510(k) · Cleared
ClearedMobis, Moval, Semial, Tetrismodel Peek and Titanium, Kimba Model Standard and Mini
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Signus Medizintechnik GmbH · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Mar 5, 2012 as substantially equivalent to P960025 (Depuy Spine, Inc., 1999) and 6 other predicates after a 252-day review. Its family tree reaches back 6 generations to 2001. 470 later devices descend from it.
- Decided
- Mar 5, 2012
- Review
- 252 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 6 generations to K010530 (2001). 16 ancestors in all, the oldest P950002 (1996). 470 later devices descend from it, 5 citing it directly.
- Root · 6 generations backK010530 Geo StructureInterpore Cross Intl. · 2001
- 5 generations backK062083 Synfix -LRSynthes Spine Co.Lp · 2007
- 4 generations backK072253 Synfix-LR SpacerSynthes Spine Co.Lp · 2007 · Recalled
- 3 generations backK073470 Avs PL Peek Spacers, Models 48351XXX and 48353XXXStryker Spine · 2008
- 2 generations backK080758 Avs PL Peek Spacers, Models 48351 and 48353Stryker Corp. · 2008
- 1 generation backK082014 Stryker Spine Avs PL Peek SpacersStryker Corp. · 2008
- This deviceK111792 Mobis, Moval, Semial, Tetrismodel Peek and Titanium, Kimba Model…Signus Medizintechnik GmbH · 2012
- Descendant · cites it directly · 462 of its ownK131372 Mobis IISignus Medizintechnik GmbH · 2013
- Descendant · 2 generations on · 461 of its ownK141405 Mobis II ST Spinal ImplantSignus Medizintechnik GmbH · 2014
- Descendant · 3 generations on · 459 of its ownK150481 Cascadia Interbody SystemK2m, Inc. · 2015 · Recalled
- Descendant · 4 generations on · 315 of its ownK160125 Cascadia Interbody SystemK2m · 2016
- Descendant · 4 generations on · 276 of its ownK163230 NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated · 2017
Showing 5 of 470 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 470 · See all- K131372Mobis IISignus Medizintechnik GmbH · 2013 · cites it directly462descendants
- K141405Mobis II ST Spinal ImplantSignus Medizintechnik GmbH · 2014 · 2 generations on461descendants
- K150481Cascadia Interbody SystemK2m, Inc. · 2015 · 3 generations on459descendants
- K160125Cascadia Interbody SystemK2m · 2016 · 4 generations on315descendants
- K163230NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated · 2017 · 4 generations on276descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K010530 | Geo Structure | Interpore Cross Intl. | 2001 | — |
| −5 | K062083 | Synfix -LR | Synthes Spine Co.Lp | 2007 | — |
| −4 | K072253 | Synfix-LR Spacer | Synthes Spine Co.Lp | 2007 | 1 |
| −3 | K073470 | Avs PL Peek Spacers, Models 48351XXX and 48353XXX | Stryker Spine | 2008 | — |
| −2 | K080758 | Avs PL Peek Spacers, Models 48351 and 48353 | Stryker Corp. | 2008 | — |
| −1 | K082014 | Stryker Spine Avs PL Peek Spacers | Stryker Corp. | 2008 | — |
| 0 (this device) | K111792 | Mobis, Moval, Semial, Tetrismodel Peek and Titanium, Kimba Model Standard and… | Signus Medizintechnik GmbH | 2012 | — |
| +1 | K131372 | Mobis II | Signus Medizintechnik GmbH | 2013 | — |
| +2 | K141405 | Mobis II ST Spinal Implant | Signus Medizintechnik GmbH | 2014 | — |
| +3 | K150481 | Cascadia Interbody System | K2m, Inc. | 2015 | 3 |
| +4 | K160125 | Cascadia Interbody System | K2m | 2016 | — |
| +4 | K163230 | NuVasive Modulus XLIF Interbody System | Nu Vasive, Incorporated | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 5 | 0 |
| 2017 | 19 | 0 |
| 2018 | 24 | 0 |
| 2019 | 31 | 0 |
| 2020 | 50 | 0 |
| 2021 | 43 | 0 |
| 2022 | 50 | 0 |
| 2023 | 67 | 0 |
| 2024 | 74 | 0 |
| 2025 | 54 | 0 |
| 2026 | 48 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MAX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MAX device
- #1 K203714 NuVasive Thoracolumbar Interbody Systems…score 102.5 · 24 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (7)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | P960025 | Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle ScrewsSummary page 2…ibed by ASTM F136 / ISO 5832-3. The KIMBA and KIMBA® mini devices are manufactured from ENDOLIGN® (lnvibio®). Predicate Devices: Lumbar I/P Cage® (P960025) Ray TFCTM Device (P950019) AVS PEEK Spacers (K073470, K082014, K083661 and K090166)… | 1999 |
| * | P950019 | Ray Threaded Fusion Cage (TFC)(TM) with InstrumentationSummary page 2…KIMBA® mini devices are manufactured from ENDOLIGN® (lnvibio®). Predicate Devices: Lumbar I/P Cage® (P960025) Ray TFCTM Device (P950019) AVS PEEK Spacers (K073470, K082014, K083661 and K090166) ORIA Natura (K073669) Technol… | 1996 |
| * | K073470 | Avs PL Peek Spacers, Models 48351XXX and 48353XXXSummary page 2…actured from ENDOLIGN® (lnvibio®). Predicate Devices: Lumbar I/P Cage® (P960025) Ray TFCTM Device (P950019) AVS PEEK Spacers (K073470, K082014, K083661 and K090166) ORIA Natura (K073669) Technological The KIMBA®, KIMBA® mini, MOBIS®, N… | 2008 |
| * | K082014 | Stryker Spine Avs PL Peek SpacersSummary page 2…rom ENDOLIGN® (lnvibio®). Predicate Devices: Lumbar I/P Cage® (P960025) Ray TFCTM Device (P950019) AVS PEEK Spacers (K073470, K082014, K083661 and K090166) ORIA Natura (K073669) Technological The KIMBA®, KIMBA® mini, MOBIS®, NOVAL®, SE… | 2008 |
| * | K083661 | Avs TL Peek SpacersSummary page 2…IGN® (lnvibio®). Predicate Devices: Lumbar I/P Cage® (P960025) Ray TFCTM Device (P950019) AVS PEEK Spacers (K073470, K082014, K083661 and K090166) ORIA Natura (K073669) Technological The KIMBA®, KIMBA® mini, MOBIS®, NOVAL®, SEMIAIL®, P… | 2009 |
| * | K090166 | Avs Anterior Large Peek SpacersSummary page 2…o®). Predicate Devices: Lumbar I/P Cage® (P960025) Ray TFCTM Device (P950019) AVS PEEK Spacers (K073470, K082014, K083661 and K090166) ORIA Natura (K073669) Technological The KIMBA®, KIMBA® mini, MOBIS®, NOVAL®, SEMIAIL®, PEEK Characte… | 2009 |
| * | K073669 | Oria Natura SpacerSummary page 2…(P960025) Ray TFCTM Device (P950019) AVS PEEK Spacers (K073470, K082014, K083661 and K090166) ORIA Natura (K073669) Technological The KIMBA®, KIMBA® mini, MOBIS®, NOVAL®, SEMIAIL®, PEEK Characteristics: TETRISTM and Titanium TETRISTM… | 2008 |
What descends from it? (470)
See all 4705 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 5 companies; a new generation was cleared every 6 months on median.
- 2 of the 16 ancestors have a recall of any class.
- Of its descendants, K131372 (Signus Medizintechnik GmbH, 2013) has gone furthest, with 462 descendants of its own.
- 98 other devices also cite its predicate P960025.
How does its category compare?
All MAX devicesMAX Intervertebral Fusion Device With Bone Graft, Lumbar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · MAX
29in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MAX
85in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MAX
5in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · MAX
811in 2025
MAUDE reports naming product code MAX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 7 | 86 | 0 | 12 |
| 2008 | 35 | 88 | 2 | 19 |
| 2009 | 31 | 102 | 9 | 90 |
| 2010 | 29 | 137 | 0 | 154 |
| 2011 | 49 | 98 | 3 | 201 |
| 2012 | 48 | 69 | 11 (1) | 327 |
| 2013 | 58 | 102 | 0 | 380 |
| 2014 | 58 | 115 | 3 | 366 |
| 2015 | 53 | 113 | 1 | 524 |
| 2016 | 64 | 124 | 6 | 647 |
| 2017 | 76 | 116 | 1 | 596 |
| 2018 | 64 | 114 | 4 | 616 |
| 2019 | 60 | 131 | 1 | 699 |
| 2020 | 56 | 106 | 0 | 640 |
| 2021 | 53 | 109 | 0 | 622 |
| 2022 | 41 | 95 | 1 | 618 |
| 2023 | 30 | 87 | 0 | 576 |
| 2024 | 38 | 91 | 1 | 729 |
| 2025 | 29 | 85 | 5 | 811 |
| 2026 | 18 | 95 | 0 | — |
What is it indicated for?
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®…
Read the full statement (249 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111792 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111792: Mobis, Moval, Semial, Tetrismodel Peek and Titanium, Kimba Model Standard and Mini.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111792
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026