# K110327: LDR Spine Roi-a Interbody Fusion System

- Pathway: 510(k) (Special)
- Applicant: Ldr Spine USA
- Decided: Sep 30, 2011 after 239 days
- Product code: OVD (Intervertebral Fusion Device With Integrated Fixation, Lumbar)
- Device class: 2
- Regulation: 21 CFR 888.3080
- 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 K082262 (2009). 2 ancestors in all.
241 later devices descend from it; 5 cite it directly.
0 of 244 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082262: LDR Spine Roi Interbody Fusion System, Ldr Spine USA (2009) Summary page 1.
- K090507: Modification to LDR Spine Roi Interbody Fusion System; Roi-a Implant System, Ldr Spine USA (2009) Summary page 1.

## Most influential descendants
- K113285: LDR Spine Usa Avenue L Interbody Fusion (2012), 199 descendants of its own
- K142645: Avenue T TLIF Cage (2015), 191 descendants of its own
- K153495: Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T Implant System (2016), 189 descendants of its own
- K162103: Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine Interbody Fusion System (Harrier™), Choice Spine Vertebral Body Replacement System (Hawkeye™) (2016), 161 descendants of its own
- K171686: Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) System (2017), 116 descendants of its own

## Indications for use
When used as an intervertebral body fusion device, the ROI-A 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. DDD 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.

Source page: https://510kreport.com/device/K110327
Methodology: https://510kreport.com/methodology