Hammertoe Correction System

K171448 · Life Spine, Inc. · HWC · Jul 7, 2017 · Orthopedic

Device Facts

• Record ID: K171448
• Device Name: Hammertoe Correction System
• Applicant: Life Spine, Inc.
• Product Code: HWC · Orthopedic
• Decision Date: Jul 7, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

The Hammertoe Correction System is an intramedullary bone screw implant used for the surgical correction of hammertoe deformities. The device features a dual-threaded design fabricated from titanium (Ti 6Al-4V ELI). During surgery, the implant is inserted into the phalangeal canal between the proximal and middle phalanges; the opposing threads provide fixation and compress the joint to facilitate fusion. The device is intended for single-use only and is utilized by orthopedic or podiatric surgeons in a clinical or hospital setting. By providing stable internal fixation, the implant promotes bone fusion, thereby correcting the toe deformity and improving patient function.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by bench testing, including finite element analysis, engineering rationale, and mechanical testing (torsional strength, bending strength, axial pullout, and driving torque), alongside bacterial endotoxin testing.

Technological Characteristics

Dual-threaded intramedullary bone screw; material: Titanium (Ti 6Al-4V ELI) per ASTM F136; single-use; sterile or non-sterile; mechanical fixation via compression of phalangeal joint.

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

• Hammertoe Correction System (K153065)
• Extremity HammerFiX (K152710)
• Arthrex BioPin (K050259)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/2 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with the profiles overlapping each other.

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

July 7, 2017

Life Spine, Inc. Randy Lewis General Manger 13951 S Quality Drive Huntley, Illinois 60142

Re: K171448

Trade/Device Name: 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 16, 2017 Received: May 17, 2017

Dear Randy 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 Part 801); medical device reporting (reporting of medical device

{1}------------------------------------------------

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" (21 CFR 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,

# Vincent J. Devlin -S

for

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

Enclosure

{2}------------------------------------------------

## Indications for Use

510(k) Number (if known) K171448

Device Name Hammertoe Correction System

#### Indications for Use (Describe)

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

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------------------------------------------------------------------|--|
| <div style="display:flex; align-items:center;"><span style="font-size: 20px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D)</div> | |
| <div style="display:flex; align-items:center;"><span style="font-size: 20px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C)</div> | |

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

## 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: | July 6th, 2017 |
| Trade Name: | Hammertoe Correction System |
| Common Name: | Intramedullary Bone Screw |
| Regulation Name: | Smooth or Threaded Metallic Bone Fixation Fastener |
| Classification: | HWC, CFR 888.3040, Class II |
| Primary Predicate: | Hammertoe Correction System (K153065) |
| Secondary Predicate: | Extremity HammerFiX (K152710)<br>Arthrex BioPin (K050259) |

## Device Description:

The Life Spine Hammertoe Correction System is an implant with a 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 the following:

- 1) 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 implants should never be reused under any circumstances.

{4}------------------------------------------------

#### 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 either sterile or non-sterile titanium, single use implants.

#### Performance Data:

Finite Element Analysis, Engineering Rationale, Bench Top Validations and Bacterial Endotoxin Testing (BET) were included to demonstrate the substantial equivalency of the Hammertoe Correction System with respect to: torsional strength, bending strength, axial pullout, and driving torque.

#### Conclusion:

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