# K122317: Tetris II

- Pathway: 510(k) (Special)
- Applicant: Signus Medizintechnik GmbH
- Decided: Aug 29, 2012 after 28 days
- Product code: MAX (Intervertebral Fusion Device With Bone Graft, Lumbar)
- Device class: 2
- Regulation: 21 CFR 888.3080
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K010530 (2001). 23 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022793: Tetris Spinal Implant, Signus Medical, LLC (2003) Summary page 1.
- K031757: Peek Tetris Spinal Implant, Signus Medical, LLC (2003) Summary page 1.
- K111792: Mobis, Moval, Semial, Tetrismodel Peek and Titanium, Kimba Model Standard and Mini, Signus Medizintechnik GmbH (2012) Summary page 1.

## Most influential descendants
- K241438: Signus Tetris™ St; Signus Tetris™ R St (2024), 0 descendants of its own
- K181899: Roccia® Plif (2018), 0 descendants of its own

## Indications for use
When used as a vertebral body replacement, the TETRI STM 11 devices are 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. When used as an intervertebral fusion device, the TETRIS~m 11devices are intended for use at one level in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDID is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is to be used in patients who have had six months of non-operative treatment. The devices are intended for use with a supplemental internal fixation system and with autograft to facilitate fusion.

Source page: https://510kreport.com/device/K122317
Methodology: https://510kreport.com/methodology