# K123134: Easyspine System

- Pathway: 510(k) (Traditional)
- Applicant: Ldr Spine USA, Inc.
- Decided: Feb 1, 2013 after 119 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 K841189 (1984). 57 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 59 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043094: Easyspine System, Ldr Spine USA (2005) Summary page 1.
- K063794: Modification to Easyspine System, Ldr Spine USA (2007) Summary page 1.
- K082592: LDR Spine Easyspine System, Ldr Spine USA (2008) Summary page 1.
- K121103: LDR Spine Usa Spine Tune, TL Spinal System, LDR Spine Usa Easyspine, Posterior Spinal System, LDR Spine Usa MC Implant S, Ldr Spine USA, Inc. (2012) Summary page 1.
- K100952: Modification to Synthes Matrix System, Synthes Spine (2010) Summary page 1.
- K092929: Synthes Matrix System, Synthes (Usa) (2009) Summary page 1.

## Most influential descendants
- K231655: 4CIS® Chiron Spinal Fixation System (2024), 0 descendants of its own

## Indications for use
The Easyspine Posterior Spinal System is a posterior, non-cervical 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 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 * Pseudloarthrosis * Failed previous fusion

Source page: https://510kreport.com/device/K123134
Methodology: https://510kreport.com/methodology