ODI TALON LONG PROXIMAL FEMORAL NAIL SYSTEM

K033286 · Orthopedic Designs, Inc. (Odi) · HSB · Jan 12, 2004 · Orthopedic

Device Facts

• Record ID: K033286
• Device Name: ODI TALON LONG PROXIMAL FEMORAL NAIL SYSTEM
• Applicant: Orthopedic Designs, Inc. (Odi)
• Product Code: HSB · Orthopedic
• Decision Date: Jan 12, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3020
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ODi TALON™ Long Proximal Femoral Nail's primary indications are for fixation/stabilization of stable and unstable fractures of the proximal femur including intertrochanteric fractures, pertrochanteric fractures, subtrochanteric fractures, and combinations of these fractures. The device is intended to stabilize fragments of the fracture until bony union can occur.

Device Story

ODi TALON™ Long Proximal Femoral Nail system provides internal fixation for proximal femur fractures. System includes intramedullary nail, lag screw with deployable/retractable tangs for enhanced purchase, slotted sleeve, sleeve lock, compression screw, and distal cortical screws. Device components are pre-assembled to reduce surgical time. Surgeon inserts nail into femoral canal; lag screw assembly provides rotational stability via keyed shaft; compression screw draws fracture fragments together. Distal cortical screws cross-lock nail to femoral shaft to prevent rotation/axial translation. End cap protects internal threads from bony ingrowth. Used in clinical/surgical settings by orthopedic surgeons to stabilize fractures until bony union. Benefits include improved mechanical purchase in femoral head/neck and simplified surgical workflow through pre-assembly.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on design, material, and technological similarities to legally marketed predicate devices.

Technological Characteristics

Implant-grade stainless steel construction. Intramedullary fixation rod system. Features include deployable tang lag screw, sleeve lock mechanism (locked/unlocked positions), and compression screw. Dimensions/form factor designed for proximal femoral anatomy. Mechanical fixation principle. Non-electronic, non-software device.

Indications for Use

Indicated for fixation/stabilization of stable and unstable proximal femur fractures (intertrochanteric, pertrochanteric, subtrochanteric, and combinations) in patients requiring fracture stabilization until bony union. Contraindicated in patients with active local infection, metal sensitivity/allergy, insufficient bone stock/quality, or obliterated medullary canal.

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

• Smith & Nephew Richards - Intramedullary Hip Screw (K895241, K912162, K921786, K954712)
• Howmedica - Gamma Locking Nail System (K893639, K972813, K944883)
• Orthopedic Designs - TALON™ Intramedullary Hip Nail (K014189)

Reference Devices

• ODi TALON™ Compression Hip Screw (K984331)

Submission Summary (Full Text)

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

K033286

Page 1 of 3

## SECTION 12: 510(k) SUMMARY

Image /page/0/Picture/3 description: The image shows the logo for ODI Orthopedic Designs, Inc. The logo features a stylized "i" inside a circle, followed by the letters "ODI" in bold, sans-serif font. Below "ODI" is the text "ORTHOPEDIC DESIGNS, INC." in a smaller font size.

# Premarket Notification

510(k) Summary of Safety and Effectiveness Information

For Release Upon Request Only

October 6, 2003 Date of Preparation:

#### Regulatory Authority:

Safe Medical Devices Act of 1990, 21 CFR 807.92

### Company Name / Contact:

| Company: | Orthopedic Designs, Inc. (ODi)<br>9521 International Court North<br>St. Petersburg, FL 33716 |
|----------|----------------------------------------------------------------------------------------------|
|----------|----------------------------------------------------------------------------------------------|

- John Sodeika Contact: [phone]
#### Establishment Registration Number: 1064129

| Classification Name: | Rod, Fixation, Intramedullary and<br>Accessories, Metallic |
|----------------------------|------------------------------------------------------------|
| Classification Reference: | 21 CFR § 888.3020 |
| Common Used Name: | Femoral Nail |
| Device Product Code: | HSB |
| Classification Panel: | 87- Orthopedic Devices |
| Trade Proprietary Name: | ODi Talon™ Intramedullary Hip Nail |
| Proposed Regulatory Class: | Class II |

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

Kc 33286

Page 2 of 3

#### Device Description:

The ODi TALON™ Long Proximal Femoral Nail is used for fixation and stabilization of fractures of the proximal femur until bony union can occur. The system consists of the following parts:

- A femoral nail with portals that allow passage of distal cortical screws and a . proximal lag screw assembly. The nail will be provided in a pre-assembled condition with the sleeve lock and end cap already attached to save time in surgery.
- The TALON™ Lag Screw used in the nail system is completely compatible with . ODi's TALON™ Compression Hip Screw system and has been previously approved by the FDA in K984331. The TALON™ lag screw has deployable tangs to increase the purchase of the lag screw within the femoral neck/head. These tangs may also be retracted for removal of the lag screw if and when it is necessary. The distal end of the lag screw is keyed with a "double-d" shape, cannulated and internally threaded. This keyed shaft provides rotational stability for better lag screw purchase. The screw is internally threaded to allow the use of the compression screw to compress the fracture fragments.
- A slotted sleeve which passes through the intramedullary nail. The sleeve is . keyed to the lag screw assembly to prevent its rotation while allowing axial translation of the lag screw.
- A sleeve lock which passes through the proximal end inner bore of the . intramedullary nail. The sleeve lock has 2 positions within the intramedullary nail - "locked" and "unlocked". In the "locked" position, the legs on the sleeve lock mate with the slots in the sleeve thereby preventing rotation and axial translation of the sleeve, but allowing axial translation of the lag screw assembly. The sleeve lock is provided for surgery pre-assembled in the "unlocked" position within the intramedullary nail.
- A compression screw which shoulders against the slotted sleeve and engages . the internal threads in the distal end of the lag screw assembly providing for axial compression of a proximal hip fracture. The compression screw is used to compress the fracture site by drawing the nail and lag screw portions together. The cortical screws have been previously approved by the FDA in K984331.
- An end cap with both internal and external threads and a keying slot. The . external threads engage the internal threads in the proximal end of the intramedullary nail and protect them from bony ingrowth for the possible future attachment of nail removal instrumentation for explantation. The internal threads in the end cap mate with the nail installation instrumentation. The end cap is provided for surgery pre-assembled in the intramedullary nail.
- Cortical screws are provided to cross-lock the distal end of the nail to the . femoral shaft to help prevent axial translation or rotation of the nail. The cortical screws have been previously approved by the FDA in K984331.

The nail will be provided in a pre-assembled condition with the sleeve lock and end cap already attached to save time in surgery.

ODi will manufacture the implants from implant grade stainless steels.

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

KC3 3286
Page 3 of 3

#### Indications for Use:

The ODi TALON™ Long Proximal Femoral Nail will be used on indications that are common with presently marketed intramedullary hip nail systems. The primary indications are for fixation/stabilization of stable and unstable fractures of the proximal femur including intertrochanteric fractures, pertrochanteric fractures, subtrochanteric fractures, and combinations of these fractures. The device is intended to stabilize fragments of the fracture until bony union can occur.

#### Contra-indications for Use:

The ODi TALON™ Long Proximal Femoral is not intended for use in patients with the following conditions:

- Active local Infection. 1 -
- Metal sensitivity or allergic reaction to foreign bodies. 2.
- Loss of bone stock or insufficient bone quality to support the device. 3.
- Obliterated medullary canal. 4.

#### Substantial Equivalent Devices:

Orthopedic Designs, Inc. believes the ODi TALON™ Long Proximal 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 devices are used as predicate devices for comparison:

| Smith & Nephew Richards - Intramedullary Hip Screw | (K895241, K912162,<br>K921786, K954712) |
|-----------------------------------------------------|-----------------------------------------|
| Howmedica - Gamma Locking Nail System | (K893639, K972813,<br>K944883) |
| Orthopedic Designs - TALON™ Intramedullary Hip Nail | (K014189) |

Orthopedic Designs - TAL.ON™ Compression Hip Screw (K984331)

Each of these products is commercially available and are marketed Class II devices indicated for similar use.

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

Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle. The seal is black and white and has a simple, clean design.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

'JAN 1 2 2004

Mr. John Sodeika Vice President of Engineering Operations Orthopedic Designs, Inc. 9521 International Court N St. Petersburg, Florida 33716

Re: K033286

K033200
Trade/Device Name: ODi TALON™ Long Proximal Femoral Nail System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: HSB Dated: ()ctober 7, 2003 Received: October 14, 2003

Dear Mr. Sodeika:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave rollows 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 for use stated in the encreations of the enactment date of the Medical Device Amendments. or (o commerce processified 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). and Cosmette Prevy recepted, subject to the general controls provisions of the Act. The I ou may, merely, mains of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into cither class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can may be subject to back as base 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 or any I with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

Page 2 - Mr. John Sodcika

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis lower with and wyour he FDA finding of substantial equivalence of your device to a legally premance noticate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please if you desire spoente arroover you [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Marke M. Wilkinson

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

# SECTION 5: DEVICE INDICATIONS FOR USE

Page 1 of 1

Kon 2286 510(k) Number:

ODi TALON™ Long Proximal Femoral Nail System Device Name:

#### Indications For Use:

The ODi TALON™ Long Proximal Femoral Nail's primary indications are for The ODT TALON - Eong Proximal Practures of the proximal femur including intertrochanteric fractures, pertrochanteric fractures, subtrochanteric fractures, and intentroonantons of these fractures. The device is intended to stabilize fragments of the fracture until bony union can occur.

#### Contra-Indications:

The ODi TALON™ Long Proximal Femoral Nail is not intended for use in patients with the following conditions:

- 1. Active local Infection.
- 2. Metal sensitivity or allergic reaction to foreign bodies.
- 3. Loss of bone stock or insufficient bone quality to support the device.
- 4. Obliterated medullary canal.

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

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (per 21 CFR 801.109)

Over-The-Counter --OR

Mark N. Mulhesson
for

Crative

(Optional Format 1-2-96)

K033286 5-1