# K080572: LDR Spine Roi-a Implant

- Pathway: 510(k) (Special)
- Applicant: Ldr Spine USA
- Decided: Apr 7, 2008 after 38 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: 7 generations back to K841189 (1984). 25 ancestors in all.
113 later devices descend from it; 1 cites it directly.
0 of 139 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043349: Open Radiotransparent Intersomatic Implant (Roi), Ldr Spine USA (2005) Summary page 1.
- K043479: MC+ Partial VBR, Ldr Spine USA (2005) Summary page 1.

## Most influential descendants
- K102402: Solus Anterior Lumbar Interbody Fusion (Alif) Spinal Spacer System (2011), 112 descendants of its own
- K182746: ATEC ALIF and LLIF Spacer System (2018), 110 descendants of its own
- K183705: IdentiTi Porous Ti Interbody System (2019), 99 descendants of its own
- K191311: ATEC Lateral Interbody System (2019), 78 descendants of its own
- K192938: Invictus™ Spinal Fixation System (2019), 69 descendants of its own

## Indications for use
The ROI-A 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 Ti to L5) and is intended for use with supplemental internal fixation. The ROI-A is intended to be implanted singularly. Supplemental internal fixation is required to properly utilize this system.

Source page: https://510kreport.com/device/K080572
Methodology: https://510kreport.com/methodology