EXTREMITY MEDICAL HAMMERTOE DEVICE

K133636 · Extremity Medical, LLC · HWC · Mar 28, 2014 · Orthopedic

Device Facts

• Record ID: K133636
• Device Name: EXTREMITY MEDICAL HAMMERTOE DEVICE
• Applicant: Extremity Medical, LLC
• Product Code: HWC · Orthopedic
• Decision Date: Mar 28, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The HammerFiX device is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe and mallet toe.

Device Story

HammerFiX is a sterile, threaded PEEK bone fixation implant; used for proximal interphalangeal (PIP) joint fixation in lesser toes. System includes implant and associated surgical instruments for site preparation and delivery. Available in small, medium, and large sizes. Used by surgeons in clinical settings during hammertoe, claw toe, or mallet toe correction procedures. Implant provides mechanical stability to bone segments post-osteotomy to facilitate reconstruction. Benefit is secure fixation of lesser toe deformities.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including pull-out, torque, static, and dynamic bending tests compared to predicate devices.

Technological Characteristics

Material: PEEK. Form factor: Threaded bone fixation fastener in small, medium, and large sizes. Principle: Mechanical bone fixation via threaded implant. Sterilization: Sterile. Connectivity: None. Software: None.

Indications for Use

Indicated for fixation of osteotomies and reconstruction of lesser toes in patients undergoing correction procedures for hammertoe, claw toe, and mallet toe.

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

• PRO-TOET™ VO Hammertoe Implant System (K120645)
• Intraosseous Fixation System (K120165)
• Kirschner Wires (K073674)
• ActivaPin™ Pin (K061164)
• Subtalar Implant (K071498)
• Healix ADVANCE™ PEEK Anchor (K120449)

Submission Summary (Full Text)

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

| Submitter: | Extremity Medical, LLC.<br>300 Interpace Parkway, Suite 410<br>Parsippany, NJ 07054 |
|---------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Brian Smekal, MS, RAC<br>Director, Regulatory Affairs<br>Phone: [phone]<br>Email: [e-mail] |
| Date Prepared | January 31, 2014 |
| Trade Name | HammerFiX |
| Classification Name<br>and Number | Smooth or threaded metallic bone fixation fastener<br>21 CFR 888.3040 |
| Product Code | HWC (screw, fixation, bone) |
| Predicate Devices | K120645 - PRO-TOET™ VO Hammertoe Implant System (Wright Medical)<br>K120165 - Intraosseous Fixation System (Ortho Helix Surgical Designs, Inc.)<br>K073674 - Kirschner Wires (Signal Medical Corp.)<br>K061164 - ActivaPin™ Pin (Bioretec Ltd.)<br>K071498 - Subtalar Implant (Biomet Sports Medicine)<br>K120449 - Healix ADVANCE™ PEEK Anchor (Depuy Mitek) |
| Device Description | The HammerFiX device is a bone fixation device consisting of a sterile,<br>threaded PEEK implant and a set of instruments used for implant site<br>preparation and delivery. The device is offered in small, medium and large<br>implant sizes to allow for use in the proximal interphalangeal (PIP) joints of<br>the lesser toes of the foot. |
| Indications for use | The HammerFiX device is indicated for the fixation of osteotomies and<br>reconstruction of the lesser toes following correction procedures for<br>hammertoe, claw toe and mallet toe. |
| Statement of<br>Technological<br>Comparison | The HammerFiX device and predicate devices are equivalent in terms of<br>indications for use, design, and material mechanical properties. |
| Non-clinical Testing | Bench testing, including pull-out, torque, static and dynamic bending were<br>performed and compared to the predicate device. |
| Clinical Testing | No clinical testing was performed. |
| Conclusion | The HammerFiX device is substantially equivalent to its predicate device.<br>This conclusion is based upon indications for use, principles of operation,<br>design, and mechanical test data. |

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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 and Human Services. The logo consists of a stylized depiction of an eagle with three curved lines representing its wings. The eagle is positioned to the right of a circular text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is arranged around the circumference of the circle.

Public Health Service

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

March 28, 2014

Extremity Medical, L.L.C. Mr. Brian Smekal, M.S., RAC Director, Regulatory Affairs 300 Interspace Parkway, Suite 410 Parsippany, New Jersey 07054

Re: K133636

Trade/Device Name: HammerFiX Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: February 14, 2014 Received: February 18, 2014

Dear Mr. Smekal:

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 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

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Page 2 - Mr. Brian Smekal, M.S., RAC

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 Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address htto://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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,

## Lori A. Wiggins

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

Enclosure

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## Indications for Use

510(k) Number (if known): K133636 Device Name: HammerFiX Indications for Use:

The HammerFiX device is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe and mallet toe.

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)

## Elizabet标逐渐被冻rank -S

Division of Orthopedic Devices