# K041888: Curved Peek Tetris Spinal Implant

- Pathway: 510(k) (Special)
- Applicant: Signus Medizintechnik GmbH
- Decided: Aug 10, 2004 after 29 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: 5 generations back to K841189 (1984). 6 ancestors in all.
1,586 later devices descend from it; 11 cite it directly.
1 of 1,593 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031757: Peek Tetris Spinal Implant, Signus Medical, LLC (2003) Summary page 1.

## Most influential descendants
- K042930: Spacevision Cage System (2004), 1,440 descendants of its own
- K062759: Paramount VBR System (2007), 1,406 descendants of its own
- K072120: Paramount Intervertebral Body Fusion Device (2007), 1,405 descendants of its own
- K073291: Capstone Spinal System (2008), 1,103 descendants of its own
- K100175: Clydesdale Spinal System (2010), 1,008 descendants of its own

## Indications for use
The Curved PEEK Tetris Tm 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 Curved PEEK Tetris ir: may be implanted singularly or in pairs. The supplemental internal fixation systems that may be used with the Curved PEEK TetrisTh Spinal Implant is the same as the Curved PEEK Tetris 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/K041888
Methodology: https://510kreport.com/methodology