# K082592: LDR Spine Easyspine System

- Pathway: 510(k) (Special)
- Applicant: Ldr Spine USA
- Decided: Oct 8, 2008 after 30 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: 2 generations back to K033826 (2004). 2 ancestors in all.
20 later devices descend from it; 4 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043094: Easyspine System, Ldr Spine USA (2005) Summary page 2.

## Most influential descendants
- K121103: LDR Spine Usa Spine Tune, TL Spinal System, LDR Spine Usa Easyspine, Posterior Spinal System, LDR Spine Usa MC Implant S (2012), 16 descendants of its own
- K141129: Exactech Cervical Spacer System (2014), 8 descendants of its own
- K150130: Ascendant TM Cervical Spacer System (2015), 7 descendants of its own
- K191621: ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer System Ascendant PC, ChoiceSpine Cervical Interbody Spacer System Ascendant, ChoiceSpine Cervical Spacer System Blackhawk, ChoiceSpine Intervertebral Fusion Device Octane Straight, ChoiceSpine Intervertebral Fusion Device Octane Straight PC, ChoiceSpine VEO Laterial Access & Interbody Fusion System (2019), 4 descendants of its own
- K203311: ChoiceSpine Blackhawk Ti Cervical Spacer System (2021), 3 descendants of its own

## Indications for use
The LDR Easyspine System is a posterior, noncervical pedicle and non-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: * Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) * Spondylolisthesis * Trauma (i.e. fracture or dislocation) * Spinal stenosis * Deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis) * Tumor * Pseudoarthrosis * Failed previous fusion

Source page: https://510kreport.com/device/K082592
Methodology: https://510kreport.com/methodology