# K073439: Transition Stabilization System

- Pathway: 510(k) (Traditional)
- Applicant: Globus Medical, Inc.
- Decided: Feb 20, 2009 after 441 days
- Product code: NQP (Posterior Metal/Polymer Spinal System, Fusion)
- 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: 5 generations back to K990745 (1999). 14 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061202: Revere Stabilization System, Globus Medical, Inc. (2006) Summary page 1.
- K031511: Dynesys Spinal System, Centerpulse Spine-Tech, Inc. (2004) Summary page 1.

## Most influential descendants
- K133153: Spinefrontier Pedfuse Pedicle Screw System (2014), 1 descendant of its own
- K143377: PedFuse Pedicle Screw System (2015), 0 descendants of its own

## Indications for use
The TRANSITION TM Stabilization System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine in skeletally mature patients: degenerative spondylolisthesis with objective evidence of neurologic impairment, kyphosis, and failed previous fusion (pseudoarthrosis). In addition, the TRANSITION TM Stabilization System is indicated for use in patients: who are receiving fusions with autogenous graft only; who are having the device fixed or attached to the lumbar or sacral spine; and who are having the device removed after the development of a solid fusion mass. TRANSITION TM is only indicated for use when fusion with autogenous bone graft is being performed at all instrumented levels.

Source page: https://510kreport.com/device/K073439
Methodology: https://510kreport.com/methodology