J.B.S. Spine System with Pedicle Screws – Additional Components: Screws, Linking Plates, Hooks, and Rod Clamp
by J.B.S., S.A. 510(k)
Active
510(k) K962757
Overview
The J.B.S. Spine System with Pedicle Screws is a spinal fixation device designed for internal stabilization of the thoracolumbar and sacral spine. It consists of pedicle screws, linking plates, hooks, and rod clamps to construct a rigid assembly tailored to anatomical and physiological requirements. This modular system allows surgeons to address spinal pathologies through fusion adjuncts, providing mechanical support to the spine. The components are engineered to facilitate secure fixation and alignment during surgical interventions.
This system is supplied as a reusable surgical implant, intended for use in orthopedic procedures under sterile conditions. Components include screws, linking plates, hooks, and rod clamps, each designed for compatibility within the J.B.S. Spine System. The device is classified under product code MNH and holds FDA 510(k) clearance (K962757) as substantially equivalent to a predicate device, with approval granted in 1996. Storage and handling must adhere to manufacturer guidelines to maintain sterility and functionality.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK962757 | Date25 Sep 1996 | 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- Withdrawn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
- MNH
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3070
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Other devices from J.B.S., S.A.
Questions
What types of spinal procedures is the J.B.S. Spine System with Pedicle Screws designed to support, and how does its modularity benefit surgeons?
The J.B.S. Spine System is specifically designed for internal stabilization of the thoracolumbar and sacral spine, helping address spinal pathologies through fusion adjuncts. Its modularity allows surgeons to customize the assembly using pedicle screws, linking plates, hooks, and rod clamps, enabling tailored fixation and alignment based on the patient’s anatomy and surgical needs.
Is this device intended for single-use or reusable applications, and what considerations should be taken for sterility during use?
The J.B.S. Spine System is classified as a reusable surgical implant, meaning it is intended for multiple uses under sterile conditions. To maintain sterility and functionality, storage and handling must strictly follow the manufacturer’s guidelines, as improper care could compromise the device’s integrity for subsequent procedures.
What regulatory pathway was followed for FDA clearance of this device, and when was it originally approved?
The J.B.S. Spine System received FDA 510(k) clearance under the traditional review pathway, demonstrating substantial equivalence to a predicate device. The clearance was granted on September 25, 1996, with the submission filed on July 16, 1996, and the product code assigned as MNH.
Are there different sizes or models available for this system, and how does this affect surgical planning?
While the provided data does not specify exact sizes or model variations, the J.B.S. Spine System is designed as a modular assembly with components like screws, plates, hooks, and clamps tailored to anatomical requirements. This modularity allows surgeons to select appropriate parts for each patient, ensuring precise fixation and alignment during thoracolumbar or sacral spine procedures.