# K111792: Mobis, Moval, Semial, Tetrismodel Peek and Titanium, Kimba Model Standard and Mini

- Pathway: 510(k) (Traditional)
- Applicant: Signus Medizintechnik GmbH
- Decided: Mar 5, 2012 after 252 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: 6 generations back to K010530 (2001). 16 ancestors in all.
470 later devices descend from it; 5 cite it directly.
0 of 487 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P960025: Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle Screws, Depuy Spine, Inc. (1999) Summary page 2.
- P950019: Ray Threaded Fusion Cage (TFC)(TM) with Instrumentation, Stryker Spine (1996) Summary page 2.
- K073470: Avs PL Peek Spacers, Models 48351XXX and 48353XXX, Stryker Spine (2008) Summary page 2.
- K082014: Stryker Spine Avs PL Peek Spacers, Stryker Corp. (2008) Summary page 2.
- K083661: Avs TL Peek Spacers, Stryker Corp. (2009) Summary page 2.
- K090166: Avs Anterior Large Peek Spacers, Stryker Corp. (2009) Summary page 2.
- K073669: Oria Natura Spacer, Choicespine, LP (2008) Summary page 2.

## Most influential descendants
- K131372: Mobis II (2013), 462 descendants of its own
- 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

## Indications for use
When used as a vertebral body replacement, the MOBIS®, SEMVIAL®, and PEEK and Titanium TETRISTh devices are indicated for use to replace a vertebral body that has been resected or excised due to tumor or traurria/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 a vertebral body replacement, the KIMVBA® and KIMBA® mini devices are indicated for use to replace a vertebral body that has been resected or excised due to tumor or trauma/fracture. The devices are intended for use as a vertebral body replacement in the lumbar spine (from Li to L5) and are intended for use with supplemental internal fixation. When used as an intervertebral fusion device in skeletally mature patients, the KIMBA®, KIMBA® mini, MOBIS®, NOVAL®, SEMIAL®, and PEEK and Titanium TETRISTh 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. ODD 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 non-fusion 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/K111792
Methodology: https://510kreport.com/methodology