ULTIMAX CORTICAL BONE SCREWS

K990513 · Biodynamic Technologies, Inc. · HWC · Mar 17, 1999 · Orthopedic

Device Facts

• Record ID: K990513
• Device Name: ULTIMAX CORTICAL BONE SCREWS
• Applicant: Biodynamic Technologies, Inc.
• Product Code: HWC · Orthopedic
• Decision Date: Mar 17, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ULTiMAX™ 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 ULTiMAX™ Humeral Intramedullary Rod System.

Device Story

ULTiMAX™ Cortical Bone Screws are orthopedic fixation devices used for stabilizing fractures and performing arthrodesis. The screws are implanted by surgeons in an operating room setting to provide mechanical fixation of bone fragments. They are designed for use in various anatomical locations, including long bones, foot, hand, and humerus, and are compatible with the BTI ULTiMAX™ Humeral Intramedullary Rod System. The device provides structural stability to bone segments to facilitate healing. It is a single-use, sterile implant.

Clinical Evidence

Bench testing only.

Technological Characteristics

Cortical bone screws; metallic implant; single-use; sterile; designed for orthopedic fixation.

Indications for Use

Indicated for patients requiring osteotomy fixation, interfragmentary fixation, or stabilization of metaphyseal and diaphyseal long bone fractures, including joints, foot, hand, and humerus 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.

Reference Devices

• BTI ULTiMAX™ Humeral Intramedullary Rod System

Submission Summary (Full Text)

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Image /page/0/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 lines forming its body and head. The eagle is facing to the right. 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

MAR 1 7 1999

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

Re: K990513 ULTIMAX™ Cortical Bone Screws Trade Name: Regulatory Class: II Product Code: HWC February 15, 1999 Dated: February 18, 1999 Received:

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 The general controls provisions of the Act 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 (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. ಕ್ಕೆ 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, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. 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. Danny Hodgeman

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,

Celia M. Witten, Ph.D.

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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## K990513

Page 1 of 1

510(k) Number: Unknown

Device Name: ULTiMAX™ Cortical Bone Screws

## Indications For Use:

Prescription Use _____________________________________________________________________________________________________________________________________________________________

The ULTiMAX™ 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 ULTiMAX™ Humeral Intramedullary Rod System.

Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | |
|-----------------------------------------|---------|
| Division of General Restorative Devices | |
| 510(k) Number | K990513 |

OR

(Optional Format 1-2-96)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________