# K121922: Beacon Stabilization System

- Pathway: 510(k) (Special)
- Applicant: Globus Medical, Inc.
- Decided: Jul 26, 2012 after 24 days
- Product code: NKB (Thoracolumbosacral Pedicle Screw System)
- 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). 111 ancestors in all.
9 later devices descend from it; 1 cites it directly.
0 of 121 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073172: Beacon Stabilization System, Globus Medical, Inc. (2007) Summary page 1.
- K092610: Modification to Beacon Stabilization System, Globus Medical, Inc. (2009) Summary page 1.
- K100788: Cocr Rods, Globus Medical, Inc. (2010) Summary page 1.
- K113395: Revere 4.5 Stabilization System, Globus Medical, Inc. (2012) Summary page 1.
- K061202: Revere Stabilization System, Globus Medical, Inc. (2006) Summary page 1.
- K111449: Revolve Additional Implants, Globus Medical, Inc. (2011) Summary page 1.
- K082572: Uss Iliosacral, Uss Polyaxial, Synthes Spine (2008) Summary page 1.

## Most influential descendants
- K152148: Fortress Pedicular Fixation System (2015), 8 descendants of its own
- K160980: Threshold Pedicular Fixation System, Palisade Pedicular Fixation System (2016), 6 descendants of its own
- K161694: Threshold™ Pedicular Fixation System (2016), 3 descendants of its own
- K170266: Palisade™ Pedicular Fixation System (2017), 2 descendants of its own
- K171438: Palisade™ Pedicular Fixation System (2017), 1 descendant of its own

## Indications for use
The BEACON® Stabilization System, when used as a posterior pedicle screw 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 and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, pseudloarthrbsis and failed previous fusion. In addition, the BEACON® Stabilization System is intended for 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 lumbosacral spine and/or ilium with removal of the implants after attainment of a solid fusion. Levels of pedicle screw fixation for these patients are L3-sacrum/ilium. When used as a posterior non-pedicle screw fixation system (using REVERE® hooks), the BEACON® Stabilization System is intended for the treatment of degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, spondylolisthesis, spinal deformities (i.e. scoliosis, kyphosis, and/or lordosis, Scheuermann's disease), fracture, pseudloarthrosis, tumor resection, and/or failed previous fusion. Overall levels of fixation are Ti -sacrum/ilium. When used as an anterolateral thoracolumbar system, the BEACON® Stabilization System is intended for anterolateral screw (with or without staple) fixation for the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, spondylolisthesis, spinal deformities (i.e. scoliosis, kyphosis, and/or lordlosis), fracture or dislocation of the thoracolumbar spine, pseudloarthrosis, tumor resection, and/or failed previous fusion. Levels of screw fixation are T8-L5.

Source page: https://510kreport.com/device/K121922
Methodology: https://510kreport.com/methodology