BONE BAND

K983685 · Chapel and Assoc. · LYT · Dec 4, 1998 · Orthopedic

Device Facts

• Record ID: K983685
• Device Name: BONE BAND
• Applicant: Chapel and Assoc.
• Product Code: LYT · Orthopedic
• Decision Date: Dec 4, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2

Indications for Use

This bone band is indicated for use in orthopedic surgery as an aid for reducing fractures and for the positioning of bone fixation plates.

Device Story

Bone Band is a single-patient-use, non-implantable orthopedic surgical aid. Device consists of a 17.0" x 0.20" x 0.05" biocompatible nylon strip with slotted ends. Used by surgeons during orthopedic procedures to assist in fracture reduction and positioning of bone fixation plates. Device is provided sterile. It serves as a mechanical aid for temporary positioning; does not remain in the patient.

Clinical Evidence

Bench testing only.

Technological Characteristics

Material: Biocompatible nylon. Dimensions: 17.0" length, 0.20" width, 0.05" thickness. Form factor: Strip with 0.1" x 0.5" slots at each end. Surface: Smooth with radiused edges. Sterilization: Sterile. Usage: Single-patient use. Non-implantable.

Indications for Use

Indicated for use in orthopedic surgery as an aid for reducing fractures and for the positioning of bone fixation plates in patients requiring such surgical intervention.

Regulatory Classification

Identification

Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

• Particate device (Zimmer, Inc.)

Submission Summary (Full Text)

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## Chapel and Associates

DEC 4 1998 1019 Ridgecrest Circle Denton, Texas 76205 [phone]

## 510(K) Summary

K983685

Date: 14 October 1998

Trade Name:Bone Band

Common Name: Bone Band

Classification Name: Unknown

Device Description: The bone band device consists of a 0.20" wide by 0.05" thick by 17.0" long strip of biocompatable nylon with a 0.1" wide x 0.5" long slot at each end. The surface of the band is smooth with radiused edges.

Intended Use: This bone band is indicated for use in orthopedic surgery as an aid for the positioning of bone fixation plates.

Substantial Equivalence: This bone band submitted device is substantially equivalent to the Particate device currently being sold in the United States by Zimmer, Inc. P.O. Box 708, Warsaw, IN 46581. To the best of our knowledge, this predicate devices is being "legally" marketed

Predicate Device

Stainless steel

7.56 x 0.20 x 0.025

Reuseable

Non-sterile

Non-implantable

mparison to Predicate Device:

Attribute Material of construction Length x Width x Thickness (inches Reuseability Sterility Implantation

Submitter's Name Submitter's Address: Submitter's Phone #: Submitter's Contact Person: Chapel and Associates 1019 Ridgecrest Circle, Denton, TX 76205 [phone] James F. Chapel

Submitted Device Biocompatable Nylon 17.0 x 0.20 x 0.05 Single Patient Use Sterile Non-implantable

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure embracing a globe, symbolizing the department's mission to protect the health of all Americans. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the emblem.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC = 4 1998

Mr. James F. Chapel President Chapel and Associates 1019 Ridgecrest Circle Denton, Texas 76205

Re : K983685 Bone Band Regulatory Class: II Product Code: LYT Dated: October 14, 1998 Received: October 20, 1998

Dear Mr. Chapel:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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## Page 2 - Mr. James F. Chapel

This letter will allow you to begin marketing your device as described in your 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 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Colin M. Whitten, Ph. D.

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

Enclosure

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510(k) Number:

Device: Bone band

Indications For Use: This bone band is indicated for use in orthopedic surgery as an aid for reducing fractures and for the positioning of bone fixation plates.

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

| | Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|------------------------------------------|--------------------------------------------------------|----------------------|
| | (Division Sign-Off) | |
| | Division of General Restorative Devices | |
| 510(k) Number | K983685 | |
| Prescription Use<br>(Per 21 CFR 801.109) | OR | Over-the-Counter Use |

(Optional Format 1-2-96)