# K080569: LDR Spine Roi-T Implant

- Pathway: 510(k) (Special)
- Applicant: Ldr Spine USA
- Decided: May 7, 2008 after 68 days
- Product code: MQP (Spinal Vertebral Body Replacement Device)
- Device class: 2
- Regulation: 21 CFR 888.3060
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K841189 (1984). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072132: LDR Spine Roi-T System, Ldr Spine USA (2007) Summary page 1.
- K043349: Open Radiotransparent Intersomatic Implant (Roi), Ldr Spine USA (2005) Summary page 1.

## Indications for use
The ROI-T Implant 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 T1 to L5) and is intended for use with supplemental internal fixation. The ROI-T may be implanted singularly or in pairs. Supplemental internal fixation is required to properly utilize this system.

Source page: https://510kreport.com/device/K080569
Methodology: https://510kreport.com/methodology