Hoffmann II Compact MRI External Fixation System
510(k) K053038
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK053038 | Date22 Nov 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- Withdrawn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, 19 Sep 2026
The Hoffmann II Compact MRI External Fixation System is an orthopedic external fixation device designed for skeletal stabilization. It is classified as an external fixation system under the FDA’s orthopedic category, featuring modular metallic components for managing open or unstable fractures where internal fixation is contraindicated.
This system is intended for use in clinical settings, including MRI environments, as all components are MRI conditional. Supplied as a reusable device, it requires proper sterilization and storage per manufacturer guidelines. The system holds an FDA 510(k) clearance (K053038) under Special Review, with a decision date of November 22, 2005.
From the manufacturer
External fixation system allows for a variety of joint bridging and non-bridging frames with simple modular components. The modularity of the system allows the surgeon to adapt the frame to soft tissue complications and fracture pattern. A. System Approach to MRI All components in the system are designed for safety in the MRI environment.
Other devices from Howmedica Osteonics Corp.
Questions
AI-generated answers, 19 Sep 2026
Is the Hoffmann II Compact MRI External Fixation System safe to use in an MRI environment, and why does this matter for my clinical workflow?
Yes, the Hoffmann II Compact MRI External Fixation System is designed to be MRI conditional, meaning all its metallic components are safe for use in MRI environments without causing interference or posing risks to patients. This is critical for patients who may require both external fixation and MRI imaging—such as for soft tissue evaluation or follow-up—without the need for device removal or repositioning outside the scanner.
How is the Hoffmann II Compact MRI External Fixation System supplied, and what does this mean for my hospital’s inventory management?
The system is supplied as a reusable device, which means it must be properly sterilized between uses according to manufacturer guidelines. This approach reduces waste compared to single-use systems but requires your facility to allocate resources for sterilization, storage, and maintenance. The modular metallic components also allow for flexibility in assembling configurations for different patient needs.
What types of fractures or orthopedic conditions is this system intended to address, and how does its modular design benefit treatment?
The Hoffmann II Compact MRI External Fixation System is designed for skeletal stabilization in open or unstable fractures where internal fixation (e.g., plates or screws) is not feasible or advisable. Its modular metallic components enable customizable configurations to accommodate varying fracture patterns, limb sizes, and anatomical locations, providing precise alignment and load distribution during the healing process.
What regulatory pathway does this device follow, and what does the FDA’s Special Review classification imply for its use?
The Hoffmann II Compact MRI External Fixation System holds FDA 510(k) clearance (K053038) under Special Review, which indicates the FDA reviewed it with additional scrutiny due to its complexity or potential risks. This classification does not alter its intended use but signals that the device meets stringent standards for safety and effectiveness as an external fixation system under the orthopedic category (product code KTT). Clinically, this means it adheres to rigorous pre-market evaluation standards.