# K963357: Modification to the Synthes (Usa) Universal Spinal Hook, Rod, and and Sacral Screw Fixation System in 316L Stainless Ste

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Jan 9, 1997 after 136 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.
No later device cites it as a predicate yet.
0 of 1 device 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) Synthes Universal Spinal Hook, Rod, and Pedicle/Sacral Screw Fixation System: named in the summary without a submission number
- (no number) Titanium TSRH Spinal System (Screws): named in the summary without a submission number
- (no number) Synthes Modular Spinal Fixation System: named in the summary without a submission number
- (no number) Locking Hook Spinal Rod System: named in the summary without a submission number

## Indications for use
When used as a pedicle screw system, the Synthes Universal Modular Spinal System is intended for patients with severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint (levels of screw fixation L3-S2); who are receiving fusions using autogenous bone graft only; who are having the device fixed or attached to the lumbar and sacral spine; and who are having the device removed after the development of a solid fusion. When used as a nonpedicle screw system, it is also intended for scoliotic, lordotic, or kyphotic deformities (such as scoliosis, Schueremann’s disease); degenerative disc disease as defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies; and fractures of the posterior thoracolumbar spine (levels T8-S2)

Source page: https://510kreport.com/device/K963357
Methodology: https://510kreport.com/methodology