040 - Class II |
| Device Product<br>Code and Panel | HTY: Pin, Fixation, Smooth<br>87 Orthopedics |
| Device Description | The Arrowhead Fixation Device implant features a three dimensional<br>arrow shape. The implants are available in multiple lengths and in 2<br>different angles. The implant is manufactured from stainless steel and is<br>designed for single use only. |
| Intended Use | The Arrowhead is indicated for fixation of osteotomies, arthrodeses and<br>reconstruction in the lesser toes following corrective procedures. It is not<br>intended for use in the spine. |
| Predicate Devices | newdeal, S.A. K-wire (K022599)<br>Arthrex, Inc. K-wire (K052736)<br>Nexa Orthopedics, Inc. Nexfix Compression Pin (K072710)<br>BioPro Inc., DCS (K963433)<br>Wright Medical Technologies, Inc. PRO-TOE VO Hammertoe (K101165)<br>Merete Medical GMBH PRO TOE Endosorb Small Hammer Toe Pin<br>(K100414) |
| Technological<br>Characteristics | The Arrowhead Fixation Device has similar technological characteristics<br>when compared to the predicate devices. In addition, substantial<br>equivalence was shown through Rotational Forces Testing, Pull-out<br>Testing and Four-Point Bend Testing. The testing confirmed that the<br>Arrowhead Fixation Device is at least equivalent to the newdeal K-wire. |
| Substantial<br>Equivalence<br>Information | The Arrowhead Fixation Device is similar to legally marketed devices<br>including the newdeal K-wire, Arthrex K-wire, Nexfix Compression Pin,<br>BioPro DCS, PRO-TOE VO Hammertoe, and the PRO TOE Endosorb<br>Small Hammer Toe Pin. The Arrowhead Fixation Device has similar<br>indications for use and technological characteristics as these predicate<br>systems. While the Arrowhead Fixation System includes an arrow design<br>at the ends of the device, mechanical testing confirmed that the device is<br>substantially equivalent to the newdeal K-wire. Therefore, the Arrowhead<br>Device System is determined to be substantially equivalent to the<br>predicate devices. |

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### 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS ARROWHEAD FIXATION DEVICE - K100926

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings, and three curved lines below representing its talons. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

Arrow Products. Inc. c/o Dr. Scott Roman Podiatrist 2593 Lake Erma Drive Hampton, Georgia 30228

OCT 2 9 2010

Re: K100926 .

Trade/Device Name: Arrowhead Fixation Device Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener. Regulatory Class: Class II Product Code: HTY Dated: October 26, 2010 Received: October 27, 2010

Dear Dr. Roman:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

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Page 2 - Dr. Scott Roman

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (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/MedicalDevices/Safety/ReportaProblem/default.htm 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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mulh N Mllkuss

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

Enclosure

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# Indications for Use

510(k) Number (if known): K100926

Device Name: Arrowhead Fixation Device

Indications for Use:

The Arrowhead is indicated for fixation of osteotomies, arthrodeses and reconstruction in the lesser toes following corrective procedures. It is not intended for use in the spine.

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)

Sonata for mxm

(Di Sion Sign O Division of Surgical, Offhopedic, and Restorative Devices

510(k) Number K100926

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