# K963045: Synthes (U.S.a.) Universal Sacral System

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Feb 13, 1997 after 192 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.
662 later devices descend from it; 11 cite it directly.
2 of 663 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) SYNTHES (U.S.A.) Universal Spinal Hook, Rod and Pedicle/Sacral Screw Fixation System Side Opening Screw and the Transverse Bar: named in the summary without a submission number
- (no number) Texas Scottish Rite Hospital (TSRH) Variable Angle Screw: named in the summary without a submission number

## Most influential descendants
- K082572: Uss Iliosacral, Uss Polyaxial (2008), 659 descendants of its own
- K091445: CD Horizon Spinal System (2010), 581 descendants of its own
- K082914: Clampfix (2008), 350 descendants of its own
- K090605: Clampfix (2009), 349 descendants of its own
- K103287: Synthes 6.0 Cocr and CPT TI-3 Rods (2011), 348 descendants of its own

## Indications for use
When used as a posterior pedicle screw fixation system, the SYNTHES Universal Sacral System is intended for patients with severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; 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 posterior, non-pedicle screw fixation system, the SYNTHES Universal Sacral System is also intended for scoliotic, lordotic, or kyphotic deformities (such as scoliosis, Schueremann’s disease); degenerative disk disease (back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), and fractures of the posterior thoracolumbar spine (levels T8-S2).

Source page: https://510kreport.com/device/K963045
Methodology: https://510kreport.com/methodology