# K043349: Open Radiotransparent Intersomatic Implant (Roi)

- Pathway: 510(k) (Traditional)
- Applicant: Ldr Spine USA
- Decided: Jun 29, 2005 after 205 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: 6 generations back to K841189 (1984). 14 ancestors in all.
134 later devices descend from it; 5 cite it directly.
0 of 149 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042268: Ebi Cas Spine Spacer System, Ebi, L.P. (2004) Summary page 1.
- K031757: Peek Tetris Spinal Implant, Signus Medical, LLC (2003) Summary page 1.
- K041888: Curved Peek Tetris Spinal Implant, Signus Medizintechnik GmbH (2004) Summary page 1.

## Most influential descendants
- K080572: LDR Spine Roi-a Implant (2008), 113 descendants of its own
- 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

## Indications for use
The ROI 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 may be implanted singularly or in pairs. Supplemental internal fixation is required to properly utilize this system.

Source page: https://510kreport.com/device/K043349
Methodology: https://510kreport.com/methodology