# K033826: Orthopedic Alliance Spine System

- Pathway: 510(k) (Traditional)
- Applicant: Orthopedic Alliance, LLC
- Decided: Jul 1, 2004 after 204 days
- Product code: MNI (Orthosis, Spinal Pedicle Fixation)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
135 later devices descend from it; 3 cite it directly.
0 of 136 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Xia Spinal System (Stryker Howmedica): named in the summary without a submission number
- (no number) Global Spinal Fixation System (U & I Corp.): named in the summary without a submission number
- (no number) Synergy Spine System (Interpore Cross): named in the summary without a submission number

## Most influential descendants
- K043484: Lanx Spinal Fixation System (2005), 77 descendants of its own
- K071877: Lanx Spinal Fixation System (2007), 75 descendants of its own
- K043094: Easyspine System (2005), 55 descendants of its own
- K061017: Easyspine System (2006), 50 descendants of its own
- K100354: Primal OK Interspinous Fusion System (2010), 37 descendants of its own

## Recalls of this device
- Mar 7, 2013 · Class II · Z-1156-2013: Orthopedic Alliance is recalling Blue & Gold Implants and Instruments because the Blue & Gold system is not supported by adequate testing and documentation to demonstrate that it meets performance or 

## Indications for use
The Orthopedic Alliance Spine 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 neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion ( pseudarthrosis ). The Orthopedic Alliance Spine System is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis ( grades 3 and 4 ) of the L5-SI 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/K033826
Methodology: https://510kreport.com/methodology