MODIFICATION TO ISKD (INTRAMEDULLARY SKELETAL KINETIC DISTRACTOR)

K031219 · Orthofix, Inc. · HSB · May 28, 2003 · Orthopedic

Device Facts

• Record ID: K031219
• Device Name: MODIFICATION TO ISKD (INTRAMEDULLARY SKELETAL KINETIC DISTRACTOR)
• Applicant: Orthofix, Inc.
• Product Code: HSB · Orthopedic
• Decision Date: May 28, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3020
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ISKD is indicated for limb lengthening of the tibia and femur.

Device Story

ISKD is an intramedullary limb lengthening system for tibia and femur. Device consists of a telescoping internal implant, titanium locking screws, and an external handheld monitor. Principle of operation: patient performs rotational limb oscillations during ambulation; one-way clutch and threaded rod mechanism converts motion into gradual osteogenic distraction. Internal magnet rotates with distraction; external monitor (electronic compass-like) tracks magnet pole changes to measure progress. Used in clinical/home settings; operated by patient (ambulation) and monitored by physician/patient. Output provides daily lengthening progress data to inform clinical decisions and manage distraction rates. Benefits include controlled, gradual limb lengthening.

Clinical Evidence

Bench testing only. Mechanical and functional testing conducted per ASTM 1264, including 4-point bend, fatigue, and torsion testing. Results demonstrated the 10.7mm lengthener performs as well as the 12.5mm predicate device.

Technological Characteristics

Intramedullary nail; telescoping design; one-way clutch mechanism. Material: Ti6Al4V ELI (ASTM F136). Dimensions: 10.7mm diameter. Fixation: 4.0mm and 4.8mm locking screws. Monitoring: External handheld magnetic tracking monitor. Sterilization: Ethylene oxide (implant); steam (instruments).

Indications for Use

Indicated for limb lengthening of the tibia and femur in patients requiring intramedullary fixation.

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.

Predicate Devices

• Orthofix Inc. 12.5mm internal limb lengthener (K010322)

Submission Summary (Full Text)

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# MAY 2 8 2003

K031219
Page 1 of 3

# SUMMARY OF SAFETY AND EFFECTIVENESS Orthofix Inc. ISKD Internal Limb Lengthening System

## 1. GENERAL INFORMATION

| Classification Name: | Intramedullary fixation rod |
|--------------------------------|----------------------------------------------------------------------------------|
| Common Name: | Internal Limb Lengthener |
| Device Trade Name: | "ISKD":<br>(Intramedullary Skeletal Kinetic<br>Distractor) |
| Classification Code(s): | 21 CFR Parts 888.3020 |
| Submitter's Name & Address: | Orthofix Inc.<br>1720 Bray Central Drive<br>McKinney, TX 75069<br>[phone] |
| Establishment Registration No: | 2183449 |
| Contact Person: | Mary Biggers, RAC<br>469-742-2561 |
| Summary Preparation Date: | April 7, 2003 |

# 11. Predicate Device

The Orthofix Inc. ISKD System 10.7mm internal limb lengthener is substantially equivalent in design, function and intended use to the Orthofix Inc. 12.5mm internal limb lengthener. The Orthofix ISKD 12.5mm internal limb lengthener, manufactured by Orthofix Inc. of McKinney, Texas, was originally cleared by FDA under K010322 on May 2, 2001.

### 111. DEVICE DESCRIPTION

The ISKD System is an intramedullary limb lengthening system that provides gradual, controlled osteogenic distraction of the tibia and femur. The ISKD System consists of the telescoping internal limb lengthening device, titanium locking screws, instrumentation and an external handheld Monitor. As the patient performs rotational oscillations of the affected limb during normal ambulation, the ISKD distracts as the distal section of the implant gradually telescopes out of the proximal section. The distraction is controlled by a one-way clutch mechanism and a threaded rod. A small magnet sealed within the ISKD implant rotates simultaneously as the implant distracts. The hand-held external Monitor is similar to an

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electronic compass and communicates with the magnet by detecting a tracking changes in the magnet poles. The external Monitor enables both patients and physicians to monitor the daily limb lengthening progress. The addition of the 10.7mm lengthener will provide surgeons with a device option for patients requiring a smaller diameter implant.

### IV. INDICATIONS FOR USE

The ISKD System intended for limb lengthening of the femur and tibia.

#### V. BIOMECHANICAL TESTING

In order to demonstrate that the 10.7 ISKD Limb Lengthener has the mechanical properties necessary to perform its intended use, and that the ISKD Internal Limb Lengthener performs as well as or better than the predicate device, Orthofix has conducted mechanical and functional testing of the 10.7mm lengthener in accordance with ASTM 1264. Standard Specification and Test Methods for Intramedullary Fixation Devices. These tests consist of 4-point bend, fatigue and torsion testing. The testing was successfully completed demonstrating the 10.7mm lengthener performs as well as the 12.5mm ISKD lengthener.

#### VI. BIOCOMPATIBILITY

The ISKD Internal Limb Lengthening device and locking screws are made from titanium alloy, Ti6A14V ELI conforming to ASTM F136.

#### X. Sterilization

The ISKD Internal Limb Lengthener is sterilized by exposure to ethylene oxide gas. The Instrumentation and devices provided non-sterile must be sterilized prior to use using the parameters identified below:

| ISKD Non-Sterile Devices/Instruments | |
|--------------------------------------|--------------------------------------------------------------------------|
| Method | Steam Sterilization |
| Cycle | Pre-Vacuum |
| Temperature | 132° - 135° C [270° - 275°F] |
| Exposure Time | Minimum of 10 minutes |
| Sterility Assurance Level (SAL) | 10-6 |
| Sterility Validation Method | ANSI/AAMI ST46-1993- Prevacuum<br>Steal Sterilization of Medical Devices |

# X. SUBSTANTIAL EQUIVALENCE

The 10.7mm ISKD Tibial Internal Limb Lengthener is claimed to be substantially equivalent in design and function to the 12.5mm ISKD Tibial Internal Limb Lengthener. The 12.5mm ISKD received 510(k) clearance under K010322 on May 2, 2001.

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031219
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| Features | ISKD 10.7mm | ISKD 12.5MM |
|------------------------------|-------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|
| Intended Use | "Limb lengthening of the tibia<br>and femur" | "Limb lengthening of the tibia and<br>femur" |
| MATERIAL | Ti6A14V ELI | Ti6A14V ELI |
| DESIGN FEATURES | Intramedullary nail<br>Telescoping sections<br>One way clutch design | Intramedullary nail<br>Telescoping sections<br>One way clutch design |
| METHOD OF<br>FIXATION | 4.0 mm & 4.8mm diameter<br>locking screws | 4.8mm diameter locking screws |
| NUMBER OF<br>FIXATION POINTS | 2 proximal/2 distal | 2 proximal/2 distal |
| DESIGN OF ENDS | Blunt | Blunt |
| CROSS<br>SECTIONAL SHAPE | Circular | Circular |
| RATE OF<br>LENGTHENING | Physician to determine rate.<br>Dependent upon patient<br>activity level; .75-1.25 mm/day | Physician to determine rate.<br>Dependent upon patient activity level;<br>.75-1.25 mm/day |
| CONTROL OF<br>LENGTHENING | Patient's activity level, i.e.,<br>rotational oscillations of the<br>limb | Patient's activity level, i.e., rotational<br>oscillations of the limb |
| MONITORING OF<br>DISTRACTION | External hand held monitor;<br>X-rays for confirmation | External hand held monitor;<br>X-rays for confirmation |
| SAFETY FEATURES | Automatic stop when<br>predetermined length is<br>achieved. And one-way clutch<br>design | Automatic stop when predetermined<br>length is achieved. And one-way<br>clutch design |
| SIZE RANGES<br>(LENGTHS) | 10.5 (215-350mm) | 12.5 (255-435mm) |
| INVASIVE<br>COMPONENTS | Intramedullary limb lengthener,<br>Locking screws | Intramedullary limb lengthener<br>Locking screws |

#### XI. CONCLUSION

Based upon the results of biomechanical testing the ISKD 10.7mm internal limb lengthener has the mechanical properties to perform its intended use of limb lengthening of the tibia and is considered to be substantially equivalent to the predicate device in design, material and intended use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of an eagle or bird with three lines forming its body and head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird image.

Public Health Service

***_*****_ and**, and I will be happy to help.

MAY 2 8 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Mary Biggers, RAC Manager, Regulatory Affairs Orthofix, Inc. 1720 Bray Central Drive McKinney, Texas 75069

Re: K031219

Trade/Device Name: ISKD (Intramedullary Skeletal Kinetic Distractor) System Regulation Numbers: 21 CFR 888.3020 Regulation Names: Intramedullary fixation rod Regulatory Class: II Product Codes: HSB Dated: April 11, 2003 Received: April 17, 2003

Dear Ms. Biggers:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Kim P. Kelly, MS

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

. Mark N. Malkinson

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

Enclosure

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# Indication for Use Statement

Page 1 of 1

K0312i9

510(k) Number (if known):

Device Name:

"ISKD" Intramedullary Skeletal Kinetic Distractor

Indications for Use:

The ISKD is indicated for limb lengthening of the tibia and femur.

(Please Do NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use: (Per 21 CFR 801.109) Or

Over-The-Counter (Optional Format 1-2-96)

for Mark A. Millerman

Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K0310