# K962757: J.B.S. Spine System with Pedicle Screws - Additional Components - Screws, Linking Plates, Hooks and Rod Clamp

- Pathway: 510(k) (Traditional)
- Applicant: J.B.S., S.A.
- Decided: Sep 25, 1996 after 71 days
- Product code: MNH (Orthosis, Spondylolisthesis Spinal Fixation)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
257 later devices descend from it; 3 cite it directly.
0 of 258 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) TSRH System by Sofamor Danek: named in the summary without a submission number
- (no number) PLSA System by Advanced Spine Fixation Systems: named in the summary without a submission number
- (no number) Rogozinsky System by Richards: named in the summary without a submission number
- (no number) Harrington System by Zimmer: named in the summary without a submission number
- (no number) C-D System by Stuart (Danek): named in the summary without a submission number

## Most influential descendants
- K982914: Aesculap Spine System Evolution: Additional Components (1998), 251 descendants of its own
- K980484: Aesculap Spine System Evolution (1998), 251 descendants of its own
- K990118: Isobar Spinal System (1999), 250 descendants of its own
- K061162: Bar Pedicle Screw Spinal Fixation System, Model 2020 (2006), 131 descendants of its own
- K092624: Firebird Spinal Fixation System (2009), 130 descendants of its own

## Indications for use
When usad asanon cervical hook and sacral screw system, the JB.S. Spine System is indicated for use in patients with degenerative disc disease wiously fafled back surgeries, and fractures. When used as a pedicle screw system, it is intended for patiens (a) having severe spondylolisthesis (grades 3 and 4) at the 1L5-S1 joint, who are receiving fusion using auogenous bone graft anly, (c) who are having the device fixed or attached to the lumber and sacral spine; and (d) who are having the device temoved after development of a solid fission mass. The JB.S. Spine System, as a whole, is infended for posterior fixation from levels T1 through S1. The Sacral Plates are intended for posterior sacral fixation atS1and S2. Levels of pedicle screw fixation are posterior fixation from levels L3 to through S1 only.

Source page: https://510kreport.com/device/K962757
Methodology: https://510kreport.com/methodology