HammerFiX Device

K152710 · Extremity Medical, LLC · HWC · Oct 15, 2015 · Orthopedic

Device Facts

• Record ID: K152710
• Device Name: HammerFiX Device
• Applicant: Extremity Medical, LLC
• Product Code: HWC · Orthopedic
• Decision Date: Oct 15, 2015
• Decision: SESE
• Submission Type: Special
• 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 bone fixation device for lesser toe reconstruction. It consists of a sterile, threaded implant (PEEK or titanium alloy) and associated surgical instruments for site preparation and delivery. Available in multiple sizes (extra small to large) for use in proximal interphalangeal (PIP) joints. Used by orthopedic surgeons in clinical or surgical settings to stabilize bone segments following corrective procedures for hammertoe, claw toe, or mallet toe. The device provides mechanical fixation to facilitate bone healing and structural alignment of the toe.

Clinical Evidence

No clinical testing was performed. Substantial equivalence is supported by bench testing, including pull-out, torque, and bending tests compared to the predicate device.

Technological Characteristics

Metallic bone fixation fastener (21 CFR 888.3040). Materials: PEEK or titanium alloy. Form factor: Threaded implant in various sizes (extra small to large). Principle: Mechanical bone fixation. No software or electronic components.

Indications for Use

Indicated for patients requiring fixation of osteotomies and reconstruction of the lesser toes following 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

• HammerFiX (K133636)

Submission Summary (Full Text)

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September 8, 2016

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

Extremity Medical, LLC Brian Smekal VP, Regulatory Affairs and Quality Assurance 300 Interpace Parkway, Suite 410 Parsippany, New Jersey 07054

Re: K152710

Trade/Device Name: HammerFix Device Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: September 18, 2015 Received: September 21, 2015

Dear Mr. Brian Smekal:

This letter corrects our substantially equivalent letter of October 15, 2015.

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 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

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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 Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

## Mark N. Melkerson -S

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

Enclosure

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See PRA Statement below.

Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

## Indications for Use

510(k) Number (if known)

K152710

Device Name HammerFiX Device

Indications for Use (Describe)

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.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

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

### HammerFiX Device

| Submitter: | Extremity Medical, LLC.<br>300 Interpace Parkway<br>Suite 410<br>Parsippany, NJ 07054 |
|---------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Brian Smekal, MS, RAC<br>VP, Regulatory Affairs and Quality Assurance<br>Phone: [phone]<br>Email: [e-mail] |
| Date Prepared | October 13, 2015 |
| Trade Name | HammerFiX Device |
| Classification Name<br>and Number | Smooth or threaded metallic bone fixation fastener |
| Classification Name<br>and Number | 21 CFR 888.3040 |
| Product Code | HWC (screw, fixation, bone) |
| Predicate Devices | K133636 - HammerFiX (Extremity Medical) |
| Device Description | The HammerFiX device is a bone fixation device consisting of a sterile, threaded<br>PEEK or titanium alloy implant and a set of instruments used for implant site<br>preparation and delivery. The device is offered in extra small, small, medium and<br>large implant sizes to allow for use in the proximal interphalangeal (PIP) joints<br>of 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 hammertoe,<br>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 and bending was performed and<br>compared to the predicate device. |
| Clinical Testing | No clinical testing was performed. |
| Conclusion | The HammerFiX device is substantially equivalent to its predicate device. This<br>conclusion is based upon indications for use, design, test data and principles of<br>operation. |