2MM PEDIATRIC FLEX NAIL

K022531 · Biomet, Inc. · HTY · Aug 26, 2002 · Orthopedic

Device Facts

• Record ID: K022531
• Device Name: 2MM PEDIATRIC FLEX NAIL
• Applicant: Biomet, Inc.
• Product Code: HTY · Orthopedic
• Decision Date: Aug 26, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

Flexible Pediatric Fixation Nails are to be used for treatment of long-bone fractures including non-comminuted and comminuted mid-shaft fractures, subtrochanteric fractures, distal third fractures, combination fractures of the shaft and neck, intertrochanteric fractures, combination intertrochanteric and subtrochanteric fractures.

Device Story

2mm Flexible Pediatric Nail; intramedullary rod for long-bone fracture fixation. Device used in pairs; bent to provide three-point fixation at insertion site, fracture site, and beyond fracture site. Operates as mechanical bone fastener. Used by surgeons in clinical settings. Provides structural stability to facilitate bone healing.

Clinical Evidence

No clinical data provided; substantial equivalence based on engineering justification and comparison to predicate device.

Technological Characteristics

Metallic intramedullary rod; 2mm diameter; flexible design for three-point fixation. Class II device (21 CFR 888.3040).

Indications for Use

Indicated for pediatric patients requiring treatment of long-bone fractures, including mid-shaft, subtrochanteric, distal third, and intertrochanteric fractures.

Regulatory Classification

Identification

A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

• Pediatric Fixation Rods (K000764)

Submission Summary (Full Text)

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AUG 26 2002

022531

## BOMET

## SUMMARY OF SAFETY AND EFFECTIVENESS

| Sponsor: | Biomet, Inc.<br>56 East Bell Drive<br>P.O. Box 587<br>Warsaw, IN 46581-0587 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Tracy J. Bickel<br>[phone] |
| Proprietary Name: | 2mm Flexible Pediatric Nail |
| Common Name: | Intramedullary Rod |
| Classification Name: | Smooth or threaded metallic bone fastener (21 CFR 888.3040) |
| Substantially Equivalent Devices: Pediatric Fixation Rods- K000764 | |
| Device Description: | The device is the same as flexible pins and ender nails that have been used to fix<br>fractures in long bones for years in an intramedullary fashion. When these types of<br>nails are used they will be used opposingly in pairs. The nail will be bent to provide<br>three-point fixation. The ideal fixation points will be at the insertion site, the fracture<br>site, and some point beyond the fracture site. |
| Indications for Use: | Flexible Pediatric Fixation Nails are to be used for treatment of long-bone fractures<br>including non-comminuted and comminuted mid-shaft fractures, subtrochanteric<br>fractures, distal third fractures, combination fractures of the shaft and neck,<br>intertrochanteric fractures, combination intertrochanteric and subtrochanteric<br>fractures. |
| Summary of Technologies: The device's technological characteristics (materials, design, sizing, and<br>indications) are similar or identical to the predicate device. | |
| Non-Clinical Testing: | An engineering justification was used to determine that the 2mm flexible pediatric<br>nail presented no new risks and were; therefore, substantially equivalent to the<br>predicate device. |
| Clinical Testing: | None provided as a basis for substantial equivalence. |

All trademarks are property of Biomet, Inc.

MAILING ADDRESS P.O. Box 587 Warsaw, IN 46581-0587

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SHIPPING ADDRESS 56 E. Bell Drive Warsaw, IN 46582

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OFFICE 574.267.6639

FAX [phone]

:

E-MAIL [e-mail]

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/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 three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 26 2002

Ms. Tracy J. Bickel Regulatory Specialist Biomet, Inc. P.O. Box 587 Warsaw, IN 46581-0587

Re: K022531

Trade/Device Name: 2mm Flexible Pediatric Nail Regulation Number: 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HTY Dated: July 30, 2002 Received: July 31, 2002

Dear Ms. Bickel:

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 -- Ms. Tracy J. Bickel

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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.

Sincerely yours,

Mark N. Millenson

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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510(k) Number (if known): Device Name: 2mm Flexible Pediatric I Indications for Use:

Flexible Pediatric Fixation Nails are to be used for treatment of long-bone fractures including r lextore roauted and comminuted mid-shaft fractures, subtrochanteric fractures, distal third from conmination fractures of the shaft and neck, intertrochanteric fractures, combination intertrochanteric and subtrochanteric fractures.

Mark N. Melleur
(Division Sign-Off)

Division of General, Restorative and Neurological Devices

510(k) Number (02253)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use (Optional Format 1-2-96)