510(k) · Cleared
ClearedMobis Spinal Implant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Signus Medizintechnik GmbH · MQP Spinal Vertebral Body Replacement Device
Cleared on Dec 18, 2006 as substantially equivalent to K041888 (Signus Medizintechnik GmbH, 2004) after a 244-day review. Its family tree reaches back 6 generations to 1984.
- Decided
- Dec 18, 2006
- Review
- 244 days
- Class
- Class II
- Product code
- MQP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K841189 (1984). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 5 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 4 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 3 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 2 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 1 generation backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- This deviceK061082 Mobis Spinal ImplantSignus Medizintechnik GmbH · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −5 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −4 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −3 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −2 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −1 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| 0 (this device) | K061082 | Mobis Spinal Implant | Signus Medizintechnik GmbH | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 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 MQP? 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 MQP device
- #1 K261810 Vertiwedge® Intraosseous Systemscore 18.1 · 22 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K041888 | Curved Peek Tetris Spinal ImplantSummary page 1…Name: MOBIS ® Classification 21 CFR 888.3060 Name and Number: Product Code: MQP Predicate Device Curved PEEK TETRISTM cleared under K041888 on 8/10/24. Device Description: The MOBIS ' Spinal implant is the same as the predicate device except… | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
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 22 years and passes through 5 companies; a new generation was cleared every 1.9 years on median.
- None of the 7 ancestors has a recall.
- 10 other devices also cite its predicate K041888.
How does its category compare?
All MQP devicesMQP Spinal Vertebral Body Replacement Device: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MQP
4in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · MQP
187in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MQP
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MQP
168in 2025
MAUDE reports naming product code MQP, 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 | 30 | 107 | 2 | 61 |
| 2008 | 17 | 47 | 0 | 76 |
| 2009 | 11 | 115 | 14 | 111 |
| 2010 | 6 | 174 | 2 | 166 |
| 2011 | 8 | 237 | 1 | 121 |
| 2012 | 7 | 82 | 2 | 141 |
| 2013 | 3 | 90 | 0 | 207 |
| 2014 | 5 | 125 | 0 | 216 |
| 2015 | 8 | 126 | 0 | 258 |
| 2016 | 0 | — | 0 | 129 |
| 2017 | 9 | 97 | 0 | 141 |
| 2018 | 6 | 152 | 0 | 130 |
| 2019 | 8 | 93 | 0 | 117 |
| 2020 | 3 | 103 | 15 | 157 |
| 2021 | 0 | — | 0 | 208 |
| 2022 | 1 | — | 1 | 137 |
| 2023 | 1 | — | 0 | 71 |
| 2024 | 4 | 187 | 0 | 98 |
| 2025 | 0 | — | 0 | 168 |
| 2026 | 3 | 102 | 0 | — |
What is it indicated for?
The MOBIS® Spinal Implant is indicated for use to replace a vertebral body that has been resected or excised due to tumor or trauma/fracture. The device is intended for use as a vertebral body replacement in the thoracolumbar spine (from T1 to L5) and is intended for use with supplemental internal fixation.
The MOBIS® may be implanted singularly or in pairs.
The supplemental internal fixation systems that may be used with the MOBIS® includes, but is not limited to, DePuy AcroMed titanium plate or rod systems (Kaneda SR, University Plate, M2, ISOLA, VSP, Moss, TiMX, and Profile.)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061082 · printed Nov 4, 2026
Cite this page
510(k) Report. “K061082: Mobis Spinal Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061082
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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