# K043094: Easyspine System

- Pathway: 510(k) (Traditional)
- Applicant: Ldr Spine USA
- Decided: Feb 11, 2005 after 94 days
- Product code: MNI (Orthosis, Spinal Pedicle 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 K033826 (2004). 1 ancestor in all.
55 later devices descend from it; 6 cite it directly.
0 of 57 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033826: Orthopedic Alliance Spine System, Orthopedic Alliance, LLC (2004) Summary page 1.

## Most influential descendants
- K061017: Easyspine System (2006), 50 descendants of its own
- K141873: Range/Mesa/Denali Spinal System (2014), 30 descendants of its own
- K082592: LDR Spine Easyspine System (2008), 20 descendants of its own
- K070341: LDR Spine Easyspine Posterior Osteosynthesis System (2007), 17 descendants of its own
- K063794: Modification to Easyspine System (2007), 17 descendants of its own

## Indications for use
The LDR Easyspine System is a posterior, noncervical, pedicle 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: spondylolisthesis (grades 3 and 4 at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment), trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

Source page: https://510kreport.com/device/K043094
Methodology: https://510kreport.com/methodology