GUIDE WIRES FOR CANNULATED SCREWS
Device Facts
| Record ID | K963432 |
|---|---|
| Device Name | GUIDE WIRES FOR CANNULATED SCREWS |
| Applicant | Orthopaedic Biosystems, Ltd. |
| Product Code | LXT · Orthopedic |
| Decision Date | Nov 13, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 888.3030 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The guidewires for cannulated screws are used as internal fixation for the carpel, tarsal, metatarsal, metacarpal, and phalanges of the hand and foot. The wires are normally used as temporary fixation of a fracture or osteotomy site until a bone screw can be driven over the wire and the wire removed.
Device Story
Guidewires for cannulated screws; stainless steel or titanium alloy construction; pointed tips (trocar or diamond) for bone entry. Used in orthopedic surgery for hand and foot fractures/osteotomies. Function: temporary fixation of bone segments; guide path for cannulated screw insertion. Procedure: wire inserted into bone; cannulated screw driven over wire; wire removed. Operated by orthopedic surgeons in clinical/OR settings. Benefit: facilitates accurate placement of cannulated screws for internal fixation.
Clinical Evidence
No clinical data; bench testing only.
Technological Characteristics
Materials: stainless steel or titanium alloy. Design: guidewire with pointed trocar or diamond tip. Function: temporary bone fixation and cannulated screw guidance. Sterilization: not specified.
Indications for Use
Indicated for temporary fixation of fractures or osteotomies of the carpel, tarsal, metatarsal, metacarpal, and phalanges of the hand and foot, serving as a guide for cannulated bone screws.
Regulatory Classification
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.
Predicate Devices
- Synthes guidewires
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