TempFix External Fixation System, MR Safe
510(k) K043113
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK043113 | Date21 Jan 2005 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- KTT
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3030
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 20 Sep 2026
The TempFix External Fixation System is a medical device classified as an external fixation device, designed to stabilize and support long bone fractures or correct bony and soft tissue deformities. It provides external skeletal fixation through a modular framework of pins, rods, and connectors, allowing for adjustable alignment and stabilization of fractured bones. The system is intended for both open and closed fractures, offering a non-invasive means of maintaining bone integrity during the healing process. Its modular design enables customization to fit various anatomical requirements and fracture patterns.
The TempFix External Fixation System is supplied as a reusable, modular orthopedic device intended for use in clinical settings such as hospitals and surgical centers. It is MRI-safe when used in accordance with specified guidelines, ensuring compatibility with magnetic resonance imaging procedures. The system is composed of stainless steel components and is designed for single-patient use before sterilization and reuse. Authorized under FDA 510(k) clearance (K043113), it adheres to regulatory standards for orthopedic fixation devices and is intended for non-weight-bearing applications unless supported by adjunctive devices.
Other devices from Depuy Orthopaedics, Inc.
Questions
AI-generated answers, 20 Sep 2026
What types of fractures or deformities is the TempFix External Fixation System designed to address, and how does its modular design help in treatment?
The TempFix External Fixation System is specifically designed to stabilize long bone fractures—both open and closed—and correct bony or soft tissue deformities. Its modular framework of pins, rods, and connectors allows for customizable alignment and stabilization, accommodating various fracture patterns and anatomical requirements. This adaptability ensures precise support during the healing process, making it versatile for different clinical scenarios.
Is the TempFix External Fixation System safe to use with MRI procedures, and what precautions should be taken if imaging is required?
Yes, the TempFix External Fixation System is labeled as MRI-safe when used according to specified guidelines. Since it is composed of stainless steel components, it is designed to be compatible with magnetic resonance imaging. However, clinicians should follow the manufacturer’s instructions to ensure proper positioning and imaging protocols to avoid interference or safety risks during MRI procedures.
How is the TempFix External Fixation System supplied, and what are the reuse and sterilization requirements?
The TempFix External Fixation System is supplied as a reusable, modular orthopedic device intended for single-patient use before sterilization and reuse. After use on one patient, components must be thoroughly cleaned and sterilized according to standard orthopedic device protocols to maintain safety and prevent cross-contamination. This ensures the system remains effective for subsequent clinical applications.
What materials are used in the TempFix External Fixation System, and how does this affect its durability and compatibility with other medical devices?
The TempFix External Fixation System is constructed from stainless steel components, which provide durability, strength, and corrosion resistance. This material choice ensures long-term structural integrity and compatibility with other orthopedic fixation devices, particularly when used in non-weight-bearing applications or supported by adjunctive devices as recommended.