ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS

K091566 · Zimmer GmbH · HSB · Oct 28, 2009 · Orthopedic

Device Facts

• Record ID: K091566
• Device Name: ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS
• Applicant: Zimmer GmbH
• Product Code: HSB · Orthopedic
• Decision Date: Oct 28, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3020
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Zimmer Natural Nail System is intended for temporary fracture fixation and stabilization of the bone. Indications for use of the Cephalomedullary nails include: · Compound and simple shaft fractures · Proximal, metaphyseal and distal shaft fractures · Segmental fractures · Comminuted fractures · Fractures involving osteopenic and osteoporotic bone · Pathological fractures · Fractures with bone loss · Pseudoarthrosis, non-union, mal-union and delayed union · Periprosthetic fractures · Surgically created defects such as osteotomies · Intertrochanteric and subtrochanteric fractures

Device Story

Zimmer Natural Nail System Cephalomedullary Nails are temporary intramedullary fixation devices for femoral fracture stabilization. System consists of metallic nails in various lengths/diameters, secured by proximal and distal screws; optional nail caps prevent tissue ingrowth. Used in surgical settings by orthopedic surgeons for fracture management. Device provides mechanical stability to bone segments, facilitating healing. Benefits include stabilization of complex fractures, including those in osteoporotic bone.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Intramedullary fixation rod; metallic construction; various lengths and diameters; proximal and distal screw fixation; includes nail caps; sterile.

Indications for Use

Indicated for patients requiring temporary fracture fixation and stabilization of the femur, including compound, simple, segmental, comminuted, pathological, periprosthetic, intertrochanteric, and subtrochanteric fractures; fractures involving osteopenic/osteoporotic bone; fractures with bone loss; pseudoarthrosis; non-union; mal-union; delayed union; and surgically created defects (osteotomies).

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

• Zimmer Natural Nail System Piriformis Fossa & Greater Trochanter Antegrade Femoral Nails (K083497)
• I.T.S.T. Intertrochanteric Subtrochanteric Intramedullary Femoral Nail (K032367)
• Intramedullary Nail System (K965098)

Submission Summary (Full Text)

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K 091566

# OCT 2 8 2009

# zımmer

# Summary of Safety and Effectiveness

| Sponsor: | Zimmer, GmbH<br>SulzerAllee 8<br>Winterthur, Switzerland CH-8404 |
|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Daniel J. Williman<br>Specialist, Regulatory Affairs<br>Telephone: [phone]<br>Fax: [phone] |
| Date: | May 27, 2009 |
| Trade Name: | Zimmer ^® Natural Nail ^™ System Cephalomedullary Nails |
| Common Name: | Intramedullary Fixation Rod |
| Classification Name and Reference: | Intramedullary fixation rod, product code HSB<br>21 CFR § 888.3020 |
| Predicate Devices: | Zimmer Natural Nail System Piriformis Fossa & Greater Trochanter Antegrade Femoral Nails, manufactured by Zimmer, Inc. (K083497, cleared February 19, 2009)<br>I.T.S.T. ^™ Intertrochanteric Subtrochanteric Intramedullary Femoral Nail, manufactured by Zimmer, Inc. (K032367, cleared August 12, 2003)<br>Intramedullary Nail System, manufactured by Zimmer, Inc. (K965098, cleared February 28, 1997) |
| Device Description: | The Zimmer Natural Nail System Cephalomedullary Nails are a family of temporary fixation intramedullary nails designed for fracture fixation and stabilization of the femur. The nails are available in a variety of lengths and diameters to meet assorted anatomical needs. Each of the intramedullary nails is secured by a series of screws that pass through holes manufactured into the proximal and distal sections of each nail. Nail caps |

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are available to prevent tissue ingrowth into nail threads and increase the length of the nail if desired.

The Zimmer Natural Nail System is intended for Intended Use: bone. include: · Compound and simple shaft fractures · Segmental fractures · Comminuted fractures bone · Pathological fractures · Fractures with bone loss · Pseudoarthrosis, non-union, mal-union and delayed union · Periprosthetic fractures The Zimmer Natural Nail System Comparison to Predicate Device:

Performance Data (Nonclinical and/or Clinical):

# temporary fracture fixation and stabilization of the

Indications for use of the Cephalomedullary nails

- · Proximal, metaphyseal and distal shaft fractures
- · Fractures involving osteopenic and osteoporotic
- · Surgically created defects such as osteotomies
- · Intertrochanteric and subtrochanteric fractures

Cephalomedullary Nails are similar or identical in intended use, materials, sterility, and performance characteristics to the predicate device(s).

Non-Clinical Performance and Conclusions:

The results of non-clinical (lab) performance testing demonstrate that the devices are safe and effective and substantially equivalent to the predicate devices.

Clinical Performance and Conclusions:

Clinical data and conclusions were not needed for this device.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird with outstretched wings.

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

Zimmer, GmbH % Mr. Daniel J. Williman Specialist, Regulatory Affairs P.O. Box 708 Warsaw, Indiana 46581-0708

OCT 2 8 2009

Re: K091566

Trade/Device Name: Zimmer Natural Nail™ System Cephalomedullary Nails Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: HSB Dated: October 7, 2009 Received: October 8, 2009

Dear Mr. Williman:

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.

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# Page 2 - Mr. Daniel J. Williman

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.

Sincerely yours,

Mark M. Milburn

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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# Indications for Use

# 510(k) Number (if known):

## Device Name:

Zimmer® Natural Nail™ System Cephalomedullary Nails

## Indications for Use:

The Zimmer Natural Nail System is intended for temporary fracture fixation and stabilization of the bone.

Indications for use of the Cephalomedullary nails include:

- · Compound and simple shaft fractures
- · Proximal, metaphyseal and distal shaft fractures
- Segmental fractures
- Comminuted fractures
- · Fractures involving osteopenic and osteoporotic bone
- · Pathological fractures
- · Fractures with bone loss
- · Pseudoarthrosis, non-union, mal-union and delayed union
- · Periprosthetic fractures
- · Surgically created defects such as osteotomies
- · Intertrochanteric and subtrochanteric fractures

Onuta for mxm
(Division Sign)m

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K091526

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

Over-The-Counter Use (21 CFR 807 Subpart C)

(Please do not write below this line - Continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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