OLECRANAIL INTRAMEDULLARY FIXATION SYSTEM

K090091 · Mylad Orthopedic Solutions, LLC · HSB · Feb 1, 2009 · Orthopedic

Device Facts

• Record ID: K090091
• Device Name: OLECRANAIL INTRAMEDULLARY FIXATION SYSTEM
• Applicant: Mylad Orthopedic Solutions, LLC
• Product Code: HSB · Orthopedic
• Decision Date: Feb 1, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3020
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

This device is intended for the surgical fixation of all fractures and surgical osteotomies of the proximal ulna in the acute or chronic settings.

Device Story

OlecraNail Intramedullary Fixation System consists of solid-bore, tapered, stainless steel rod; designed for insertion into pre-drilled medullary canal of proximal ulna. System includes carbon fiber composite guide for drilling and screw insertion to secure bone fragments and lock rod. Manual compression mechanism allows fracture site compression. Guide features break-away detachment mechanism. Used by surgeons in clinical/OR settings for orthopedic fracture repair. Device provides mechanical stabilization of bone segments to facilitate healing.

Clinical Evidence

Bench testing only; no clinical data provided. Device performance verified through mechanical testing to ensure capability of withstanding expected in vivo loading.

Technological Characteristics

Solid-bore tapered rod; materials include stainless steel, carbon fiber composite, 17-6 Condition H-900, and titanium 6-4 alloy. Materials inspected and certified to meet ASTM standards. Mechanical fixation via intramedullary rod and screws with manual compression mechanism.

Indications for Use

Indicated for surgical fixation of all fractures and surgical osteotomies of the proximal ulna in acute or chronic settings.

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

• OlecraNail™ Intramedullary Fixation Device (K081356)
• Smith and & Nephew TriGen Meta-Nail Retrograde Femoral and Tibial Nails (K061019)
• Hand Innovations Distal Volar Radius Fracture Repair System (K002775)

Submission Summary (Full Text)

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# Attachment 8

## FEB 1 1 2009

## 510 (k) Summary

#### Submitter's Name and Address

Contact Person

Date of Summary:

Proprietary Name of Device:

Common/Usual Name:

Classification Name:

Legally Marketed Equivalent Devices:

Mylad Orthopedic Solutions, LLC 8803 Windy Creek Way McLean, Virginia 22102 Phone: [phone] Facsimile: [phone]

Scott Edwards, M.D.

December 20, 2008

OlecraNail™ Intramedullary Fixation System

intramedullary nail

Rod, Fixation, Intramedullary and Accessories per 21 C.F.R. § 888.3020

OlecraNail™ Intramedullary Fixation Device (K081356) Smith and & Nephew TriGen Meta-Nail Retrograde Femoral and Tibial Nails (K061019) Hand Innovations Distal Volar Radius. Fracture Repair System (K002775)

#### Summary of Device:

The OlecraNail™ intramedullary rod is a solid bore, stainless steel, tapered rod that is inserted into a pre-drilled hole into the medullary canal of the proximal ulna. Once the device is in place, a carbon fiber composite guide is used to drill into the bone and insert several screws through the bone and rod to secure all bone fragments and lock the rod into position. During this process, compression at the fracture site may be obtained by manually turning a knob to activate the compression mechanism. After all screws are placed, the guide may then be detached using a break-away mechanism.

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#### Intended Use:

This device is intended for the surgical fixation of all fractures and surgical osteotomies of the proximal ulna in the acute or chronic settings. No changes have occurred to the Intended Use from the previously cleared device. the OlecraNail Intramedullary Fixation System (K081356).

#### Technological Characteristics of the Device Compared to the Predicate Devices:

The principle of operation of the subject devices is identical to that of the predicates. There are no changes in intended use, performance specifications or method of operation. A review of the test data for the subject devices indicates that they are equivalent to the predicate devices currently in clinical use and are capable of withstanding expected in vivo loading without failure.

Substantial equivalence for the OlecraNail™ Intramedullary Fixation System is based on their similarities in indications for use, design features, operational principles, and material composition when compared to the predicate devices cleared under the following submissions: Olecranail™ Intramedullary Fixation System (K081356), Smith & Nephew TriGen Meta-Nail Retrograde Femoral and Tibial Nails (K061019), and Hand Innovations Distal Volar Radius Fracture Repair System (K002775).

#### Miscellaneous Information:

Carbon fiber composite material, 17-6 Condition H-900, titanium 6-4 alloy are supplied, inspected, and certified to meet ASTM standards.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol of medicine, with three intertwined snakes wrapped around a staff with wings at the top. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus. The logo is black and white.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## FEB 1 1 2009

Mylad Orthopedic Solutions, LLC % Scott G. Edwards, M.D. President 8803 Windy Creek Way McLean, Virginia 22102

Re: K090091

Trade/Device Name: OlecraNail IM Intramedullary Fixation System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulation Class: Class II Product Code: HSB Dated: January 13, 2009 Received: January 14, 2009

Dear Dr. Edwards:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

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Page 2 - Scott G. Edwards, M.D.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate 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 contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrh/industry/support/index.html.

Sincerely yours,

Mark A. Milken

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

Enclosure

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# Attachment 2

## Indications for Use Statement

510(k) K090091 Number (if known) OlecraNailTM Intramedullary Fixation System Device Name The OlecraNail™ Intramedullary Fixation System and accessories are Indications for Use intended for the surgical fixation of all fractures and surgical · osteotomies of the proximal ulna in the acute or chronic setting.

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

### Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X (Per 21 CFR 801. 109)

OR

Over-The-Counter Use

Sonata

(Division Sign-Oil) Division of Surgic ), Orthopedic, and Restorative Devices

510(k) Number K090091

LEGAL02/31014278v1