# K121103: LDR Spine Usa Spine Tune, TL Spinal System, LDR Spine Usa Easyspine, Posterior Spinal System, LDR Spine Usa MC Implant S

- Pathway: 510(k) (Traditional)
- Applicant: Ldr Spine USA, Inc.
- Decided: Aug 24, 2012 after 135 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: 10 generations back to K841189 (1984). 38 ancestors in all.
16 later devices descend from it; 4 cite it directly.
0 of 55 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 1.
- K063794: Modification to Easyspine System, Ldr Spine USA (2007) Summary page 1.
- K070341: LDR Spine Easyspine Posterior Osteosynthesis System, Ldr Spine USA (2007) Summary page 1.
- K082592: LDR Spine Easyspine System, Ldr Spine USA (2008) Summary page 1.
- K043349: Open Radiotransparent Intersomatic Implant (Roi), Ldr Spine USA (2005) Summary page 1.
- K091088: LDR Spine Cervical Interbody Fusion System, Ldr Spine USA (2009) Summary page 1.
- K082262: LDR Spine Roi Interbody Fusion System, Ldr Spine USA (2009) Summary page 2.
- K090507: Modification to LDR Spine Roi Interbody Fusion System; Roi-a Implant System, Ldr Spine USA (2009) Summary page 2.

## Most influential descendants
- 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
- K172320: Neurostructures Cavetto® Cervical Cage System (2018), 3 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 * Deform~ities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis) * Tumor *Pseudloarthrosis * Failed previous fusion When used as an intervertebral body fusion device, the MC+ Implant System is indicated for use in skeletally mature patients with degenerative disc disease (ODD) of the cervical spine with accompanying radicular symptoms at one disc level from 02-Ti. DIDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of nonoperative treatment prior to treatment with the device. The MC+ Implant System is to be used with autogenous bone graft and implanted via an open, anterior approach. Supplemental fixation is required to properly utilize this system. When used as a vertebral body replacement device, the MC+ Implant System is indicated for use to replace a vertebral body that has been resected or excised due to tumor or trauma/fracture. The device is intended for use as a partial vertebral body replacement in the thoracolumbar spine (from Ti to L5) and is intended for use with supplemental internal fixation. Supplemental internal fixation is required to properly utilize this system. These devices are intended to be used with autograft or allograft bone. The ROI Partial Vertebral Body Replacement System is indicated for use to replace a vertebral body that has been resected or excised due to tumor or trauma/fracture. The device is intended for use as a partial vertebral body replacement in the thoracolumbar spine (from Ti to L5) and is intended for use with supplemental fixation. ROI Partial Vertebral Body Replacement implants may be implanted singularly or in pairs. Supplemental internal fixation is required to properly utilize the system. When used as an intervertebral body fusion device, the ROI- Implant System is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDID is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion. The ROI-C Implant System is indicated for use in skeletally mature patients with degenerative disc disease (ODD) of the cervical spine with accompanying radicular symptoms at one disc level from C2-T1. DDOD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The LOR Spine ROI-C Implant System is to be used with autogenous bone graft and implanted via an open, anterior approach. Supplemental internal fixation is required to properly utilize this system. When used as an intervertebral body fusion device, the ROI-T Implant System is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one or two contiguous levels for the treatment of degenerative disc disease (ODD) with up to Grade I spondylolisthesis. DD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion. When used as a-vertebral body replacement device, the ROI-T Implant System is indicated for use to replace a vertebral body that has been resected or excised due to tumor or trauma/fracture. The device is intended for use as a partial vertebral body replacement in the thoracolumbar spine (from Ti to L5) and is intended for use with supplemental fixation. Supplemental internal fixation is required to properly utilize the system. These devices are intended to be used with autograft or allograft bone. The RO/-T implants may be implanted singularly or in pairs.

Source page: https://510kreport.com/device/K121103
Methodology: https://510kreport.com/methodology