# K160362: Z-Span Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Zavation, LLC
- Decided: Mar 22, 2016 after 42 days
- Product code: KWQ (Appliance, Fixation, Spinal Intervertebral Body)
- Device class: 2
- Regulation: 21 CFR 888.3060
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K990745 (1999). 39 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063158: Synthes Antegra System, Synthes Spine Co.Lp (2006) Summary page 5.
- K140260: Skyhawk Lateral Plate System, Orthofix, Inc. (2014) Summary page 5.

## Most influential descendants
- K162824: Z-Span Plate System (2017), 2 descendants of its own
- K202624: Z-Span Plate System (2020), 1 descendant of its own
- K230721: ATEC Lateral Plate System (2023), 0 descendants of its own

## Indications for use
The Z-Span Plate System is intended for use via the lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of the lumbar spine (L1-L5) or via the anterior approach below the bifurcation of the great vessels in the treatment of the lumbar and lumbosacral spine (L1-S1). The Z-Span Plate System is intended to provide immobilization and stabilization as an adjunct to fusion in skeletally mature patients in the treatment of the following: • Fracture (including dislocation and subluxation) • Tumor • Degenerative Disc Disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies) • Pseudoarthrosis • Spondylolysis • Spondylolisthesis • Scoliosis • Lordotic deformities of the spine • Spinal stenosis • Failed previous spine surgery

Source page: https://510kreport.com/device/K160362
Methodology: https://510kreport.com/methodology