(41 days)
Not Found
No
The device description details a mechanical lengthening mechanism controlled by patient ambulation and monitored by a magnetic sensor and external monitor. There is no mention of AI or ML in the device's operation or monitoring.
Yes
The device is described as an "intramedullary limb lengthening system" that provides "gradual, controlled osteogenic distraction of the tibia and femur" for the purpose of "limb lengthening." This directly indicates a therapeutic function of altering the body's structure to achieve a desired medical outcome.
No
The device description indicates that the system is used for "gradual, controlled osteogenic distraction" to lengthen limbs, and the Monitor "enables both patients and physicians to monitor the daily limb lengthening progress." This describes a therapeutic and monitoring function, not a diagnostic one.
No
The device description clearly outlines hardware components including an "intramedullary limb lengthening system," "telescoping internal limb lengthening device," "titanium locking screws," "instrumentation," and an "external handheld Monitor." The performance studies also focus on biomechanical testing of the hardware.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- ISKD Function: The ISKD is an implantable mechanical device used for limb lengthening. It works by physically distracting bone tissue through controlled mechanical means.
- Lack of Specimen Analysis: The description clearly states the device is an internal implant that works through mechanical distraction and is monitored externally. There is no mention of analyzing any biological specimens from the patient.
The device description, intended use, and performance studies all point to a mechanical orthopedic device, not an IVD.
N/A
Intended Use / Indications for Use
The ISKD System intended for limb lengthening of the femur and tibia.
Product codes (comma separated list FDA assigned to the subject device)
HSB
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femur, tibia
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3020 Intramedullary fixation rod.
(a)
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.(b)
Classification. Class II.
0
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": |
| (Intramedullary Skeletal Kinetic | |
| Distractor) | |
| Classification Code(s): | 21 CFR Parts 888.3020 |
| Submitter's Name & Address: | Orthofix Inc. |
| 1720 Bray Central Drive | |
| McKinney, TX 75069 | |
| (469) 742-2561 | |
| Establishment Registration No: | 2183449 |
| Contact Person: | Mary Biggers, RAC |
| 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 |
| 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
page 3 of 3
| Features | ISKD 10.7mm | ISKD 12.5MM |
|---|---|---|
| Intended Use | "Limb lengthening of the tibia | |
| and femur" | "Limb lengthening of the tibia and | |
| femur" | ||
| MATERIAL | Ti6A14V ELI | Ti6A14V ELI |
| DESIGN FEATURES | Intramedullary nail | |
| Telescoping sections | ||
| One way clutch design | Intramedullary nail | |
| Telescoping sections | ||
| One way clutch design | ||
| METHOD OF | ||
| FIXATION | 4.0 mm & 4.8mm diameter | |
| locking screws | 4.8mm diameter locking screws | |
| NUMBER OF | ||
| FIXATION POINTS | 2 proximal/2 distal | 2 proximal/2 distal |
| DESIGN OF ENDS | Blunt | Blunt |
| CROSS | ||
| SECTIONAL SHAPE | Circular | Circular |
| RATE OF | ||
| LENGTHENING | Physician to determine rate. | |
| Dependent upon patient | ||
| activity level; .75-1.25 mm/day | Physician to determine rate. | |
| Dependent upon patient activity level; | ||
| .75-1.25 mm/day | ||
| CONTROL OF | ||
| LENGTHENING | Patient's activity level, i.e., | |
| rotational oscillations of the | ||
| limb | Patient's activity level, i.e., rotational | |
| oscillations of the limb | ||
| MONITORING OF | ||
| DISTRACTION | External hand held monitor; | |
| X-rays for confirmation | External hand held monitor; | |
| X-rays for confirmation | ||
| SAFETY FEATURES | Automatic stop when | |
| predetermined length is | ||
| achieved. And one-way clutch | ||
| design | Automatic stop when predetermined | |
| length is achieved. And one-way | ||
| clutch design | ||
| SIZE RANGES | ||
| (LENGTHS) | 10.5 (215-350mm) | 12.5 (255-435mm) |
| INVASIVE | ||
| COMPONENTS | Intramedullary limb lengthener, | |
| Locking screws | Intramedullary limb lengthener | |
| 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.
3
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.
4
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 (301) 594-4659. 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 (800) 638-2041 or (301) 443-6597 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
5
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