Talon DistalFix Antegrade/Retrograde Femoral Nail

K152295 · Orthopedic Designs North America, Inc. · HSB · Nov 3, 2015 · Orthopedic

Device Facts

• Record ID: K152295
• Device Name: Talon DistalFix Antegrade/Retrograde Femoral Nail
• Applicant: Orthopedic Designs North America, Inc.
• Product Code: HSB · Orthopedic
• Decision Date: Nov 3, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3020
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Talon™ DistalFix™ Antegrade Femoral Nail's primary indications are for fixation/stabilization of stable and unstable fractures of the femur including: - · Femoral shaft fractures - · Ipsilateral femur fractures - · Supracondylar fractures, including those with intra-articular extension - · Osteoporotic fractures - · Pathologic/impending pathologic fractures - · Malunions/nonunions The device is intended to stabilize fragments of the fracture until bony union can occur.

Device Story

Talon™ DistalFix™ Antegrade/Retrograde Femoral Nail System provides intramedullary fixation for femoral fractures. System includes femoral nail with proximal portals for cortical locking screws and distal portals for deployable integral talons; distal talons provide internal fixation and are retractable for nail removal. Proximal fixation achieved via separate cortical locking screws or universal cortical locking screws. Proximal end cap prevents bony ingrowth and facilitates explantation. Device used in surgical settings by orthopedic surgeons. Implants stabilize fracture fragments until bony union occurs. Manufactured from implant-grade titanium alloy.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Implant-grade titanium alloy construction. Intramedullary fixation rod with deployable integral distal talons and proximal cortical locking screws. Antegrade or retrograde surgical approach. Provided pre-assembled with distal talons and end cap.

Indications for Use

Indicated for fixation/stabilization of stable and unstable femoral fractures, including shaft, ipsilateral, supracondylar (with/without intra-articular extension), osteoporotic, pathologic/impending pathologic, and malunions/nonunions in patients requiring intramedullary stabilization.

Regulatory Classification

Identification

An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.

Predicate Devices

• Stryker® T2 Femoral Nail System (K112059, K081152, K021744)

Submission Summary (Full Text)

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

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "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, overlapping each other to create a sense of depth and unity.

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

Orthopedic Designs North America, Incorporated Robin Wilson Quality Manager 5912 Breckenridge Parkway, Suite F Tampa, Florida 33610

November 3, 2015

Re: K152295

Trade/Device Name: Talon™ DistalFix™ Antegrade/Retrograde Femoral Nail System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: August 12, 2015 Received: August 17, 2015

Dear Robin Wilson:

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

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

Page 2 – Robin Wilson

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 vours.

## Mark N. Melkerson -S

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

Enclosure

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

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

## Indications for Use

510(k) Number (if known) K152295

Device Name

Talon™ DistalFixTM Antegrade/Retrograde Femoral Nail System

Indications for Use (Describe)

The Talon™ DistalFix™ Antegrade Femoral Nail's primary indications are for fixation/stabilization of stable and unstable fractures of the femur including:

- · Femoral shaft fractures
- · Ipsilateral femur fractures
- · Supracondylar fractures, including those with intra-articular extension
- · Osteoporotic fractures
- · Pathologic/impending pathologic fractures
- · Malunions/nonunions

The device is intended to stabilize fragments of the fracture until bony union can occur.

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)

#### 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."

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

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

# SECTION 5: 510(k) SUMMARY

Image /page/3/Picture/2 description: The image shows the logo for Orthopedic Designs North America, Inc. The logo consists of a stylized "i" inside of a circle, followed by the letters "ODI" in a larger font. Below the letters "ODI" are the words "ORTHOPEDIC DESIGNS" and "NORTH AMERICA, INC." in a smaller font.

Date of Preparation:

October 21, 2015

#### Company Name / Contact:

Company: Orthopedic Designs North America, Inc. (ODi-NA) 5912 Breckenridge Parkway Suite F Tampa, FL 33610

Contact:

Robin Wilson Phone: [phone] Fax: [phone]

## Device Identification:

Talon™ DistalFix™ Antegrade/Retrograde Proprietary Name: Femoral Nail Common Used Name: Femoral Nail Classification Name: Rod. Fixation, Intramedullary and Accessories Classification Reference: 21 CFR § 888.3020 Classification Panel: 87 - Orthopedic Devices Device Product Code: HSB Proposed Regulatory Class: Class II

## Device Description:

The Talon™ DistalFix™ Antegrade/Retrograde Femoral Nail is used for fixation and stabilization of fractures of the femur until bony union can occur. The Talon™ DistalFix™ Antegrade/Retrograde Femoral Nail may be inserted into the femoral canal using either an antegrade or retrograde surgical approach. The system consists of the following parts:

- A femoral nail with proximal portals for passage of cortical locking screws 9 and distal portals that allow passage of deployable integral talons to achieve distal fixation from within the intramedullary canal. The distal talons may be retracted for removal of the intramedullary nail if and when it is necessary. The nail will be provided in a pre-assembled condition with the deployable distal nail talons and distal end cap already installed.

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

- Cortical locking screws will be provided separately. The cortical locking . screws are provided for proximal fixation if desired.
- Universal cortical locking screws will be provided separately. 0 The universal cortical locking screws provide increased purchase in cancellous bone and are provided for proximal fixation if desired.
- . A proximal end cap will be provided separately. The end cap prevents bony ingrowth and preserves the threads which may be used for attachment of instrumentation during explantation of the nail.

ODi-NA will manufacture the implants from implant grade titanium alloy.

#### Indications for Use:

The Talon ™ DistalFix ™ Antegrade/Retrograde Femoral Nail's primary indications are for fixation/stabilization of stable and unstable fractures of the femur including: femoral shaft fractures; ipsilateral femur fractures; supracondylar fractures, including those with intra-articular extension: osteoporotic fractures; pathologic/impending pathologic fractures; and malunions/nonunions. The device is intended to stabilize fragments of the fracture until bony union can occur.

#### Substantial Equivalence Information:

Orthopedic Designs North America, Inc. believes the Talon™ DistalFix™M Antegrade/Retrograde Femoral Nail is substantially equivalent to the products described herein with respect to indications for use, device design, materials, method of manufacture and method of sterilization. Within the proposed class, the following device is used as a predicate device for comparison: Stryker® T2 Femoral Nail System (K112059, K081152, K021744).

#### Mechanical Data:

Review of the mechanical test data indicates the Talon TM DistalFix TM Antegrade/Retrograde Femoral Nail is substantially equivalent to the previously cleared Stryker® T2 Femoral Nail System (K112059, K081152, K021744).