(76 days)
None
Not Found
No
The device description and intended use focus on mechanical components for external fixation and do not mention any software, algorithms, or data processing capabilities that would indicate the use of AI/ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
Yes
The device is used to externally bridge a fracture or non-union of a long bone to provide a stable environment for healing, which is a therapeutic function.
No
This device is described as a clamping mechanism for external fixation of long bone fractures, intended to provide stability for healing. It does not mention any function related to diagnosing a condition or disease.
No
The device description explicitly mentions physical components like stainless steel pins, carbon-fiber tubes, and clamps, indicating it is a hardware-based medical device.
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, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Description and Intended Use: The provided description clearly states that this device is a clamping mechanism used to externally bridge a fracture or non-union of a long-bone. It involves inserting pins into the bone and using clamps and rods to stabilize the fracture within the body.
This device is a surgical implant/external fixation device, not a diagnostic tool that analyzes biological samples.
N/A
Intended Use / Indications for Use
This product is intended for use as a clamping mechanism between a group of percutaneous Schanz type pins and connecting rods. A minimum of four of these clamps combined with percutaneous pins and connecting rods would be used to externally bridge a fracture or non-union of a long-bone to provide a more stable environment for soft tissue and/or bone healing to occur.
Indications for use include: fracture fixation(open and closed); pseudarthrosis or long bones (both congenital and acquired); limb lengthening by epiphyseal or metaphyseal distraction; correction of bony or soft tissue deformities; correction of osteotomies; and correction of bony or soft tissue defects.
Product codes
Not Found
Device Description
The product consists of AISI 316L stainless steel pins inserted above and below the fracture site. The carbon-fiber tubes in combination with pin clamps act to hold the transfixation pins at the desires angle and position. Bar-bar clamps are used to combine additional carbon fiber tubes in the desired configuration
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
long-bone (fracture or non-union)
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Hex-Fix External Fixation by Smith and Nephew Richards, Day External Fixation by DePuy, AP/ASIF External Fixation System by Synthes
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
510(K) Summary of Safety and Effectiveness
R960014
| Submitter: | Orthopaedic Innovations, Inc.
825 South 8th Street, Suite 700
Minneapolis, MN 55404
Telephone: (612) 672-0021
Contact: Carolyn M. Steele | Date of Summary: | 12/28/95
MAR 18 1996 |
|------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|-------------------------|
| Product: | Classification Name: | Single/multiple component metallic bone fixation appliances and accessories - (21 CFR 88.3030) | |
| | Common Name: | External Fixation System | |
| | Trade/Proprietary Name: | Practifix External Fixation System | |
| Substantially Equivalent Products | Hex-Fix External Fixation by Smith and Nephew Richards
Day External Fixation by DePuy
AP/ASIF External Fixation System by Synthes | | |
| Description | The product consists of AISI 316L stainless steel pins inserted above and below the fracture site. The carbon-fiber tubes in combination with pin clamps act to hold the transfixation pins at the desires angle and position. Bar-bar clamps are used to combine additional carbon fiber tubes in the desired configuration | | |
| Intended Use: | This product is intended for use as a clamping mechanism between a group of percutaneous Schanz type pins and connecting rods. A minimum of four of these clamps combined with percutaneous pins and connecting rods would be used to externally bridge a fracture or non-union of a long-bone to provide a more stable environment for soft tissue and/or bone healing to occur. | | |
| | Indications for use include: fracture fixation(open and closed); pseudarthrosis or long bones (both congenital and acquired); limb lengthening by epiphyseal or metaphyseal distraction; correction of bony or soft tissue deformities; correction of osteotomies; and correction of bony or soft tissue defects. | | |
| Comparison to Substantial Equivalent Products: | All made of the same types of materials, equivalent in function and design. | | |
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