# K141405: Mobis II ST Spinal Implant

- Pathway: 510(k) (Traditional)
- Applicant: Signus Medizintechnik GmbH
- Decided: Sep 16, 2014 after 111 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: 9 generations back to K841189 (1984). 50 ancestors in all.
461 later devices descend from it; 2 cite it directly.
0 of 512 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131372: Mobis II, Signus Medizintechnik GmbH (2013) Summary page 5.
- K100089: Synthes T-Pal Spacer, Synthes Spine (2010) Summary page 5.
- K071724: Lucent, Spinal Elements, Inc. (2007) Summary page 5.
- K081968: Modification to Lucent, Spinal Elements, Inc. (2008) Summary page 5.

## Most influential descendants
- 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
- K162264: Cascadia Interbody System (2016), 169 descendants of its own

## Indications for use
The MOBIS®II ST Spinal Implant is indicated for intervertebral body spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). MOBIS®II ST Spinal Implants are to be used with autogenous bone graft and implanted via an open posterior or transforaminal approach. The MOBIS®II ST Spinal Implant is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

Source page: https://510kreport.com/device/K141405
Methodology: https://510kreport.com/methodology