# K111370: Odalys Pedicle Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Kalitec Direct, LLC
- Decided: Sep 21, 2011 after 128 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 K920116 (1992). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000536: Synthes Anterior CSLP System, Synthes Spine (2000) Summary page 1.
- K920116: PWB Lumbosacral Spine System, Cross Medical Products, Inc. (1992) Summary page 1.

## Most influential descendants
- K152098: ODALYS Pedicle Screw System (2015), 0 descendants of its own

## Indications for use
The ODALYS Pedicle Screw 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). As a pedicle screw system ODALYS Pedicle Screw System is indicated 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.

Source page: https://510kreport.com/device/K111370
Methodology: https://510kreport.com/methodology