# K112484: Zavation Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Zavation, LLC
- Decided: Nov 22, 2011 after 85 days
- Product code: MNI (Orthosis, Spinal Pedicle 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
Longest line of descent: 1 generation back to K955348 (1996). 2 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K955348: Titanium Moss Miami Spinal System, Depuy, Inc. (1996) Summary page 2.
- K033901: Merlin Spine System, Depuy Spine, Inc. (2004) Summary page 2.

## Most influential descendants
- K202624: Z-Span Plate System (2020), 1 descendant of its own
- K153404: Zavation Spinal System (2016), 1 descendant of its own
- K231811: Zavation Connector System (2023), 0 descendants of its own
- K230721: ATEC Lateral Plate System (2023), 0 descendants of its own
- K190361: Zavation Spinal System (2019), 0 descendants of its own

## Indications for use
The Zavation Spinal System is a pedicle screw system intended to provide Immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The Zavation Spinal Systems is also indicated for pedlicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) of the LS-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. The Zavation Spinal Systems when used as anterior thoracic/lumbar screw fixation systems, is indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis).

Source page: https://510kreport.com/device/K112484
Methodology: https://510kreport.com/methodology