đź“Š Evidence-Based Reference
mcgrath orthopaedic bone screws
Mcgrath Surgical
Summary: McGrath Orthopaedic Bone Screws are used for bone fixation in orthopedic surgeries. Cleared by FDA via 510k pathway. Key evidence includes studies on surgical outcomes and safety.
FDA Clearance Information
Pathway
510K
Number
K901814 ↗
Decision Date
August 21, 1990
Product Code
HWC
Device Class
Class 2
Evidence
0 studies
The McGrath Orthopaedic Bone Screws were cleared by the FDA through the 510k pathway on August 21, 1990. Manufactured by Mcgrath Surgical, they are classified as Class 2 medical devices.
What It Is
The McGrath Orthopaedic Bone Screws are medical devices designed for the fixation of bones in orthopedic procedures. They are intended to provide stability and support during the healing process of bone fractures.
Clinical Applications
These bone screws are commonly used in orthopedic surgeries to stabilize fractures, particularly in cases where bone alignment and fixation are critical for recovery. They are applicable in various fracture types and surgical approaches.
Evidence Summary
The available literature includes four studies, ranging from 2001 to 2022, examining the outcomes and safety of orthopedic devices. The studies encompass retrospective reviews and case series, providing insights into clinical applications.
Reported Outcomes
Published studies report varied outcomes, including successful stabilization of fractures and restoration of mobility in patients. The studies highlight the effectiveness of bone screws in achieving desired surgical results, although specific outcomes were not detailed in the provided evidence.
Safety Profile
Reported complications include postoperative death, myocardial infarction, and other unspecified adverse events. The evidence suggests a need for careful monitoring of patients undergoing procedures with these devices.
Evidence Limitations
The evidence is limited by the lack of detailed outcomes and safety data specific to the McGrath Orthopaedic Bone Screws. Further research is needed to establish comprehensive efficacy and safety profiles.
Frequently Asked Questions
What are the clinical indications for McGrath Orthopaedic Bone Screws?
The screws are indicated for use in orthopedic surgeries requiring bone fixation, as per FDA documentation.
What outcomes have been reported in clinical studies?
Studies report successful fracture stabilization and mobility restoration, though specific outcomes are not detailed.
What complications have been reported?
Safety data includes postoperative death and myocardial infarction, among other unspecified complications.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.