# K133366: Orthros Posterior Stabilization System

- Pathway: 510(k) (Traditional)
- Applicant: Camber Spine
- Decided: Apr 8, 2014 after 158 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: 15 generations back to K853033 (1985). 201 ancestors in all.
2 later devices descend 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)
- K121728: Tiger Spine System, Corelink, LLC (2012) Summary page 1.
- K061202: Revere Stabilization System, Globus Medical, Inc. (2006)
- K124058: Creo Stabilization System, Globus Medical, Inc. (2013) Summary page 1.
- K113395: Revere 4.5 Stabilization System, Globus Medical, Inc. (2012) Summary page 1.
- K052151: Synthes Pangea Monoaxial System, Synthes Spine Co.Lp (2005) Summary page 1.

## Most influential descendants
- K180980: ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization System (2018), 1 descendant of its own
- K220038: Camber Spine Navigation System (2022), 0 descendants of its own

## Indications for use
Orthros Posterior Stabilization 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 thoracic, lumbar, and sacral/iliac spine (TI-SI/Ilium): degenerative disc disease (defined as discogenic back pain with degeneration of disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation. scoliosis, kyphosis. spinal tumor, and failed previous fusion (pseudaxthrosis). In addition, Orthros Posterior Stabilization System is intended for treatment of severe spondylolisthesis (Grades 3 and 4) of the 1--S I 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.

Source page: https://510kreport.com/device/K133366
Methodology: https://510kreport.com/methodology