BTI CORTICAL BONE SCREWS

K972403 · Biodynamic Technologies, Inc. · HWC · Aug 29, 1997 · Orthopedic

Device Facts

• Record ID: K972403
• Device Name: BTI CORTICAL BONE SCREWS
• Applicant: Biodynamic Technologies, Inc.
• Product Code: HWC · Orthopedic
• Decision Date: Aug 29, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The BTI™ brand Cortical Bone Screws are indicated for single use for osteotomy fixation, interfragmentary fixation, and for stabilizing fractures in metaphyseal and diaphyseal bone in long bones. Uses include arthrodesis of joints; stabilizing fractures of the medial malleolus and distal tibia; patella fractures; metatarsal fractures and fractures of the calcaneus and other bones in the foot; fractures of bones in the hand; proximal, distal and intercondylar fractures of the humerus; use with the BTI Compression Hip Screw System, BTI Humeral Intramedullary Rod Systems, and the BTI Distal Femoral Intramedullary Rod System.

Device Story

BTI™ Cortical Bone Screws are orthopedic fixation devices used for stabilizing fractures and arthrodesis in long bones, hand, and foot. The screws provide mechanical fixation to bone fragments. They are intended for use by surgeons in clinical or operating room settings. The device is used in conjunction with other BTI orthopedic systems, such as the Compression Hip Screw System and various Intramedullary Rod Systems. The screws facilitate bone healing by maintaining alignment and stability of bone segments. The device is strictly contraindicated for pedicular screw fixation in the spine.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Cortical bone screws for orthopedic fixation. Mechanical device; no energy source or software. Materials and specifications not detailed in provided text.

Indications for Use

Indicated for single use in patients requiring osteotomy fixation, interfragmentary fixation, or stabilization of fractures in metaphyseal and diaphyseal long bones, including joints, foot, hand, and humerus. Contraindicated for pedicular screw fixation/attachment to the cervical, thoracic, or lumbar vertebral column.

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.

Submission Summary (Full Text)

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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three wavy lines extending from its body, representing the department's services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 29 1997

Mr. Danny Hodgeman Biodynamic Technologies, Inc. 1425 East Newport Center Drive Deerfield Beach, Florida 33442

Re: K972403 BTI™ Cortical Bone Screws Regulatory Class: II Product Code: HWC Dated: June 24, 1997 Received: June 26, 1997

Dear Mr. Hodgeman:

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 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. Note that labeling or otherwise promoting a device for pedicular screw fixation/attachment would cause the device to be adulterated under 501(f)(1) of the Act. This device, if intended for use in pedicular screw fixation/attachment, would be found not substantially equivalent and would be a class III device under Section 513(f) of the Act. Class III devices are required to have an approved premarket approval (PMA) application prior to marketing. Accordingly:

- The package insert must prominently state that the device 1. is intended for the specific use(s) described in the enclosure only; and

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Page 2 - Mr. Danny Hodgeman

- You may not label or in any way promote this device for 2. pedicular screw attachment to, or fixation of the cervical, thoracic or lumbar vertebral column. If this device is a screw with outer diameters of 3 mm - 10 mm and overall lengths of 10 mm - 75 mm inclusively, the package insert must include the following statement, ... This device is not approved for screw "WARNING: attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine." Any pedicular screw fixation/attachment to the cervical, thoracic or lumbar vertebral column of this device is considered investigational and may only be investigated as a significant risk device in accordance with the investigational device exemption (IDE) regulations under 21 CFR, Part 812. All users of the device for pedicular screw fixation/attachment must receive approval from their respective institutional review boards (IRBs) and the Food and Drug Administration (FDA) prior to conduct of the investigation.
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 Regulations, Title 21, Parts 800 to 895. ਸੇ 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 requlation (21 CFR Part 820) and that, through periodic (QS) inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obliqation 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 Requlations.

This letter will allow you to begin marketing your device as described in your 5.0(k) premarket notification immediately. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and 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

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Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact che promotion and [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general promation 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,

~Celia M. Witten, Ph.D., M.D. 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: K972403

Device Name: BTI™ Cortical Bone Screws - --------------------------------------------------------------------------------------------------------------------------------------------------"

## Indications For Use:

The BTI™ brand Cortical Bone Screws are indicated for single use for osteotomy fixation, interfragmentary fixation, and for stabilizing fractures in metaphyseal and diaphyseal bone in long bones. Uses include arthrodesis of joints; stabilizing fractures of the medial malleolus and distal tibia; patella fractures; metatarsal fractures and fractures of the calcaneus and other bones in the foot; fractures of bones in the hand; proximal, distal and intercondylar fractures of the humerus; use with the BTI Compression Hip Screw System, BTI Humeral Intramedullary Rod Systems, and the BTI Distal Femoral Intramedullary Rod System.

| Concurrence of CDRH, Office of Device Evaluation (ODE) | | | |
|--------------------------------------------------------|---------|----|----------------------|
| Prescription Use | X | OR | Over-The-Counter Use |
| (Optional Format 1-2-96) | | | |
| (Division Sign-Off) | | | |
| Division of General Restorative Devices | | | |
| 510(k) Number | K972403 | | |