J.B.S. Implantable Spinal Fixation Device
by J.B.S., S.A. 510(k)
Active
510(k) K935113
Overview
The J.B.S. Implantable Spinal Fixation Device is a spinal interlaminal fixation orthosis designed to straighten and immobilize the spine. It consists of various hooks and a posteriorly placed compression or distraction rod made of an alloy such as stainless steel. The device is implanted across three adjacent vertebrae to facilitate the union and fusion of bone grafts.
This system is supplied as an assembly of non-sterile implantable devices. It has received FDA 510(k) clearance under K935113. Users should be aware of potential risks including vertebral fracture, loss of fixation, and neurological or vascular injury.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK935113 | Date19 Oct 1994 | 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- Withdrawn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
- KWP
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3050
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Other devices from J.B.S., S.A.
Questions
What is the primary clinical purpose of the J.B.S. Implantable Spinal Fixation Device?
This device is a spinal interlaminal fixation orthosis intended to straighten and immobilize the spine. It is specifically designed to be implanted across three adjacent vertebrae to facilitate the union and fusion of bone grafts.
How is the J.B.S. spinal system supplied to the facility?
The system is supplied as an assembly of non-sterile implantable components. Because the components are provided non-sterile, they must be processed according to the facility's established sterilization protocols prior to surgical implantation.
What materials are used in the construction of this fixation system?
The system consists of various hooks and a posteriorly placed compression or distraction rod. These components are manufactured from an alloy, such as stainless steel, chosen for its suitability in spinal fixation applications.
What are the known risks associated with the use of this device?
Users should be aware of potential clinical risks including vertebral fracture, loss of fixation, and the possibility of neurological or vascular injury. These factors should be carefully considered during the surgical planning and implantation process.
What is the regulatory status of this spinal fixation device?
The J.B.S. Implantable Spinal Fixation Device has received FDA 510(k) clearance under K935113. This indicates that the device has been determined to be substantially equivalent to legally marketed predicate devices.