# K153404: Zavation Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Zavation, LLC
- Decided: Apr 21, 2016 after 149 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
Longest line of descent: 11 generations back to K040583 (2004). 202 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 204 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112484: Zavation Spinal System, Zavation, LLC (2011) Summary page 5.
- K955348: Titanium Moss Miami Spinal System, Depuy, Inc. (1996) Summary page 5.
- K024096: Optima, Spinal System, U&I Corp., America (2003) Summary page 5.
- K000236: Synergy VLS Cap Nut Models 2206, 6102, Interpore Cross Intl. (2000) Summary page 5.
- K120838: Synthes Matrix System, Synthes Spine (2012) Summary page 5.

## Most influential descendants
- 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 pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-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/K153404
Methodology: https://510kreport.com/methodology