← Product Code [LXT](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LXT) · K963432 # GUIDE WIRES FOR CANNULATED SCREWS (K963432) _Orthopaedic Biosystems, Ltd. · LXT · Nov 13, 1996 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LXT/K963432 ## Device Facts - **Applicant:** Orthopaedic Biosystems, Ltd. - **Product Code:** [LXT](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LXT.md) - **Decision Date:** Nov 13, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3030 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **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. ## Regulatory 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 ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} NOV-11-1996 14:22 JRTHUPRED.C BILLS 522 055 2152 7.22 NOV 13 1996 K963432 Guide Wires for Cannulated Screws 510(k)Summary - Safety and Effectiveness The proposed device, the guidewires for cannulated screws claims substantial equivalence to a currently marketed device, Synthes guidewires. The Synthes guidewires and the proposed device are available in either stainless steel or Titanium alloy. Both function in conjunction with a cannulated bone screw used as internal fixation for the carpel, tarsal, metatarsal, metacarpal, and phalanges of the hand and foot. There are no significant design differences. The tips of the guidewires are pointed with either a trocar or diamond point for starting into the bone. 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 510K-5.WPD Page 5 of 5 --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LXT/K963432](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/LXT/K963432) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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