# K043316: Rabea Spinal Implant

- Pathway: 510(k) (Traditional)
- Applicant: Signus Medizintechnik GmbH
- Decided: Feb 7, 2005 after 67 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). 7 ancestors in all.
1,005 later devices descend from it; 5 cite it directly.
1 of 1,013 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041888: Curved Peek Tetris Spinal Implant, Signus Medizintechnik GmbH (2004) Summary page 1.

## Most influential descendants
- K051246: Construx Mini Peek VBR System (2005), 834 descendants of its own
- K052096: Nubic Spinal Implant (2005), 790 descendants of its own
- K060762: Aesculap Peek Vertebral Body Replacement System (2006), 789 descendants of its own
- K071983: Aesculap  Peek Intervertebral Body Fusion System: a Space, Cespace, Prospace, T-Space (2008), 788 descendants of its own
- K060350: Construx PL/TL Peek Partial VBR System (2006), 754 descendants of its own

## Indications for use
The RABEATM Spinal 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 vertebral body replacement in the thoracolumbar spine (from Ti to L5) and is intended for use with supplemental internal fixation. This device is intended to be implanted in pairs. The supplemental internal fixation systems that may be used with the RABEATM Spinal Implant are the same as the Curved PEEK TetrisTM Spinal Implant and include, but are not limited to, DePuy AcroMed titanium plate or rod systems (Kaneda SR, University Plate, M2, ISOLA, VSP, Moss, TiMX, and Profile).

Source page: https://510kreport.com/device/K043316
Methodology: https://510kreport.com/methodology