# K241438: Signus Tetris™ St; Signus Tetris™ R St

- Pathway: 510(k) (Traditional)
- Applicant: Signus Medizintechnik GmbH
- Decided: Sep 11, 2024 after 113 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: 13 generations back to K841189 (1984). 81 ancestors in all.
No later device cites it as a predicate yet.
0 of 82 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122317: Tetris II, Signus Medizintechnik GmbH (2012) Summary page 5.
- K123758: Tasmin R, Signus Medizintechnik GmbH (2014) Summary page 5.
- K141405: Mobis II ST Spinal Implant, Signus Medizintechnik GmbH (2014) Summary page 5.

## Indications for use
When used as an intervertebral fusion device, the TETRIS™ ST devices 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. DDD 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 autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.

Source page: https://510kreport.com/device/K241438
Methodology: https://510kreport.com/methodology