ULTIMAX DISTAL RADIAL (VOLAR) LOCKING PLATE SYSTEM

K990481 · Biodynamic Technologies, Inc. · HRS · Mar 17, 1999 · Orthopedic

Device Facts

• Record ID: K990481
• Device Name: ULTIMAX DISTAL RADIAL (VOLAR) LOCKING PLATE SYSTEM
• Applicant: Biodynamic Technologies, Inc.
• Product Code: HRS · Orthopedic
• Decision Date: Mar 17, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ULTiMAX™ brand Distal Radial (Volar) Locking Plate System is indicated for single use to stabilize distal fractures of the radius.

Device Story

ULTiMAX™ Distal Radial (Volar) Locking Plate System is an orthopedic implant used by surgeons in clinical settings to stabilize distal radius fractures. The system consists of a locking plate and associated hardware designed to provide rigid fixation of bone fragments. The device is implanted during surgical procedures to facilitate bone healing. It functions as a mechanical support structure to maintain anatomical alignment of the radius during the fracture recovery process.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Orthopedic locking plate system for distal radius fixation. Metallic construction. Designed for single-use surgical implantation.

Indications for Use

Indicated for patients requiring stabilization of distal radius fractures. Single use only.

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.

Submission Summary (Full Text)

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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

K990481 Re: ULTIMAX™ Distal Radial (Volar) Trade Name: Locking Plate System Requlatory Class: II Product Code: HRS and HWC Dated: February 8, 1999 February 16, 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 reguirements 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 requlations 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 regulation 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 requlations.

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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 Also, please note the Office of Compliance at [phone]. 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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## K990481

Page 1 of 1

| 510(k) Number: | Unknown |
|----------------|------------------------------------------------------|
| Device Name: | ULTIMAX ™ Distal Radial (Volar) Locking Plate System |

Indications For Use:

The ULTiMAX™ brand Distal Radial (Volar) Locking Plate System is indicated for single use to stabilize distal fractures of the radius.

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K990481

Prescription Use X

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)