# K980928: Synthes Spine Universal Spinal Hook, Rod, Pedicle/Sacral Screw Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Synthes Spine
- Decided: May 11, 1998 after 61 days
- Product code: KWP (Appliance, Fixation, Spinal Interlaminal)
- Device class: 2
- Regulation: 21 CFR 888.3050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K964254 (1997). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964254: Titanium Liberty Posterior Spinal System, Sofamor Danek USA,Inc. (1997) Summary page 1.
- K970635: Titanium Spinal Rod System, Smith & Nephew, Inc., Orthopaedic Div. (1997) Summary page 1.

## Indications for use
When used as a posterior pedicle screw fixation system, the Synthes Universal Spinal Hook, Rod and Pedicle/Sacral Screw Fixation 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 mass. When used as a posterior, non-pedicle screw fixation system, the Universal Spinal Hook, Rod and Pedicle/Sacral Screw Fixation System is also intended for scoliotic, lordotic, or kyphotic deformities (such as scoliosis, Scheuermann’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 T4-S2). In addition, when using the parallel rod connector, the USS can be connected to the Posterior Cervical/Thoracic Hook/Rod System. The overall levels of fixation are T4-S2.

Source page: https://510kreport.com/device/K980928
Methodology: https://510kreport.com/methodology