REVOLUTION FEMORAL INTRAMEDULLARY NAIL SYSTEM, MODEL DGOOXX

K091309 · Dgimed Ortho, Inc. · HSB · Nov 5, 2009 · Orthopedic

Device Facts

• Record ID: K091309
• Device Name: REVOLUTION FEMORAL INTRAMEDULLARY NAIL SYSTEM, MODEL DGOOXX
• Applicant: Dgimed Ortho, Inc.
• Product Code: HSB · Orthopedic
• Decision Date: Nov 5, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3020
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Revolution Femoral Intramedullary Nail System is indicated for use in orthopaedic intramedullary nailing procedures: midline femoral fractures, femoral fractures in multiple trauma patients, fractures in the morbidly obese patient, fractures in osteoporotic bone or malunions and nonunions.

Device Story

Revolution Femoral Intramedullary Nail System is a closed-section, cannulated, thick-walled, mirror-finished, curved intramedullary fixation device; includes locking screws for proximal and distal fixation. Used in orthopedic surgery to stabilize femoral fractures; reduces shortening and rotation. Ancillary instrumentation provided for canal access, bone preparation, nail/screw installation, and removal. Operated by orthopedic surgeons in clinical/OR settings. Provides mechanical stabilization of bone segments to facilitate healing.

Clinical Evidence

No clinical data. Safety and performance substantiated through non-clinical bench testing.

Technological Characteristics

Closed-section, cannulated, thick-walled, mirror-finished, curved intramedullary nail; includes locking screws. Materials and design are consistent with standard orthopedic intramedullary fixation rods.

Indications for Use

Indicated for patients requiring orthopedic intramedullary nailing for midline femoral fractures, femoral fractures in multiple trauma, fractures in morbidly obese patients, fractures in osteoporotic bone, or malunions and nonunions.

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

• Russell-Taylor Femoral Nail (K893377)
• Cannulated Retrograde/Antegrade Femoral Nail EXPERT System (K033618)
• T2 Femoral Nailing System (K912930)

Submission Summary (Full Text)

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iC091309

# DGIMed Ortho, Inc. Traditional 510(k) Premarket Notification: Revolution Femoral Intramedullary Nail

## 510(K) SUMMARY AS REQUIRED BY 21 CFR 807.92 6

| 510(k) Number | Not yet assigned | |
|-----------------------|----------------------------------------------------------------------------------|--------------|
| Date Prepared | May 1, 2009 | NOV - 5 2009 |
| Submitter Information | DGIMed Ortho, Inc.<br>12400 Whitewater Drive, Suite 2010<br>Minnetonka, MN 55343 | |
| Contact Person: | Scott P. Youngstrom<br>VP, Finance & COO<br>phone: [phone] | |
| Device Information | | |
| Trade Name: | Revolution Femoral Intramedullary Nail System | |
| Common Name: | Intramedullary Fixation Rod and Accessories | |
| Classification: | Class II | |
| Product Code: | HSB | |
| Regulation: | 21 CFR 888.3020 | |
| Panel: | 87 - Orthopedic | |

## Predicate Devices

| Device | Manufacturer | 510(k) Status |
|---------------------------------------------------------------|----------------|---------------|
| Russell-Taylor Femoral Nail | Smith & Nephew | K893377 |
| Cannulated Retrograde/Antegrade<br>Femoral Nail EXPERT System | Synthes | K033618 |
| T2 Femoral Nailing System | Stryker Corp. | K912930 |

#### Device Description 6.1

The Revolution Femoral Intramedullary Nail System permits an antegrade intramedullary approach for fixation of fractures of the femur. The Revolution Femoral Intramedullary Nail is a closed section, cannulated, thick walled, mirror finished, curved intramedullary fixation device containing two proximal and two distal holes to accept locking screws which thread transversely though the proximal and distal third of the femur. The Nail is available in a variety of diameters and lengths.

Locking screws are also included as a component of the Nail system. The locking screws are designed to reduce the likelihood of shortening and rotation of femoral fractures. The locking screws are available in a single diameter and a variety of lengths.

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## DGIMed Ortho, Inc. Traditional 510(k) Premarket Notification: Revolution Femoral Intramedullary Nail

The ancillary instrumentation include standard orthopedic instruments for accessing the femoral medullary canal, preparing the bone for placement and installation of the intramedullary nail and locking screws, and removal of the intramedullary nail and screws, if required..

#### 6.2 Intended Use

The Revolution Femoral Intramedullary Nail System is indicated for use in orthopedic intramedullary nailing procedures: midline femoral fractures, femoral fractures in multiple trauma patients, fractures in the morbidly obese patient, fractures in osteoporotic bone or malunions and nonunions.

#### 6.3 Summary of Non-clinical Testing

The safety and performance of the Revolution Femoral Intramedullary Nail System have been substantiated through non-clinical testing. Results of testing confirm that the Revolution Femoral Intramedullary Nail System reliably performs as intended. No new questions of safety or effectiveness have been raised.

#### 6.4 Substantial Equivalence

The Revolution Femoral Intramedullary Nail System's product information, technological comparison to predicate products, and test results demonstrate that the Revolution Femoral Intramedullary Nail System is safe and performs as intended. Any differences in technological features raise no new questions of safety or effectiveness. Revolution Femoral Intramedullary Nail System is substantially equivalent to the currently marketed predicate devices with respect to intended use, materials and technological characteristics.

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Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a bold, serif font. The text is centered on the image and is the only element present.

Public Health Service

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

DGIMed Ortho, Inc. % Mr. Scott Youngstrom 12400 Whitewater Drive, Suite 2010 Minnetonka, MN 55343

NOV - 5 2009

Re: K091309

Trade/Device Name: Revolution Femoral Intramedullary Nail System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: HSB Dated: September 25, 2009 Received: September 28, 2009

Dear Mr. Youngstrom:

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 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/cdrh/comp/ for the Center for Devices and Radiological Health's

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Page 2 - Mr. Scott Youngstrom

(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/cdrl/mdr/ 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/cdrh/industry/support/index.html.

Sincerely yours,

Mark A. Milkenso

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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DGIMed Ortho, Inc. Traditional 510(k) Premarket Notification: Revolution Femoral Intramedullary Nail

### INDICATIONS FOR USE STATEMENT ನ

# Indications for Use

510(k) Number (if known): not yet assigned

Device Name: Revolution Femoral Intramedullary Nail System

Indications for Use:

The Revolution Femoral Intramedullary Nail System is indicated for use in orthopaedic intramedullary nailing procedures: midline femoral fractures, femoral fractures in multiple trauma patients, fractures in the morbidly obese patient, fractures in osteoporotic bone or malunions and nonunions.

Prescription Use V (Part 21 CFR 801 Subpart D)

510(k) Number _

AND/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)

Oasta for mxn

1091309

(Division Sign-Division of Surgical, Orthopedic, and Restorative Devices

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CONFIDENTIAL

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