Footmotion HammerToe

K172485 · Newclip Technics · HTY · Mar 2, 2018 · Orthopedic

Device Facts

• Record ID: K172485
• Device Name: Footmotion HammerToe
• Applicant: Newclip Technics
• Product Code: HTY · Orthopedic
• Decision Date: Mar 2, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The implants of the Footmotion Hammer Toe range are intended for proximal interphalangeal arthrodeses of lesser toes in adults.

Device Story

Footmotion HammerToe is an intramedullary implant system designed for proximal interphalangeal arthrodesis of lesser toes. The device is used by orthopedic surgeons in a clinical or surgical setting to correct hammertoe deformities. The implant is inserted into the intramedullary canal of the toe to provide bone fixation and facilitate fusion. The device is provided either non-sterile for facility-based sterilization or pre-sterilized via gamma radiation. By stabilizing the joint, the implant promotes arthrodesis, potentially reducing pain and restoring proper toe alignment for the patient.

Clinical Evidence

No clinical data. Bench testing only, including flexion and pull-out tests.

Technological Characteristics

Intramedullary bone fixation implant. Material: Titanium alloy Ti-6Al-4V ELI (ASTM F136-13, ISO 5832-3). Sterilization: Gamma radiation or facility-based sterilization. Mechanical fixation principle.

Indications for Use

Indicated for proximal interphalangeal arthrodeses of lesser toes in adults.

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

• Memometal Intra-medullary Bone Fastener (K070598 / K112197)
• Pro-Toe Vo Hammertoe Implant System (K101165)
• Nextra Ti Hammertoe Correction System (K122031)

Reference Devices

• Trim-it drill pin (K050259)

Submission Summary (Full Text)

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March 2, 2018

Newclip Technics % J.D. Webb Official Correspondent The OrthoMedix Group, Inc. 1001 Oakwood Boulevard Round Rock, Texas 78681

Re: K172485

Trade/Device Name: Footmotion HammerToe Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HTY Dated: February 16, 2018 Received: February 20, 2018

Dear Mr. Webb:

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

#### Indications for Use

510(k) Number (if known) K172485

Device Name

Footmotion HammerToe

Indications for Use (Describe)

The implants of the Footmotion Hammer Toe range are intended for proximal interphalangeal arthrodeses of lesser toes in adults.

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

> Prescription Use (Part 21 CFR 801 Subpart D)

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

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Image /page/3/Picture/1 description: The image is a logo for a company called "NEWCLIP-TECHNICS". The logo consists of the letters "nct" in a circle, with the "t" in a different color (reddish-pink) and an arrow pointing upwards. The company name is written in capital letters below the circle.

## 510 (k) Summary for the Footmotion HammerToe range

In accordance with 21 CFR 807.92 of the Federal Code of Regulations, the following 510(k) summary is submitted for the HammerToe system.

Summary preparation date: March, 2017

| 1. Submitter: | Contact Person: |
|----------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|
| NEWCLIP TECHNICS<br>P.A. de la Lande Saint Martin<br>45 rue des Garottières<br>F-44115 Haute-Goulaine -<br>France<br>Telephone: [phone] | J.D. Webb<br>The OrthoMedix Group, Inc.<br>1001 Oakwood Blvd<br>Round Rock, TX 78681<br>Telephone: [phone] |
| 2. Trade name: | Footmotion HammerToe |
| Common Name: | Smooth or threaded metallic bone<br>fixation fastener. |
| Product code: | HTY |
| Classification Name: | Smooth or threaded metallic bone<br>fixation fastener<br>(21 CFR part. 888.3040) |

### 3. Primary predicate or legally marketed devices which are substantially equivalent:

- Memometal Intra-medullary Bone Fastener of MEMOMETAL . TECHNOLOGIES (K070598 / K112197)
K112197 is a re-submission of K070598 after Memometal Smart Toe® intramedullary bone fastener line extension.

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Image /page/4/Picture/1 description: The image shows the logo for NEWCLIP-TECHNICS. The logo features the letters "nct" in a circle, with the "t" having an upward-pointing arrow as part of its design. Below the circle, the words "NEWCLIP - TECHNICS" are written in a sans-serif font.

#### Secondary predicate or legally marketed devices which are substantially equivalent:

- Pro-Toe Vo Hammertoe Implant System of WRIGHT MEDICAL . TECHNOLOGIES (K101165)
- Nextra Ti Hammertoe Correction System of NEXTREMITY . SOLUTION, INC (K122031)

#### Reference predicate or legally marketed devices which are substantially equivalent:

- Trim-it drill pin of ARTHREX (K050259) .
- 4. Description of the device: The Footmotion HammerToe range consists of intramedullary implants designed for proximal interphalangeal arthrodeses of lesser toes in adults.

The Footmotion HammerToe range will be provided non sterile for health sterilization bv care professionals prior to use or provided sterile by gamma sterilization.

- Materials: Titanium alloy Ti-6AI-4V ELI (conform to ASTM F136-13 and ISO 5832-3).
- Function: The implants of the Footmotion HammerToe range are intended for proximal interphalangeal arthrodeses of lesser toes in adults.

## 5. Substantial equivalence claimed to predicate devices:

The Footmotion HammerToe range is substantially equivalent to the predicate devices in terms of intended use, design, materials used, mechanical safety and performance.

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Image /page/5/Picture/1 description: The image shows a logo for a company called "NEWCLIP-TECHNICS". The logo features the letters "nct" inside of a circle. The "t" in "nct" has a red arrow pointing upwards. The company name is written in all caps below the circle.

### 6. Intended use:

The implants of the Footmotion HammerToe range are intended for proximal interphalangeal arthrodeses of lesser toes in adults.

### 7. Non-clinical Test Summary:

The following tests were conducted:

- Flexion tests .
- Pull out tests .

#### 8. Clinical Test Summary:

No clinical studies were performed.

#### 9. Conclusions Non-clinical and Clinical:

Newclip considers the Footmotion HammerToe range to be equivalent to the predicate devices listed above. This conclusion is based upon the device's similarities in principles of operation, technology, materials, and indications for use.