# K051659: Semial Spinal Implant

- Pathway: 510(k) (Special)
- Applicant: Signus Medizintechnik GmbH
- Decided: Jul 13, 2005 after 21 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.
790 later devices descend from it; 1 cites it directly.
1 of 798 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
- 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
- K083311: Aesculap Cespace Peek Intervertebral Body Fusion System (2009), 554 descendants of its own
- K100802: Aesculap Implant Systems Sibd Spinal System (2010), 461 descendants of its own
- K111122: Aesculap Sibd XP Spinal System (2011), 460 descendants of its own

## Indications for use
The SEMIALTM 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. The SEMIALTM is intended to be implanted singularly. The internal fixation systems that may be used 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/K051659
Methodology: https://510kreport.com/methodology