MAGNUM NAIL

K093089 · Robert Reid, Inc. · HSB · Nov 13, 2009 · Orthopedic

Device Facts

• Record ID: K093089
• Device Name: MAGNUM NAIL
• Applicant: Robert Reid, Inc.
• Product Code: HSB · Orthopedic
• Decision Date: Nov 13, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3020
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Magnum Nail is intended for use in fixation of stable and unstable fractures of the proximal femur. The types of proximal femoral fractures include pertrochanteric, intertrochanteric, basal neck fractures, high subtrochanteric fractures and combinations of these fractures. The Magnum Nail is also indicated for use in osteotomy, nonunions and malunions, bone reconstruction following tumor resection, grafting and pathological fractures and revision procedures.

Device Story

Intramedullary fixation system for proximal femur; components include nails, distal bone screws, cannulated lag screws, cannulated blades, and set screws. Used by orthopedic surgeons in clinical settings for fracture stabilization and bone reconstruction. Device provides mechanical support to bone segments to facilitate healing. System design and mechanical performance are equivalent to existing predicate nailing systems.

Clinical Evidence

No clinical data provided; substantial equivalence supported by design and mechanical performance documentation.

Technological Characteristics

Intramedullary fixation rod system. Materials: Titanium alloy (Ti-6Al-4V) per ASTM F136. Components include nails, distal bone screws, cannulated lag screws, cannulated blades, and set screws in various sizes.

Indications for Use

Indicated for patients requiring fixation of stable and unstable proximal femoral fractures, including pertrochanteric, intertrochanteric, basal neck, and high subtrochanteric fractures. Also indicated for osteotomy, nonunions, malunions, bone reconstruction post-tumor resection, grafting, pathological fractures, and revision procedures.

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

• Fixion™ Interlocking Proximal Femoral Nailing System (K010988)
• Trochanteric Fixation Nail System (K011857)

Submission Summary (Full Text)

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NOV 1 8 2009

| | NOV 18 2009 |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 8. 510(k) Summary | |
| Sponsor: | Robert Reid Inc.<br>4-22-2, Koishikawa, Bunkyo-ku<br>Tokyo 112-0002 Japan<br>Phone [phone]<br>Fax [phone] |
| Contact Person: | Teiji Nakamura, Marketing Director |
| Proposed Trade Name: | Magnum Nail |
| Device Classification | Class II |
| Classification Name: | Rod, fixation, intramedullary and accessories |
| Regulation: | 888.3020 |
| Device Product Code: | HSB |
| Device Description: | The Magnum Nail consists of nails, distal bone screws, cannulated lag<br>screws, cannulated blades and set screws in a variety of sizes to<br>accommodate differing anatomic requirements. |
| Intended Use: | The Magnum Nail is intended for use in fixation of stable and unstable<br>fractures of the proximal femur. The types of proximal femoral fractures<br>include pertrochanteric, intertrochanteric, basal neck fractures, high<br>subtrochanteric fractures and combinations of these fractures. The Magnum<br>Nail is also indicated for use in osteotomy, nonunions and malunions, bone<br>reconstruction following tumor resection, grafting and pathological<br>fractures and revision procedures. |
| Materials: | The Magnum Nail components are manufactured from titanium alloy (Ti-<br>6Al-4V) as described by ASTM F136. |
| Substantial<br>Equivalence: | Documentation was provided which demonstrated the Magnum Nail to be<br>substantially equivalent to previously cleared devices (Fixion™<br>Interlocking Proximal Femoral Nailing System, K010988 and Trochanteric<br>Fixation Nail System, K011857). The substantial equivalence is based upon<br>equivalence in basic design, intended use, indications, anatomic sites and<br>mechanical performance. |

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name in a circular arrangement around the perimeter. In the center is a stylized emblem that resembles a caduceus, a symbol often associated with medicine and healthcare. The emblem is composed of a series of curved lines that form a wing-like shape.

## Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

## NOV 1 3 2009

Robert Reid Inc. % Karen E. Warden, Ph. D. Consultant 8202 Sherman Road Chesterland, Ohio 44026-2141

Re: K093089

Trade/Device Name: Magnum Nail Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: September 28, 2009 Received: October 1, 2009

Dear Dr. Warden:

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 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Karen E. Warden, Ph.D.

forth in the quality systems (OS) 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/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/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/ResourcesforYou/Industry/default.htm.

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Sincerely yours,

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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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## 7. Indications for Use Statement

510(k) Number: K. 093080

Device Name: Magnum Nail

Indications for Use:

The Magnum Nail is intended for use in fixation of stable fractures of the proximal femur. The types of proximal fractures include pertrochanteric, intertrochanteric, basal neck fractures, high subtrochanteric fractures and combinations of these fractures. The Magnum Nail is also indicated for use in osteotomy, nonunions and malunions, bone reconstruction following tumor resection, grafting and pathological fractures and revision procedures.

Prescription Use X Over-the-Counter Use AND/OR (21 CFR 807 Subpart C) (21 CFR 801 Subpart D)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Danuta for mxn
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number. K093089

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