# K102636: Zenith Pedicle System

- Pathway: 510(k) (Traditional)
- Applicant: Apollo Spine, Inc.
- Decided: Mar 3, 2011 after 171 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: 1 generation back to K013823 (2001). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013823: Xia Spinal System, Howmedica Osteonics Corp. (2001) Summary page 1.

## Cited in the summary but kept off the family tree
- K07343: Amedica Valeo Pedicle Screw System. Number could not be read Summary page 1.

## Indications for use
The Zenith Pedicle System is 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 arid chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, trauma (i.e., fracture or dislocation), deformities or curvatures ( i.e., scoliosis, kyphosis. and/or lordosis), spinal tumor, and failed previous fusion (pseudarthrosis). In addition, this device is a pedicle screw system indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S I vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3-SI) with removal of implants after the attainment of a solid fusion.

Source page: https://510kreport.com/device/K102636
Methodology: https://510kreport.com/methodology