SYNTHES (USA) RETROGRADE/ANTEGRADE FEMORAL NAIL SYSTEM

K033618 · Synthes (Usa) · HSB · Feb 5, 2004 · Orthopedic

Device Facts

• Record ID: K033618
• Device Name: SYNTHES (USA) RETROGRADE/ANTEGRADE FEMORAL NAIL SYSTEM
• Applicant: Synthes (Usa)
• Product Code: HSB · Orthopedic
• Decision Date: Feb 5, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3020
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Synthes Retrograde/Antegrade Femoral Nail System is intended to stabilize fractures of the distal femur and the femoral shaft, including: supracondylar fractures, including those with intra-articular extension; ipsilateral hip/shaft fractures; ipsilateral femur/tibia fractures; femoral fractures in multiple trauma patients; fractures proximal to total knee arthroplasty; fractures distal to a hip implant; fractures in the morbidly obese; fractures in osteoporotic bone, impending pathologic fractures; and malunions and nonunions.

Device Story

Intramedullary fixation system for stabilization of distal femur and femoral shaft fractures. Components include titanium alloy femoral nails, spiral blades, and end caps; used with locking bolts and screws to secure nail in bone, preventing rotation and axial compression. Inserted via retrograde or antegrade approach depending on nail length. Used by orthopedic surgeons in clinical/surgical settings to treat complex femoral fractures, including those in osteoporotic or morbidly obese patients. Provides mechanical stabilization to facilitate bone healing.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design and technological characteristics.

Technological Characteristics

Intramedullary fixation rod system. Material: Titanium alloy. Components: Femoral nails, spiral blades, end caps, locking bolts, screws. Mechanical fixation principle. Dimensions vary by length to accommodate retrograde or antegrade surgical approaches.

Indications for Use

Indicated for stabilization of distal femur and femoral shaft fractures in patients including those with supracondylar fractures (with/without intra-articular extension), ipsilateral hip/shaft or femur/tibia fractures, multiple trauma, fractures near existing implants (knee/hip), morbid obesity, osteoporotic bone, impending pathologic fractures, 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

• Synthes Distal Femoral Nail
• Synthes Cannulated Femoral Nail
• DePuy ACE ART Femoral Nail

Submission Summary (Full Text)

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FEB - 5 2004

ATTACHMENT III: REVISED 510(k) SUMMARY

| Revised 510(k) Summary: | |
|-------------------------|--|
| | |

| Sponsor: | Synthes (USA)<br>1690 Russell Road<br>Paoli, PA 19301<br>[phone] |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Bonnie Smith |
| Device Name: | Synthes (USA) Retrograde/Antegrade Femoral Nail System |
| Device Classification: | 21 CFR 888.3020 - "Intramedullary fixation rod"<br>21 CFR 888.3040 - "Smooth or threaded metallic bone<br>fixation fastener" |
| Predicate Device: | Synthes Distal Femoral Nail, Synthes Cannulated Femoral Nail, and<br>DePuy ACE ART Femoral Nail. |
| Description of Device: | Synthes Retrograde/Antegrade Femoral Nail System is composed of<br>femoral nails, spiral blades and end caps. Depending on the length of<br>the nail, the nail may be inserted from a retrograde approach or from<br>either a retrograde or antegrade approach. Spiral blades, end caps<br>and Synthes commercially available locking bolts and screws are<br>used to secure the nail in the bone, preventing rotation and axial<br>compression. |
| Indications: | Synthes Retrograde/Antegrade Femoral Nail System is intended to<br>stabilize fractures of the distal femur and the femoral shaft, including<br>supracondylar fractures, including those with intra-articular extension;<br>ipsilateral hip/shaft fractures; ipsilateral femur/tibia fractures; femoral<br>fractures in multiple trauma patients; fractures proximal to total knee<br>arthroplasty; fractures distal to a hip implant; fractures in the morbidly<br>obese; fractures in osteoporotic bone, impending pathologic fractures;<br>and malunions and nonunions. |
| Material: | Titanium alloy |
| Substantial Equivalence: | Documentation is provided which demonstrates that the Synthes<br>Retrograde/Antegrade Femoral Nail System is substantially<br>equivalent* to other legally marketed devices. |
| | * The term "substantially equivalent" as used in this 510(k) notification is<br>limited to the definition of substantial equivalence found in the Food, Drug,<br>and Cosmetic Act, as amended and as applied under 21 CFR 807, Subpart E,<br>under which a device can be marketed without pre-market approval or<br>reclassification. A determination of substantial equivalency under this<br>notification is not intended to have any bearing whatsoever on the resolution<br>of patent infringement suits or any other patent matter. No statements related<br>to, or in support of substantial equivalence herein shall be construed as an<br>admission against interest under the US Patent Laws or their application by the<br>courts. |

Ko3618

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Image /page/1/Picture/1 description: The image is a circular seal or logo. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the seal is a stylized symbol that resembles three wavy lines or stripes, possibly representing a flag or a symbol of movement and progress.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB - 5 2004

Ms. Bonnie J. Smith Senior Regulatory Affairs Associate Synthes (USA) 1690 Russell Road P.O. Box 1766 Paoli. Pennsylvania 19301

Re: K033618

Trade/Device Name: Synthes (USA) Retrograde/Antegrade Femoral Nail System Regulation Numbers: 21 CFR 888.3020 and 888.3040 Regulation Names: Intramedullary fixation rod and Smooth or threadcd metallic bone fixation fastener Regulatory Class: II Product Codes: IISB, HWC Dated: November 17, 2003 Received: November 18, 2003

Dear Ms. Smith:

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 he 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 sct 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 - Ms. Bonnie J. Smith

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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/dsma/dsmamain.html

Sincerely yours,

Mark A. Melleuson

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K033618

Device Name:

Indications for Use:

Synthes (USA) Retrograde/Antegrade Femoral Nail System

Synthes Retrograde/Antegrade Femoral Nail System is intended to stabilize fractures of the distal femur and the femoral shaft, including:

- · supracondylar fractures, including those with intraarticular extension
- · ipsilateral hip/shaft fractures
- ipsilateral femur/tibia fractures .
- femoral fractures in multiple trauma patients .
- fractures proximal to total knee arthroplasty .
- fractures distal to a hip implant .
- fractures in the morbidly obese �
- fractures in osteoporotic bone .
- impending pathologic fractures .
- · malunions and nonunions

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use ✗
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
fo Mal A Millers