# K022793: Tetris Spinal Implant

- Pathway: 510(k) (Traditional)
- Applicant: Signus Medical, LLC
- Decided: Apr 8, 2003 after 228 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: 3 generations back to K841189 (1984). 4 ancestors in all.
1,705 later devices descend from it; 6 cite it directly.
1 of 1,710 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001340: Stackable Cage System, Depuyacromed (2000)
- K990148: Stackable Cage System, Depuy Motech Acromed (1999) Summary page 1.
- K003043: Surgical Titanium Mesh System, Depuyacromed (2001) Summary page 1.

## Most influential descendants
- K031757: Peek Tetris Spinal Implant (2003), 1,702 descendants of its own
- 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

## Indications for use
The TETRIS™ Spinal Implant is indicated for use to replace a vertebral body that has been resected or excised due to tumor or traumdfracture. The device is intended for use as a vertebral body replacement in the thoracolumbar spine (from T1 to L5). The TETRIS™ Spinal Implant is intended for use with supplemental internal fixation. The supplemental internal fixations systems that may be used with the TETRIS™ Spinal Implant include, but are not limited to, DePuy AcroMed titanium plate or rod systems (Kaneda SR, University Plate, M2, KOLA, VSP, Moss, TiMX, and Profile).

Source page: https://510kreport.com/device/K022793
Methodology: https://510kreport.com/methodology