# K031757: Peek Tetris Spinal Implant

- Pathway: 510(k) (Special)
- Applicant: Signus Medical, LLC
- Decided: Jul 30, 2003 after 54 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: 4 generations back to K841189 (1984). 5 ancestors in all.
1,702 later devices descend from it; 13 cite it directly.
1 of 1,708 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022793: Tetris Spinal Implant, Signus Medical, LLC (2003)

## Most influential descendants
- K041888: Curved Peek Tetris Spinal Implant (2004), 1,586 descendants of its own
- 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
- K033109: Ellys and Aurys Vertebral Body Replacements (2004), 1,218 descendants of its own

## Indications for use
The PEEK TetrisTM 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 T1 to L5). The PEEK TetrisTM Spinal Implant is intended for use with Supplemental internal fixation. The supplemental internal fixation systems that may be used with ithe PEEK TetrisTM Spinal Implant include, but are not limited to, DePuy AcroMed titanium plate or rod systems (Kaneda SR, University Plate, M2, ISOLA, VSP, MOSS, T i m, and Profile).

Source page: https://510kreport.com/device/K031757
Methodology: https://510kreport.com/methodology