510(k) · Cleared
ClearedMobis II
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 Jul 2, 2013 as substantially equivalent to K111792 (Signus Medizintechnik GmbH, 2012) and 1 other predicate after a 50-day review. Its family tree reaches back 8 generations to 1984. 462 later devices descend from it.
- Decided
- Jul 2, 2013
- Review
- 50 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K841189 (1984). 45 ancestors in all. 462 later devices descend from it, 1 citing it directly.
- Root · 8 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 7 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 6 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 5 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 4 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 3 generations backK033109 Ellys and Aurys Vertebral Body ReplacementsScient'X · 2004
- 2 generations backK043479 MC+ Partial VBRLdr Spine USA · 2005
- 1 generation backK090064 Eminent Spine Interbody Fusion SystemEminent Spine · 2009 · Recalled
- This deviceK131372 Mobis IISignus Medizintechnik GmbH · 2013
- Descendant · cites it directly · 461 of its ownK141405 Mobis II ST Spinal ImplantSignus Medizintechnik GmbH · 2014
- Descendant · 2 generations on · 459 of its ownK150481 Cascadia Interbody SystemK2m, Inc. · 2015 · Recalled
- Descendant · 3 generations on · 315 of its ownK160125 Cascadia Interbody SystemK2m · 2016
- Descendant · 3 generations on · 276 of its ownK163230 NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated · 2017
- Descendant · 4 generations on · 227 of its ownK172123 NuVasive® Modulus XLIF Interbody SystemNu Vasive, Incorporated · 2017
Showing 5 of 462 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 462 · See all- K141405Mobis II ST Spinal ImplantSignus Medizintechnik GmbH · 2014 · cites it directly461descendants
- K150481Cascadia Interbody SystemK2m, Inc. · 2015 · 2 generations on459descendants
- K160125Cascadia Interbody SystemK2m · 2016 · 3 generations on315descendants
- K163230NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated · 2017 · 3 generations on276descendants
- K172123NuVasive® Modulus XLIF Interbody SystemNu Vasive, Incorporated · 2017 · 4 generations on227descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −7 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −6 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −5 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −4 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −3 | K033109 | Ellys and Aurys Vertebral Body Replacements | Scient'X | 2004 | — |
| −2 | K043479 | MC+ Partial VBR | Ldr Spine USA | 2005 | — |
| −1 | K090064 | Eminent Spine Interbody Fusion System | Eminent Spine | 2009 | 1 |
| 0 (this device) | K131372 | Mobis II | Signus Medizintechnik GmbH | 2013 | — |
| +1 | K141405 | Mobis II ST Spinal Implant | Signus Medizintechnik GmbH | 2014 | — |
| +2 | K150481 | Cascadia Interbody System | K2m, Inc. | 2015 | 3 |
| +3 | K160125 | Cascadia Interbody System | K2m | 2016 | — |
| +3 | K163230 | NuVasive Modulus XLIF Interbody System | Nu Vasive, Incorporated | 2017 | — |
| +4 | K172123 | 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 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 8 | 0 |
| 2002 | 5 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2007 | 4 | 0 |
| 2008 | 7 | 0 |
| 2009 | 2 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 5 | 0 |
| 2017 | 19 | 0 |
| 2018 | 22 | 0 |
| 2019 | 31 | 0 |
| 2020 | 48 | 0 |
| 2021 | 43 | 0 |
| 2022 | 50 | 0 |
| 2023 | 67 | 0 |
| 2024 | 73 | 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? (3)
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 |
|---|---|---|---|
| * | K111792 | Mobis, Moval, Semial, Tetrismodel Peek and Titanium, Kimba Model Standard and MiniSummary page 1…egral marker pins used in the devices are manufactured from tantalum as described by ASTM F560. Predicate Devices: MOBISO and PEEK TETRIS h (K1 11792) Python (K090064) Performance Data: Mechanical testing of the worst case MOBIS® 11was -performed… | 2012 |
| * | K090064 | Eminent Spine Interbody Fusion SystemSummary page 1…manufactured from tantalum as described by ASTM F560. Predicate Devices: MOBISO and PEEK TETRIS h (K1 11792) Python (K090064) Performance Data: Mechanical testing of the worst case MOBIS® 11was -performed according to ASTM F… | 2009 |
| * | — | Mobiso Named without a submission number |
What descends from it? (462)
See all 4621 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K141405 | Mobis II ST Spinal Implant | 2014 | 461 |
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 29 years and passes through 8 companies; a new generation was cleared every 1.9 years on median.
- 7 of the 45 ancestors have a recall of any class.
- Of its descendants, K141405 (Signus Medizintechnik GmbH, 2014) has gone furthest, with 461 descendants of its own.
- 4 other devices also cite its predicate K111792.
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. 2013, 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 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131372 · printed Nov 5, 2026
Cite this page
510(k) Report. “K131372: Mobis II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K131372
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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