ULTIMAX ANKLE FUSION ROD SYSTEM

K991790 · Encore Orthopedics, Inc. · HSB · Aug 6, 1999 · Orthopedic

Device Facts

• Record ID: K991790
• Device Name: ULTIMAX ANKLE FUSION ROD SYSTEM
• Applicant: Encore Orthopedics, Inc.
• Product Code: HSB · Orthopedic
• Decision Date: Aug 6, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3020
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The UltiMax Ankle Fusion Rod System is indicated for single use for arthrodesis of the ankle joint.

Device Story

UltiMax Ankle Fusion Rod System is a metallic bone fixation device for ankle arthrodesis. Device consists of a titanium (ASTM F136) intramedullary rod with sharp flutes for stability; bi-diameter geometry; cannulated for 2mm guide wire. System includes transfixing cortical screws for proximal tibial and distal calcaneal fixation. Features a compression slot allowing up to 25mm of static or dynamic compression at the ankle joint via compression screws. Used by surgeons in clinical settings to stabilize the ankle joint during fusion procedures. Provides mechanical fixation to facilitate bone healing.

Clinical Evidence

Bench testing only.

Technological Characteristics

Titanium (6Al-4V ELI) per ASTM F136. Intramedullary rod with sharp flutes, bi-diameter design, and cannulation. Includes transfixing cortical screws and compression screws. Lengths 150-325mm; diameters 11mm and 13mm. Mechanical fixation device.

Indications for Use

Indicated for patients requiring arthrodesis of the ankle joint.

Regulatory Classification

Identification

An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.

Submission Summary (Full Text)

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## K991790

Encore Orthopedics®, Inc. 9800 Metric Blvd Austin, TX 78758 512-832-9500

## Trade Name: UltiMax Ankle Fusion Rod System

Common Name: Ankle Fusion Rod

Classification Name: Single/multiple component metallic bone fixation appliances and accessories 21 CFR 888.3030

Device Description: All components of the UltiMax Ankle Fusion Rod System are manufactured from titanium (6A1-4V ELI) per ASTM F136.

The rod geometry features sharp flutes to obtain initial stability. The rod is bi-diameter to maximize strength in the distal region, tapering down 2mm to accommodate the tibial intramedullary canal. The rod is locked with one or two 5mm transfixing screws in the tibia proximally and are screwed distally in the calcaneous. Rods range in lengths from 150mm == 325mm (25mm increments) and diameters of 11mm and 13mm. Transfixing cortical screws are available in lengths ranging from 60-100mm in 2mm increments.

The rod also features a unique "compression slot" allowing up to 25mm of static or dynamic compression at the ankle joint. This is achieved with compression screws through the distal cannulation being driven against a distal transfixing screw. The compression screws are available in 12mm, 22mm, and 32mm lengths. The rod is fully cannulated for use with a small 2mm guide wire. The small cannulation maintains optimal strength while allowing traditional techniques for rodding.

Intended Use: The UltiMax Ankle Fusion Rod System is indicated for single use for arthrodesis of the ankle joint.

Comparable Features to Predicate Device(s): Based on the intended uses, design, testing, and manufacturing, the UltiMax Ankle Fusion Rod System is equivalent to the referenced legally marketed comparison devices.

Test Results: Testing was performed on the UltiMax Ankle Fusion System. Test results proved the device to be of sound design.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the logo is an abstract symbol that resembles an eagle or bird in flight.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG -6 1999

Ms. Debbie De Los Santos Regulatory/Clinical Specialist Encore Orthopedics 9800 Metric Boulevard Austin, Texas 78758

Re: K991790

Trade Name: Ultimax Ankle Fusion Rod System Regulatory Class: II Product Code: HSB Dated: May 24, 1999 Received: May 26, 1999

Dear Ms. De Los Santos:

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 control provisions of the Act. The general control 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 (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. 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 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.

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.

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Page 2 – Ms. Debbie De Los Santos

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 at [phone], or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

ia 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 (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use:

## UltiMax Ankle Fusion Rod Indications For Use

The UltiMax Ankle Fusion Rod System is indicated for single use for arthrodesis of the ankle joint.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)_

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(Division Sign-Off) Division of General Restorative Devices 12991790 510(k) Number