RADIOLUCENT COLLES COMPRESSION/DISTRACTION BAR

K021182 · Biomet, Inc. · JDW · May 13, 2002 · Orthopedic

Device Facts

• Record ID: K021182
• Device Name: RADIOLUCENT COLLES COMPRESSION/DISTRACTION BAR
• Applicant: Biomet, Inc.
• Product Code: JDW · Orthopedic
• Decision Date: May 13, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Stabilization of open and/or unstable fractures and where soft tissue injury may preclude the use of other fracture treatments such as IM Rodding, casting, and other means of internal fixation.

Device Story

External fixator for fracture stabilization; consists of carbon fiber rod with aluminum cap, partially threaded aluminum bar, and stainless steel circular nuts. Device allows compression or distraction modes via manual adjustment of nuts on pin. Used by clinicians in surgical or clinical settings to stabilize fractures when internal fixation or casting is contraindicated due to soft tissue injury. Provides mechanical support to bone segments to facilitate healing.

Clinical Evidence

No clinical data provided. Substantial equivalence based on non-clinical bench testing including cantilever, torsional, and Sawbone lab testing.

Technological Characteristics

Materials: carbon fiber rod, aluminum cap/bar, stainless steel nuts. Design: external fixator with compression/distraction mechanism. Mechanical operation: manual adjustment of circular nuts on threaded rod. Non-sterile/sterilization method not specified. No software or electronic components.

Indications for Use

Indicated for patients with open and/or unstable fractures where soft tissue injury precludes alternative treatments like IM rodding, casting, or internal fixation.

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

• Biomet® Radiolucent Colles Fracture Kit (K001760)

Submission Summary (Full Text)

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MAY 13 2002

CORPORAT ARTER

## 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: | Radiolucent Colles Compression/Distraction Bar |
| Common Name: | External Fixator |
| Classification Name: | Pin, Fixation, Threaded (888.3040) |
| Substantially Equivalent Devices: Biomet® Radiolucent Colles Fracture Kit (K001760) | |
| Device Description: | A carbon fiber rod has an aluminum cap threaded onto one end. That cap slides<br>axially in another bar that is partially externally threaded. There is a slot that runs the<br>length of the external thread that accepts a pin that is part of the aluminum cap. There<br>are two circular nuts that tighten on the pin which allow the device to be used in<br>either compression or distraction mode. The partially threaded rod is made of<br>aluminum and the circular nuts of made of stainless steel. |

Intended Use: Stabilization of open and/or unstable fractures and where soft tissue injury may preclude the use of other fracture treatments such as IM Rodding, casting, and other means of internal fixation.

Summary of Technologies: The device's technological characteristics (materials, design, sizing, and indications) are similar to or identical to the predicate device.

Non-Clinical Testing: The following tests were used to determine substantial equivalence: Cantilever Testing, Torsional Testing, and Sawbone Lab Testing.

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 000046 56 E. Bell Drive Warsaw, IN 46582

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OFFICE 219.267.6639

FAX [phone]

E-MAIL [e-mail]

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## MAY 1 3 2002

Ms. Tracy J. Bickel Regulatory Specialist Biomet. Inc. 56 East Bell Drive P.O. Box 587 Warsaw, IN 46581-0587

Re: K021182

Trade/Device Name: Radiolucent Colles Compression/Distraction Bar Regulation Number: 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: JDW Dated: April 11, 2002 Received: April 15, 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 Ms. Tracy J. Bickel 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 A. Milikman

Celia 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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Page of

510(k) Number (if known): Device Name: Radiolucent Colles Compression/Distraction Bar Indications for Use:

Stabilization of open and/or unstable fractures and where soft tissue injury may preclude the use of other fracture treatments such as IM Rodding, casting, and other means of internal fixation.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Mark N. Milk

(Division Sign-Off Division of General, Restorative and Neurological Devices

510(k) Number K021182

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

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