OLECRA INTRAMEDULLARY FIXATION SYSTEM

K110322 · Mylad Orthopedic Solutions · HSB · Mar 4, 2011 · Orthopedic

Device Facts

• Record ID: K110322
• Device Name: OLECRA INTRAMEDULLARY FIXATION SYSTEM
• Applicant: Mylad Orthopedic Solutions
• Product Code: HSB · Orthopedic
• Decision Date: Mar 4, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3020
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The OlecraNail® Intramedullary Fixation System and accessories are intended for the surgical fixation of all fractures and surgical osteotomies of the proximal ulna in the acute or chronic setting.

Device Story

OlecraNail® Intramedullary Fixation System is an orthopedic implant system for proximal ulna fracture fixation and osteotomies. Device consists of an intramedullary nail and surgical accessories. Accessories facilitate bone cutting, drill hole measurement, and nail removal. Used in surgical settings by orthopedic surgeons. System provides mechanical stabilization of bone segments to promote healing. Benefits include improved procedural efficiency for the surgeon during fixation and removal tasks.

Clinical Evidence

Human cadaveric testing was performed to validate the design of the accessories for the OlecraNail® Intramedullary Fixation System.

Technological Characteristics

Intramedullary fixation rod and associated surgical instrumentation. Design and materials are identical or similar to previously cleared predicate devices.

Indications for Use

Indicated for patients requiring surgical fixation of fractures or 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

• Acumed ulna shortening osteotomy guide (K063460)
• Biomet Premier Total Knee Instrumentation System (K090091)
• Acumed Congruent Bone Plate System (K090091)

Submission Summary (Full Text)

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K 110322(1/2)

MAR - 4 2011

# Section 3: 510(k) Summary

Submitter's Name and Address

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

OlecraNail® Intramedullary Fixation

Rod, Fixation, Intramedullary and

Accessories per 21 CFR section 888.3020

Acumed ulna shortening osteotomy guide

Biomet Premier Total Knee Instrumentation Acumed Congruent Bone Plate System

Mylad OlecraNail® Intramedullary Fixation

Scott Edwards, M.D.

January 20, 2011

Intramedullary nail

System

(K063460)

System (K090091)

Date of Summary:

Contact Person

Proprietary Name of Device:

Common/Usual Name:

Classification Name:

Legally Marketed Equivalent Devices:

### Summary of Device:

The OlecraNail® intramedullary nail is a fixation device that has been previously cleared for marketing (K090091). Accessories are being added to the system that will offer optional advantages in terms of how the procedure is accomplished, specifically how the bone is cut, the drill holes are measured, and how the nail is removed.

#### Intended Use:

The OlecraNail® Intramedullary Fixation System and accessories are intended for the surgical fixation of all fractures and surgical osteotomies of the proximal ulna in the acute or chronic setting.

Technological Characteristics of the Device Compared to the Predicate Devices: The material, design, and intended use of the accessories for the OlecraNail® I he macerial, 2017-11, are identical or similar to at least one of the listed predicates. There are no technological characteristics that raise new issues of safety or effectiveness.

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K11032(2/2)

# Non-Clinical Tests:

• ﺳﺮ

t

Human cadaveric testing validated the design of accessories for the OlecraNail® Intramedullary Fixation System. Details of these tests are included in this Special 510(k) application.

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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 depiction of an eagle or bird with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.

#### Public Health Service

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

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

MAR - 4 2011

Re: K110322

Trade/Device Name: OlecraNail® Intramedullary Fixation System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB, NDE Dated: January 24, 2011 Received: February 03, 2011

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. 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

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Page 2 - Scott Edwards, M.D.

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 forth in the quality systems (QS) regulation (21 CFR Part 820); and if anplicable, 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm 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 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm

Sincerely yours,

Aliz B. R.h

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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(P. 1 of 1)

| | Section 2: Statement of Indications for Use |
|-----------------|---------------------------------------------|
| 510(k) Number _ | K11 0322 |

OlecraNail® Intramedullary Fixation System Device Name:

## Indications for Use:

The OlecraNail® Intramedullary Fixation System and accessories are intended for the surgical fixation of all fractures and surgical osteotomies of the proximal ulna in the acute or chronic setting.

X Prescription Use __ (21 CFR 801 Subpart D) OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

M. Mucken

Division Orthopedic, .JUS

510(k) Number K110322. -9-