(32 days)
No
The description focuses on the materials and mechanical function of external fixation components, with no mention of AI or ML.
Yes
The device is used for fracture fixation, limb lengthening, and correction of bony deformities, all of which are therapeutic interventions.
Yes
The text explicitly states that "Titanium washers are intended to be used for fixation to distribute the load of the wire with stopper, for the diagnostic indications of osteoporotic bone" and "These components as part of the Ilizarov External Fixator System are for the diagnostic indications of fractures, pseudoarthrosis and correction of segmental or nonsegmental bony or soft tissue deformities."
No
The device description explicitly details physical components (titanium washers and wires) that are part of an external fixator system, indicating it is a hardware device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The description clearly states that this device is part of an Ilizarov External Fixator System. This system is used for surgical procedures involving bone fixation, limb lengthening, and deformity correction. It is an implantable or external mechanical device used directly on the patient's body.
- Intended Use: The intended uses listed (fracture fixation, limb lengthening, deformity correction) are all clinical procedures performed on the patient, not laboratory tests on samples.
- Lack of IVD Characteristics: The text does not mention any analysis of biological samples, diagnostic reagents, or laboratory procedures, which are hallmarks of IVDs.
Therefore, the device described is a surgical implant/external fixation system, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The titanium washers and titanium wires of the Ilizarov External Fixation System are single use devices designed for patients with the following indications: open and closed fracture fixation, pseudoarthrosis or nonunions of long bones, limb lengthening by epiphyseal distraction, correction of bony or soft tissue deformities, and correction of bony or soft tissue defects. Titanium washers are intended to be used for fixation to distribute the load of the wire with stopper, for the diagnostic indications of osteoporotic bone. These components as part of the Ilizarov External Fixator System are for the diagnostic indications of fractures, pseudoarthrosis and correction of segmental or nonsegmental bony or soft tissue deformities
Product codes
Not Found
Device Description
The titanium wires and washers have the same function as the existing stainless steel wires and washers. They are made of titanium for patients who have a sensitivity to stainless steel. The titanium components are primarily for patients that have allergy sensitivities.
The washer and wires interconnect with the Ilizarov External Fixator System. The wires are inserted and attached to the rings of the circular fixator and rods of the Ilizarov External Fixator System. The wires are available with an olive shaped stopper to create interfragmentary compression or to add more stability to the assemblage. The washer may be used with the wires with stopper to provide surface area for the stopper to push up against.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
long bones
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
The testing of these devices centered primarily on the following parameters: fatigue testing of the titanium wires. The results were acceptable and the titanium wire should perform as well as the stainless steel wire.
Key Metrics
Not Found
Predicate Device(s)
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
AUG 19 1996
Image /page/0/Picture/1 description: The image shows a handwritten sequence of characters. The sequence starts with the letter 'K', followed by the numbers '962808'. The characters are written in a bold, somewhat messy style, giving them a distinct, hand-drawn appearance.
Summary of Safety and Effectiveness
Smith & Nephew Orthopaedics
Ilizarov External Fixation System - Titanium Washers, Titanium Wires, and Titanium Wires with Olive Shaped Stopper
The titanium washers and titanium wires of the Ilizarov External Fixation System are single use devices designed for patients with the following indications: open and closed fracture fixation, pseudoarthrosis or nonunions of long bones, limb lengthening by epiphyseal distraction, correction of bony or soft tissue deformities, and correction of bony or soft tissue defects. Titanium washers are intended to be used for fixation to distribute the load of the wire with stopper, for the diagnostic indications of osteoporotic bone. These components as part of the Ilizarov External Fixator System are for the diagnostic indications of fractures, pseudoarthrosis and correction of segmental or nonsegmental bony or soft tissue deformities
The titanium wires and washers have the same function as the existing stainless steel wires and washers. They are made of titanium for patients who have a sensitivity to stainless steel. The titanium components are primarily for patients that have allergy sensitivities.
The washer and wires interconnect with the Ilizarov External Fixator System. The wires are inserted and attached to the rings of the circular fixator and rods of the Ilizarov External Fixator System. The wires are available with an olive shaped stopper to create interfragmentary compression or to add more stability to the assemblage. The washer may be used with the wires with stopper to provide surface area for the stopper to push up against.
The testing of these devices centered primarily on the following parameters: fatigue testing of the titanium wires. The results were acceptable and the titanium wire should perform as well as the stainless steel wire.