The Hammertoe Correction System

K153065 · Life Spine, Inc. · HWC · Aug 1, 2016 · Orthopedic

Device Facts

• Record ID: K153065
• Device Name: The Hammertoe Correction System
• Applicant: Life Spine, Inc.
• Product Code: HWC · Orthopedic
• Decision Date: Aug 1, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Life Spine HAMMERTOE Correction System is indicated for small bone reconstruction limited to inter-digital repar and fusion of the lesser toes.

Device Story

The Hammertoe Correction System is a dual-threaded titanium implant designed for surgical fixation of the lesser toes. It is inserted between the proximal and middle phalanges; the opposing threads engage the phalangeal canal to provide joint compression and stabilization. The device is intended for single-use only and is utilized by orthopedic surgeons in a clinical or surgical setting to facilitate bone fusion. By providing mechanical fixation, the implant supports the reconstruction of small bones, potentially improving toe alignment and patient comfort.

Clinical Evidence

Bench testing only. Evidence includes Finite Element Analysis, custom shear testing, and bench-top validations to demonstrate substantial equivalence.

Technological Characteristics

Dual-threaded implant fabricated from 6AL-4V-ELI titanium (ASTM F136). Non-sterile, single-use components. Mechanical fixation via threaded engagement in the phalangeal canal.

Indications for Use

Indicated for small bone reconstruction, specifically inter-digital repair and fusion of the lesser toes.

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

• Arthrex BioPin (K050259)
• Life Spine Cannulated Screws (K150126)

Submission Summary (Full Text)

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

August 1, 2016

Life Spine, Incorporated Mr. Randy Lewis General Manager 13951 South Quality Drive Huntley, Illinois 60142

Re: K153065

Trade/Device Name: The Hammertoe Correction System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: May 27, 2016 Received: May 31, 2016

Dear Mr. Lewis:

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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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/Resourcesfor You/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 yours,

# 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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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

K153065

Device Name

The Hammertoe Correction System

Indications for Use (Describe)

The Life Spine HAMMERTOE Correction System is indicated for small bone reconstruction limited to inter-digital repar and fusion of the lesser toes.

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

| <div> <span> <svg height="12" width="12"> <rect height="12" style="fill:none;stroke-width:2;stroke:black" width="12"></rect> <line style="stroke:black;stroke-width:2" x1="0" x2="12" y1="0" y2="12"></line> <line style="stroke:black;stroke-width:2" x1="0" x2="12" y1="12" y2="0"></line> </svg> </span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span> <svg height="12" width="12"> <rect height="12" style="fill:none;stroke-width:2;stroke:black" width="12"></rect> </svg> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |
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# 510(k) Summary Hammertoe Correction System

| Submitted By: | Life Spine, Inc.<br>13951 S. Quality Drive<br>Huntley, IL 60142<br>Telephone: [phone]<br>Fax: [phone] |
|--------------------|--------------------------------------------------------------------------------------------------------------------------|
| 510(k) Contact: | Randy Lewis<br>Life Spine<br>13951 S. Quality Drive<br>Huntley, IL 60142<br>Telephone: [phone]<br>Fax: [phone] |
| Date Prepared: | June 27th, 2016 |
| Trade Name: | Hammertoe Correction System |
| Regulation Name: | Smooth or Threaded Metallic Bone Fixation Fastener |
| Classification: | HWC, CFR 888.3040, Class II |
| Primary Predicate: | Arthrex BioPin (K050259)<br>Life Spine Cannulated Screws (K150126) |

#### Device Description:

The Hammertoe Correction System is an implant with dual threaded design and is inserted between the proximal and middle phalanges, so the opposing threads fixate on the phalangeal canal of the toe and compress the joint. The implant is fabricated and manufactured from Titanium (Ti 6A1-4V ELI)

All implants are intended for single use only and should not be reused under any circumstances. Do not use any of the Hammertoe Correction System components with components from any other system or manufacturer. The Hammertoe Correction System components should never be reused under any circumstances.

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#### Indications for Use of the Device:

The Hammertoe Correction System is indicated for small bone reconstruction limited to interdigital repair and fusion of the lesser toes.

## Technological Characteristics:

The Hammertoe Correction System is substantially equivalent to the predicate system in terms of design, indications for use and sizing.

#### Material:

The Hammertoe Correction System is 6AL-4V-ELI titanium manufactured according to ASTM F136. The device is comprised of non-sterile titanium, single use components.

#### Performance Data:

Finite Element Analysis, Custom Shear Testing and Bench Top Validations were included to demonstrate the substantial equivalency of the Life Spine Hammertoe Correction System.

## Conclusion:

The information presented demonstrates the substantial equivalency of the Hammertoe Correction System.