EBI XFIX Access Pelvic Fixator
by Ebi, L.P. 510(k)
Active
510(k) K013540
Overview
The EBI XFIX Access Pelvic Fixator is a unilateral external fixation device classified under the product code KTT. It is designed for orthopedic applications, including the stabilization of pelvic fractures, bone lengthening, osteotomies, arthrodesis, and fracture fixation. This device provides external skeletal fixation to support bone alignment and healing in complex pelvic conditions.
This device is supplied as a reusable medical instrument and has received FDA 510(k) clearance under the Special 510(k) pathway. It is intended for use in orthopedic settings and adheres to regulatory standards for Class 2 orthopedic devices. The fixator is intended for surgical use and must be handled and stored according to sterile medical instrument protocols. No additional regulatory approvals beyond the stated 510(k) clearance are mentioned.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK013540 | Date20 Nov 2001 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
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
Other devices from Ebi, L.P.
Questions
What is the EBI XFIX Access Pelvic Fixator used for?
The EBI XFIX Access Pelvic Fixator is designed for orthopedic applications, including the stabilization of pelvic fractures, bone lengthening procedures, osteotomies, arthrodesis, and fracture fixation. It provides external skeletal fixation to support proper bone alignment and promote healing in complex pelvic conditions by applying controlled forces externally.
Is the EBI XFIX Access Pelvic Fixator reusable or single-use?
The EBI XFIX Access Pelvic Fixator is supplied as a reusable medical instrument. Like other reusable orthopedic devices, it must be thoroughly cleaned, disinfected, and sterilized between uses to maintain safety and prevent infection, following strict sterile medical instrument protocols.
What regulatory clearance does this device have?
This device has received FDA 510(k) clearance under the Special 510(k) pathway, specifically classified under product code KTT for external fixation devices. The clearance confirms it meets regulatory standards for Class 2 orthopedic instruments and is authorized for surgical use in orthopedic settings.
How should the EBI XFIX Access Pelvic Fixator be stored?
Since this is a reusable surgical instrument, it must be stored in a clean, dry environment to prevent contamination. After each use, it should undergo proper cleaning, disinfection, and sterilization before storage. Follow manufacturer guidelines and facility protocols to ensure sterility and functionality for subsequent procedures.
What types of pelvic conditions does this fixator address?
The EBI XFIX Access Pelvic Fixator is intended for complex pelvic conditions requiring external stabilization, such as unstable pelvic fractures, deformity corrections via osteotomies, and arthrodesis (joint fusion). Its unilateral design allows targeted support for bone alignment and healing in these orthopedic applications.