(71 days)
No
The device description details a purely mechanical external fixation system with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is used for external fixation of long bone fractures, which is a treatment for a medical condition.
No
Explanation: The device is described as an "external fixation device" used for the "management of bone fractures and reconstructive orthopedic surgery," which are therapeutic rather than diagnostic actions. It utilizes rods, clamps, and pins to stabilize bones, not to diagnose conditions.
No
The device description explicitly details physical components such as rods, clamps, and pins made of titanium, stainless steel, and carbon fiber, indicating it is a hardware-based medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "external fixation of open or closed long bone fractures." This is a surgical procedure performed directly on the patient's body to stabilize bones.
- Device Description: The device is comprised of physical components like rods, clamps, and pins, designed to be implanted or attached externally to the bone.
- Lack of IVD Characteristics: An IVD is a medical device intended for use in vitro (outside the body) for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The description of the AOS External Fixation System does not involve any of these activities.
Therefore, the AOS External Fixation System is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The AOS External Fixation System is indicated for external fixation of open or closed long bone fractures where soft tissue injury preclude the use of other fracture treatment. The AOS External Fixation System is intended to be non-weight bearing.
Product codes (comma separated list FDA assigned to the subject device)
KTT, JEC, JDW
Device Description
The AOS External Fixation System is an external fixation device comprised of rods, rod-to-rod clamps, pin-to-rod clamps and threaded pins used for the management of bone fractures and reconstructive orthopedic surgery. The system is a modular system designed to provide options in frame construction, simplicity in frame components, and ease of use. The system is comprised of titanium and stainless steel clamps (rod-to-rod and pin-to-rod), stainless steel fixation pins and carbon fiber connector rods. The AOS External Fixation system is a non-sterile single use fixation device. The rod-to-rod clamps are designed to clamp to the 9.5mm carbon fiber rod and connect two rods together. The rod-to-pin clamps are designed to clamp to the 9.5mm carbon fiber rod and to the 5.0mm stainless steel half pins and the 5.0mm shaft on the 6.0mm center threaded pin. The stainless steel threaded half pins are 5mm in diameter and in lengths of 180mm and 210mm. The stainless steel thread center pins have a 6.0mm thread diameter, 5.0mm shaft diameter and are 280mm in length. The 5.0mm threaded half pin and the center threaded pins have twist flutes so that they are self-drilling. The connecting rods are carbon fiber reinforced plastic rods with an overall diameter of 9.5mm and are in length of 250mm, 300mm and 400mm. The instrumentation for the system consists of a wrench, a pin inserter, a drill sheath and a 4.0mm calibrated drill.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
long bone fractures
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)
Not Found
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.
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
Image /page/0/Picture/1 description: The image shows the logo for Advanced Orthopaedic Solutions. The logo consists of the letters "AOS" in large, bold font, with the words "ADVANCED ORTHOPAEDIC SOLUTIONS" printed in a smaller font below. The logo is simple and professional, and it conveys the company's focus on providing advanced solutions for orthopaedic problems.
APR 2 5 2008
510(k) SUMMARY
| SUBBMITTED BY: | Advanced Orthopaedic Solutions
2444 205TH Street, Unit 5
Torrance, CA 90501
(310) 533-9966
FAX (310) 533-9876 |
|-------------------------------------|---------------------------------------------------------------------------------------------------------------------------|
| 510(k) CONTACT PERSON: | Paul Doner, Vice President Operations |
| TRADE NAME: | AOS External Fixation System |
| COMMON NAME: | External Fixation |
| CLASSIFICATION: | 21 CFR 888.3030 Single/multiple component
metallic bone fixation appliances and
accessories. |
| DEVICE CODE: | KTT |
| SUBSTANTIALLY
EQUIVALENT DEVICE: | Hoffman II External Fixation System (K053472)
Apex Fixation Pins (K011136) |
DEVICE DESCRIPTION AND SUBSTANTIAL EQUIVALENCE RATIONALES:
The AOS External Fixation System is an external fixation device comprised of rods, rod-torod clamps, pin-to-rod clamps and threaded pins used for the management of bone fractures and reconstructive orthopedic surgery.
The AOS External Fixation System is indicated for external fixation of open or closed long bone fractures where soft tissue injury preclude the use of other fracture treatment. The AOS External Fixation System is intended to be non-weight bearing.
The system is a modular system designed to provide options in frame construction, simplicity in frame components, and ease of use. The system is comprised of titanium and stainless steel clamps (rod-to-rod and pin-to-rod), stainless steel fixation pins and carbon fiber connector rods. The AOS External Fixation system is a non-sterile single use fixation device.
The rod-to-rod clamps are designed to clamp to the 9.5mm carbon fiber rod and connect two rods together. The rod-to-pin clamps are designed to clamp to the 9.5mm carbon fiber rod and to the 5.0mm stainless steel half pins and the 5.0mm shaft on the 6.0mm center threaded pin.
1
The stainless steel threaded half pins are 5mm in diameter and in lengths of 180mm and 210mm. The stainless steel thread center pins have a 6.0mm thread diameter, 5.0mm shaft diameter and are 280mm in length. The 5.0mm threaded half pin and the center threaded pins have twist flutes so that they are self-drilling.
The connecting rods are carbon fiber reinforced plastic rods with an overall diameter of 9.5mm and are in length of 250mm, 300mm and 400mm.
The surgical technique used for the AOS Eternal Fixation System is a standard method used for external fixation and is same as the technique used for the predicate devices. The instrumentation for the system consists of a wrench, a pin inserter, a drill sheath and a 4.0mm calibrated drill.
SUBSTANTIAL EQUIVALENCE INFORMATION:
Substantial equivalence for the AOS External Fixation System is based on the similarity in indication for use, design features, operating principles and material of composition to Stryker's Hoffman II Carbon Connecting Rods, K961916, Stryker's Hoffman III External Fixation System, K053472 and Stryker's Apex Fixation Pins, K011136.
The construct of the AOS External Fixation System and the predicate devices are virtually identical. Since the devices are substantially equivalent in design, geometry, construction, materials of construction and indications it was determined that no mechanical testing was necessary to demonstrate substantial equivalence.
INTENDED USE:
The AOS External Fixation System is indicated for external fixation of open or closed long bone fractures where soft tissue injury precludes the use of other fracture treatment.
The AOS External Fixation System is intended to be non-weight bearing,
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Advanced Orthopaedic Solutions % Mr. Paul Doner Vice President Operations 2444 205th Street, Unit 5 Torrance, CA 90501
APR 2 5 2008
Re: K080408 Trade/Device Name: AOS External Fixation System Regulation Number: 21 CFR 888.3030 Regulation Names: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: KTT, JEC, JDW Dated: February 12, 2008 Received: February 14, 2008
Dear Mr. Doner:
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 - Mr. Paul Doner
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark M. Milliman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Premarket Notification Indication for Use Statement
| 510(k) Number (if known): | K080408 |
|---|---|
| --------------------------- | --------- |
Device Name: AOS External Fixation System
Indications for Use:
The AOS External Fixation System is indicated for external fixation of open or closed long bone fractures where soft tissue injury precludes the use of other fracture treatment.
The AOS External Fixation System is intended to be non-weight bearing.
AND/OR Prescription Use: X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use: (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mitchel for mdm
(Division Sign-C Division of General, Restorative, and Neurological Devices
510(k) Number.
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