# K131372: Mobis II

- Pathway: 510(k) (Traditional)
- Applicant: Signus Medizintechnik GmbH
- Decided: Jul 2, 2013 after 50 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: 8 generations back to K841189 (1984). 45 ancestors in all.
462 later devices descend from it; 1 cites it directly.
0 of 508 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111792: Mobis, Moval, Semial, Tetrismodel Peek and Titanium, Kimba Model Standard and Mini, Signus Medizintechnik GmbH (2012) Summary page 1.
- K090064: Eminent Spine Interbody Fusion System, Eminent Spine (2009) Summary page 1.
- (no number) Mobiso: named in the summary without a submission number

## Most influential descendants
- K141405: Mobis II ST Spinal Implant (2014), 461 descendants of its own
- K150481: Cascadia Interbody System (2015), 459 descendants of its own
- K160125: Cascadia Interbody System (2016), 315 descendants of its own
- K163230: NuVasive Modulus XLIF Interbody System (2017), 276 descendants of its own
- K172123: NuVasive® Modulus XLIF Interbody System (2017), 227 descendants of its own

## Indications for use
When used as an intervertebral fusion device, the MOBISt 11 devices are intended for use at one or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DOID) with up to Grade I spondylolisthesis. DODD 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. Patients with previous nonfusion spinal surgery at the involved level may be treated with the device. The devices are intended for use with a supplemental internal fixation system and with autograft to facilitate fusion.

Source page: https://510kreport.com/device/K131372
Methodology: https://510kreport.com/methodology