# K043479: MC+ Partial VBR

- Pathway: 510(k) (Traditional)
- Applicant: Ldr Spine USA
- Decided: Jun 30, 2005 after 196 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). 22 ancestors in all.
1,214 later devices descend from it; 18 cite it directly.
1 of 1,237 devices in its family (counting itself) has 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.
- K043206: Pioneer Vertebral Body Replacement Device (Pioneer Vertebral Spacer), Pioneer Surgical Technology (2005). Cleared while this submission was under review Summary page 1.
- K032064: Theken Cpod/Lpod Vertebral Body Replacement System, Theken Surgical,Llc (2004) Summary page 1.
- K033109: Ellys and Aurys Vertebral Body Replacements, Scient'X (2004) Summary page 1.

## Most influential descendants
- K080728: LDR Spine Roi-C Implant (2008), 903 descendants of its own
- 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
- K100042: Difusion Technologies Xiphos Interbody Fusion System (2010), 864 descendants of its own
- K111512: Bonebac T-Plif Intervertebral Body Fusion Device System (2011), 762 descendants of its own

## Indications for use
The MC+ is indicated for use for partial replacement (i.e.: partial vertebrectomy) of a diseased vertebral body that has been resected or excised due to tumor or trauma/fracture in order to achieve anterior decompression of the spinal chord and neural tissues, and to restore the height of a collapsed vertebral body. The components are intended for use in pairs for use as a partial vertebral body replacement in the thoracolumbar spine (from TI to L5) and are intended for use with supplemental internal fixation such as the Easyspine System to properly utilize this system.

Source page: https://510kreport.com/device/K043479
Methodology: https://510kreport.com/methodology