(127 days)
Not Found
No
The device description and intended use focus on mechanical distraction osteogenesis and do not mention any AI or ML components or functionalities.
Yes
The device is described as an implantable device for distraction osteogenesis techniques used to treat conditions for limb length deficiencies and deformities, which directly addresses a medical condition.
No
Explanation: The device is described as an "implantable device for distraction osteogenesis techniques in the femur" used to treat "limb length deficiencies." Its purpose is to physically lengthen a bone, not to detect, diagnose, or monitor a medical condition.
No
The device description clearly states it is an "implantable device" made of "stainless steel" with "two telescoping component bone plates" and a "threaded drive shaft." This describes a physical, hardware-based medical device, not a software-only device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The Inter-Os Limb Lengthener is an implantable device used for distraction osteogenesis techniques in the femur. It is a mechanical device that physically lengthens bone.
- Intended Use: The intended use is to treat limb length deficiencies by physically lengthening the bone, not by analyzing biological samples.
The description clearly indicates a surgical implant used for a mechanical procedure, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Inter-Os Limb Lengthener is an implantable device for distraction osteogenesis techniques in the femur. The Inter-Os Limb Lengthener is used to treat conditions for limb length deficiencies involving the femur. The types of deformities that fall into this category are: Traumatic deformities, growth deformities, deformities secondary to tumors and infections, and congenital deformities. The Inter-Os Limb Lengthener is intended to be used in the upper leg bones of the appendicular skeleton. The Limb Lengthener is not intended to be used for the spine. The Inter-Os Limb Lengthener is intended for single use and is not meant for repeat sterilization and implantation. The device is to be removed after consolidation of the bone is complete. It is to be used with other commercially-available accessory devices, such as bone screws for fixation to the bone surface. Bone cement is not to be used to fixate the device to the bone; however, commercially-available bone cement may be used on the undersurface of the device to level or stabilize it on a curved surface, or bone cement may also be used to fix the gear in position during the consolidation period.
Product codes
KTT
Device Description
The Inter-Os Limb Lengthener is an implantable device used to treat conditions where bone length is deficient. It is used for distraction osteogenesis techniques in the femur and is intended to be implanted by orthopedic surgeons. The device is removed after distraction is complete. It features two telescoping component bone plates that are distracted apart by a threaded drive shaft. Activation of the drive shaft is by means of a transcutaneous pin, which may be removed once the distraction phase is complete. The Activation Pin and the drive shaft are articulated using an internal gear. All of the components of the Inter-Os Limb Lengthener are fabricated from stainless steel. The Inter-Os Limb Lengthener is intended to be sold non-sterile. It is a single-use device. Sterilization instructions are included in the labeling.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femur, upper leg bones of the appendicular skeleton
Indicated Patient Age Range
Not Found
Intended User / Care Setting
orthopedic surgeons
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)
Performance has been substantiated by mechanical tests in conformity to standard testing guidelines for equivalent devices and literature review.
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.
K993869, K982222, K020872, K991941, K000083, K010437, K021031, K010322
Reference Device(s):
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
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
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.(b)
Classification. Class II.
0
OCT 2 2 2003
1.3 [510(k) Summary]
K031875 Page 1 of 2
Inter-Os Technologies, Inc. 7430 E. Park Meadows Drive, Suite 300 Lone Tree, CO 80124
Inter-Os Technologies, Inc. 7430 E. Park Meadows Drive, Suite 300 Lone Tree, CO 80124
Contact: Randolph C. Robinson, MD, DDS 303-708-8390 voice 303-790-7322 fax
Summary Prepared: May 15, 2003
Device Identification:
| Trade Name: | Inter-Os Limb Lengthener |
|---|---|
| Common Name: | Internal Bone Plate Distractor |
| Classification Name: | Single/Multiple component metallic bone fixation appliance and accessories, 21 CFR 888.3030 |
Product Description:
The Inter-Os Limb Lengthener is an implantable device used to treat conditions where bone length is deficient. It is used for distraction osteogenesis techniques in the femur and is intended to be implanted by orthopedic surgeons. The device is removed after distraction is complete. It features two telescoping component bone plates that are distracted apart by a threaded drive shaft. Activation of the drive shaft is by means of a transcutaneous pin, which may be removed once the distraction phase is complete. The Activation Pin and the drive shaft are articulated using an internal gear.
All of the components of the Inter-Os Limb Lengthener are fabricated from stainless steel. The Inter-Os Limb Lengthener is intended to be sold non-sterile. It is a singleuse device. Sterilization instructions are included in the labeling.
Indications for Use
The Inter-Os Limb Lengthener is an implantable device for distraction osteogenesis techniques in the femur. The Inter-Os Limb Lengthener is used to treat conditions for limb length deficiencies involving the femur. The types of deformities that fall into this category are:
Traumatic deformities, growth deformities, deformities secondary to tumors and infections, and congenital deformities.
The Inter-Os Limb Lengthener is intended to be used in the upper leg bones of the appendicular skeleton. The Limb Lengthener is not intended to be used for the spine.
1
KO31875 Page 2 of 2
The Inter-Os Limb Lengthener is intended for single use and is not meant for repeat sterilization and implantation. The device is to be removed after consolidation of the bone is complete. It is to be used with other commercially-available accessory devices, such as bone screws for fixation to the bone surface. Bone cement is not to be used to fixate the device to the bone; however, commercially-available bone cement may be used on the undersurface of the device to level or stabilize it on a curved surface, or bone cement may also be used to fix the gear in position during the consolidation period.
Predicate Devices
The Inter-Os Limb Lengthener is compared to the Inter-Os Bone Generator (#K993869), Synthes Fixation Plates (#K982222 and K020872), the EBI X-Fix DFS Rail System (#K991941, K000083, K010437, and K021031), the Orthofix/Orthodyne ISKD (#K010322) and others. We believe the Inter-Os device to be substantially equivalent based on the descriptive characteristics, same intended use, and same principle operation of distraction osteogenesis.
Performance has been substantiated by mechanical tests in conformity to standard testing guidelines for equivalent devices and literature review.
CONCLUSION
Based on the design, materials, function, intended use, the Inter-Os Limb Lengthener is substantially equivalent to the devices currently marketed under the Federal Food. Drug and Cosmetic Act. The Inter-Os Limb Lengthener raises no new safety or effectiveness issues. Therefore, safety and effectiveness are reasonably assured, justifying 510(k) clearance for commercial sale.
2
Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. The bottom half of the circle contains a stylized image of an eagle.
OCT 2 2 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Randolph C. Robinson, M.D., D.D.S. President Inter-Os Technologies, Inc. 7430 E. Park Meadows Drive, Suite 300 Lone Tree, CO 80124
Re: K031875
Trade/Device Name: Inter-Os Limb Lengthener Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: KTT Dated: September 2, 2003 Received: September 3, 2003
Dear Dr. Robinson:
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.
3
Page 2 - Randolph C. Robinson, M.D., D.D.S.
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 A. Melbernan
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
4
1.2 Indications Enclosure
Page 1 of 1
Pending K031875 510(k) Number:
Device Name:
Intended Uses/Indications
The Inter-Os Limb Lengthener is an implantable device for distraction osteogenesis techniques in the femur. The Inter-Os Limb Lengthener is used to treat conditions for limb length deficiencies involving the femur. The types of deformities that fall into this category are:
Traumatic deformities, growth deformities, deformities secondary to tumors and infections, and congenital deformities.
The Inter-Os Limb Lengthener is intended to be used in the upper leg bones of the appendicular skeleton. The Limb Lengthener is not intended to be used for the spine.
The Inter-Os Limb Lengthener is intended for single use and is not meant for repeat sterilization and implantation. The device is to be removed after consolidation of the bone is complete. It is to be used with other commercially-available accessory devices, such as bone screws for fixation to the bone surface. Bone cement is not to be used to fixate the device to the bone; however, commercially-available bone cement may be used on the undersurface of the device to level or stabilize it on a curved surface, or bone cement may also be used to fix the gear in position during the consolidation period.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) x Over-The-Counter Use
Mark V. Milkerson
ivision Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K03875