# K080728: LDR Spine Roi-C Implant

- Pathway: 510(k) (Special)
- Applicant: Ldr Spine USA
- Decided: May 29, 2008 after 76 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). 23 ancestors in all.
903 later devices descend from it; 1 cites it directly.
1 of 927 devices in its family (counting itself) has a Class I recall.

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

## Most influential descendants
- K083857: LDR Spine Roi-C Implant (2009), 902 descendants of its own
- K091088: LDR Spine Cervical Interbody Fusion System (2009), 901 descendants of its own
- K123206: Maxim Surgical X-Treme Interbody Fusion System (2013), 454 descendants of its own
- K140003: Coroent Small Interbody System (2014), 453 descendants of its own
- K142050: Nuvasive Coroent Small Contoured Interbody System (2014), 449 descendants of its own

## Indications for use
The ROI-C 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-C is intended to be implanted in pairs. Supplemental internal fixation is required to properly utilize this system.

Source page: https://510kreport.com/device/K080728
Methodology: https://510kreport.com/methodology