ES TROCHANTERIC NAIL, LEFT AND RIGHT, 10MM

K103533 · Advanced Orthopaedic Solutions, Inc. · HSB · Jan 19, 2011 · Orthopedic

Device Facts

• Record ID: K103533
• Device Name: ES TROCHANTERIC NAIL, LEFT AND RIGHT, 10MM
• Applicant: Advanced Orthopaedic Solutions, Inc.
• Product Code: HSB · Orthopedic
• Decision Date: Jan 19, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3020
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The AOS ES™ Trochanteric Nail is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric, intertrochanteric and high subtrochanteric fractures and combinations of these fractures.

Device Story

AOS ES™ Trochanteric Nail is a titanium intramedullary fixation device designed for proximal femur fracture stabilization. System components include intramedullary nail, sliding lag screw, anti-rotation screw, locking screws, and end cap. Device is inserted through greater trochanter. Used by orthopedic surgeons in clinical/surgical settings to provide mechanical fixation for fracture healing. Benefits include stabilization of stable/unstable proximal femoral fractures.

Clinical Evidence

Bench testing only. Evidence consists of bench bending analysis and dimensional comparison against the predicate device to confirm equivalent strength and geometry.

Technological Characteristics

Material: Titanium (ASTM F136). Components: Intramedullary nail, sliding lag screw, anti-rotation screw, locking screws, end cap. Design: Trochanteric entry intramedullary fixation rod.

Indications for Use

Indicated for patients with stable and unstable proximal femur fractures, including pertrochanteric, intertrochanteric, and high subtrochanteric fractures and combinations thereof.

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

• AOS Trochanteric Nail (K021008)

Submission Summary (Full Text)

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ADVANCED ORTHOPAEDIC SOLUTIONS

JAN 1 9 2011

K1035333

## 8. SPECIAL 510(K) SUMMARY

November 30, 2010

SUMMARY PREPARED ON:

SUBMITTED BY: Advanced Orthopaedic Solutions, Inc. 386 Beech Avenue, Unit B6 Torrance, CA 90501 · Phone: [phone]

HSB

2002)

CONTACT PERSON:

Julie Glendrange Advanced Orthopaedic Solutions, Inc. 386 Beech Avenue, Unit B6 Torrance, CA 90501 Phone: [phone]

Intramedullary Fixation Rod

AOS Extended Short (ES™) Trochanteric Nail

Class II. 21 CFR 888.3020 Intramedullary Fixation Rod

AOS Trochanteric Nail (K021008, Cleared June 20,

DEVICE NAME: COMMON NAME: CLASSIFICATION:

DEVICE CODE:

SUBSTANTIALLY EQUIVALENT DEVICE:

DEVICE DESCRIPTION:

INDICATIONS FOR USE:

The AOS ES™ Trochanteric Nail is a Titanium intramedullary nail that is designed to enter the femur through the greater trochanter. It consists of an intramedullary nail. sliding lag screw, anti-rotation screw, locking screws and end cap.

The AOS ES™ Trochanteric Nail is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric, intertrochanteric and high subtrochanteric fractures and combinations of these fractures.

Information presented supports substantial equivalence SUBSTANTIAL EQUIVALENCE: of the AOS ES™ Trochanteric Nail to the predicate device. The proposed nail has the same indications for use, is similar in geometry and design, has the same fundamental technology and is made of the same material (ASTM F136) as the predicate device. The ES Trochanteric Nail was tested against the predicate device through a bench bending analysis as well as a dimensional comparison. The testing resulted in substantial euqivent strength and geometry between the ES trochanteric nail and the short trochanteric nail.

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Image /page/1/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 often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the caduceus.

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

Advanced Orthopaedic Solutions, Inc. % Ms. Julie Glendrange 386 Beech Avenue, Unit B6 Torrance, CA 90501

JAN 1 9 2011

Re: K103533 Trade/Device Name: AOS ES Trochanteric Nail Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: HSB Dated: December 21, 2010 Received: December 22, 2010

Dear Ms. Glendrange:

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

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## Page 2 - Ms. Julie Glendrange

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 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 go to http://www.fda.gov/AboutlFDA/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/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/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Ais. 13. 12. +

fa-

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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## Indication for Use

510(k) Number (if known): K103533

Device Name: AOS Extended Short (ES™) Trochanteric Nail

Indications for Use:

The AOS ES™ Trochanteric Nail is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric, intertrochanteric and high subtrochanteric fractures and combinations of these fractures.

Prescription Use: X___ AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use: (Part 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)

for M. Melkerom
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K103533