ZIMMER NATURAL NAIL SYSTEM TIBIAL NAIL

K082770 · Zimmer, Inc. · HSB · Dec 11, 2008 · Orthopedic

Device Facts

• Record ID: K082770
• Device Name: ZIMMER NATURAL NAIL SYSTEM TIBIAL NAIL
• Applicant: Zimmer, Inc.
• Product Code: HSB · Orthopedic
• Decision Date: Dec 11, 2008
• 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 the Tibial nails include the following in the tibia: - 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

Device Story

Zimmer Natural Nail System Tibial Nail; temporary intramedullary fixation rod for tibial fracture stabilization. Device consists of metallic nail available in various lengths/diameters; secured via proximal and distal screws; includes optional nail caps to prevent tissue ingrowth. Material: TI-6AL-4V alloy. Used in clinical/surgical settings by orthopedic surgeons. Provides mechanical stabilization of bone fractures to facilitate healing.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Intramedullary fixation rod; material: TI-6AL-4V alloy; mechanical fixation via proximal/distal screws; includes nail caps; various lengths/diameters.

Indications for Use

Indicated for patients requiring temporary fracture fixation and stabilization of the tibia, including compound, simple, proximal, metaphyseal, distal, segmental, comminuted, pathological, and periprosthetic fractures; fractures with bone loss; osteopenic/osteoporotic bone fractures; pseudoarthrosis; non-union; mal-union; delayed union; and 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

• Intramedullary Nail System (K965098)
• Sirus® Intramedullary Nail (K043270)
• DePuy Ace Versa Nail Tibial Nail (K032097)

Submission Summary (Full Text)

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#### 6002770 lps 1/2)

#### Summary of Safety and Effectiveness

# DEC 11 2008

Sponsor:

Contact Person:

Date:

Trade Name:

Common Name:

Classification Name and Reference:

Predicate Devices:

Device Description:

Zimmer, Inc. P.O. Box 708 Warsaw, IN 46581-0708

Daniel J. Williman Specialist, Warsaw Regulatory Affairs Telephone: [phone] Fax: [phone]

September 18, 2008

Zimmer® Natural Nail™ System Tibial Nail

Intramedullary Fixation Rod

Intramedullary fixation rod, product code HSB 21 CFR § 888.3020

Intramedullary Nail System, manufactured by Zimmer, Inc. (K965098, cleared February 28, 1997)

Sirus® Intramedullary Nail, manufactured by Zimmer, GmbH (K043270, clcared January 31, 2005)

DePuy Ace Versa Nail Tibial Nail, manufactured by DePuy Orthopaedics (K032097, cleared August 8, 2003)

The Zimmer Natural Nail System Tibial Nail is a temporary fixation intramedullary nail designed for fracture fixation and stabilization of the tibia. The intramedullary nails are available in a variety of lengths and diameters to meet assorted anatomical needs. Each of the nails is secured by a series of screws that pass through holes manufactured into the proximal and distal sections of each nail. Nail caps are available to prevent tissue ingrowth into nail threads and extend the length of the nail. All components are made of TI-6AL-4V alloy material.

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# K082770 (pg 212)

#### Intended Use: -

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

Indications for the Tibial nails include the following in the tibia:

- · 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

The Zimmer Natural Nail system is similar or identical in intended use, materials, sterility, and performance characteristics to the predicate devices.

Non-Clinical Performance and Conclusions:

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

Clinical Performance and Conclusions:

Clinical data and conclusions were not needed for this device.

#### Comparison to Predicate Device:

Performance Data (Nonclinical and/or Clinical):

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

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 stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular fashion around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# DEC 1 1 2008

Zimmer, Inc. % Mr. Daniel J. Williman Specialist, Warsaw Regulatory Affairs P.O. Box 708 Warsaw, IN 45681

Re: K082770

Trade/Device Name: Zimmer® Natural Nail™ System Tibial Nail Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary Fixation Rod Regulatory Class: II Product Code: HSB Dated: September 18, 2008 Received: September 22, 2008

#### 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 such 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); 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

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N Millerson

Mark N. Melkerson 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):

#### Device Name:

Zimmer® Natural Nai™ System Tibial Nail

#### Indications for Use:

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

Indications for the Tibial nails include the following in the tibia:

- . 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 .

| 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)

(Division Sign-Off)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of General, Restorative, and Neurological Devices

| 510(k) Number | k082770 |
|---------------|---------|
|---------------|---------|

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