HAMMER TOE IMPLANT

K122959 · Trilliant Surgical, Ltd. · HWC · Nov 7, 2012 · Orthopedic

Device Facts

• Record ID: K122959
• Device Name: HAMMER TOE IMPLANT
• Applicant: Trilliant Surgical, Ltd.
• Product Code: HWC · Orthopedic
• Decision Date: Nov 7, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Hammer Toe System implants are intended for fixation of osteotomies and reconstruction of the lesser phalanges during procedures to correct deformities of the lesser toes and fingers. Indications include: hammer toe deformity, claw toe deformity, mallet toe deformity, and other deformities of the foot and hand.

Device Story

Hammer Toe Implant is a cannulated, threaded, and spaded bone fixation device for phalanges of lesser digits in foot and hand. Device features self-tapping threaded section and proximal tri-spade configuration. Used by orthopedic surgeons in clinical settings for fixation of osteotomies and reconstruction of deformities. Implant delivered via K-wires; K-wires also used for temporary stabilization of outlying joints. Device provides mechanical stability to bone segments during healing process, facilitating correction of toe/finger deformities.

Clinical Evidence

No clinical data. Bench testing performed per ASTM F543, including static axial pull-out of threaded and barbed sections, driving torque, and failure torque testing in polyurethane foam blocks.

Technological Characteristics

Titanium alloy (ASTM F136). Cannulated, threaded, and tri-spaded design. Dimensions vary by diameter and length. Mechanical fixation via threaded and spade components. No software or electronic components.

Indications for Use

Indicated for patients requiring fixation of osteotomies and reconstruction of lesser phalanges to correct deformities of the lesser toes and fingers, including hammer toe, claw toe, and mallet toe deformities.

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

• DigiFuse™ (K111536)
• Tiger Cannulated Screws (K081510)

Reference Devices

• K-wires (K121008)

Submission Summary (Full Text)

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K12 2959 (pg. 1 of 2)

NOV 7 2012

# 510(k) Summary for the Trilliant Hammer Toe Implant

In accordance with 21 CFR 807.92 of the Federal Code of Regulations the following 510(k) summary is submitted for the Trilliant Hammer Toe Implant

#### 1. GENERAL INFORMATION

Date Prepared: September 18, 2012

Trade Name: Hammer Toe Implant

Classification

Name: Screw, Fixation, Bone

Class: II

Product Code: HWC

CFR section: 21 CFR section 888.3040

Device panel: Orthopedic

DigiFuse™ - K111536 Legally Marketed

Predicate Device: Tiger Cannulated Screws - K081510

> Submitter: Trilliant Surqical LTD 630 W.13th St Houston, TX 770081

Contact: J.D. Webb 1001 Oakwood Blvd Round Rock, TX 78681 512-388-0199 Tele 512-692-3699 Fax e-mail: [e-mail]

#### 2. DEVICE DESCRIPTION

The Hammer Toe Implant is a threaded/spaded device used for bone fixation in the phalanges of the lesser digits in the foot and hand. The implant, which is a cannulated, threaded and spaded device, is offered in multiple diameters and lengths. The system will also consist of K-wires (K121008) to be used in the delivery of the implant and also for use of temporary stabilization of outlying joints.

#### Change from Predicate:

Both the Hammer Toe Implant and the predicate Tiger Cannulated Screws have a self tapping threaded section and both are cannulated for use with K-wires. The thread dimensions are the same for both devices. Opposite the Tiger screws have a smooth section ending in a head. The Hammer Toe components have a tri-spade configuration at the proximal end.

### Materials:

Titanium alloy per ASTM F136

#### 3. SUBSTANTIAL EQUIVALENCE CLAIMED TO PREDICATE DEVICES

The Hammer Toe Implant is substantially equivalent to the predicate devices in terms of intended use, design, materials used, mechanical safety and performances.

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K122959 (pg. 2 of 2)

## 4. INTENDED USE

The Hammer Toe System implants are intended for fixation of osteotomies and reconstruction of the lesser phalanges during procedures to correct deformities of the lesser toes and finqers. Indications include: hammer toe deformity, claw toe deformity, mallet toe deformity, and other deformities of the foot and hand.

# 5. NON-CLINICAL TEST SUMMARY

Testing per ASTM F543 included:

- Static axial pull-out of threaded portion from polyurethane foam test block, .
- Static axial pull-out of barbed (spade) section from polyurethane foam test block, .
- Driving torque into polyurethane foam test block and .
- Static testing to determine failure torque .

The results of this testing indicate that the Hammer Toe System is equivalent to predicate devices.

#### CLINICAL TEST SUMMARY 6.

No clinical studies were performed

# 7. CONCLUSIONS NONCLINICAL AND CLINICAL

Trilliant Surgical considers the Hammer Toe System to the predicate device listed above. This conclusion is based upon the devices' similarities in principles of operation, technology, materials and indications for use

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

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Letter Dated: November 7, 2012

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

Trilliant Surgical LTD % J.D. Webb 1001 Oakwood Blvd. Round Rock, Texas 78681

Re: K122959

Trade/Device Name: Hammer Toe Implant Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: September18, 2012 Received: September 25, 2012

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

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Page 2 - Mr. Webb

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quarty of every of ovisions (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 n you uselle sport fila gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.html for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part note the regulation intineed on the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/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,

# Mark N. Melkerson

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): _ K122959

Device Name: Hammer Toe System

Indications for Use:

The Hammer Toe System implants are intended for fixation of osteotomies and reconstruction of the lesser phalanges during procedures to correct deformities of the lesser toes and fingers. Indications include: hammer toe deformity, claw toe deformity, mallet toe deformity, and other deformities of the foot and hand.

Prescription Use × (Part 21 CFR 801 Subpart D)

すると、その他、このミーニング・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Ahk

(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K122959