510(k) · Cleared
ClearedObelisc Vertebral Body Replacement Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ulrich GmbH & Co. KG · MQP Spinal Vertebral Body Replacement Device
Cleared on Dec 26, 2006 as substantially equivalent to K050850 (Globus Medical, Inc., 2005) and 1 other predicate after a 312-day review. Its family tree reaches back 5 generations to 2001. 56 later devices descend from it.
- Decided
- Dec 26, 2006
- Review
- 312 days
- Class
- Class II
- Product code
- MQP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K003275 (2001). 7 ancestors in all, the oldest K003155 (2001). 56 later devices descend from it, 9 citing it directly.
- Root · 5 generations backK003275 Synthes Synmesh Spacer SystemSynthes (Usa) · 2001 · Recalled
- 4 generations backK020152 Synthes Vertebral Spacer TISynthes (Usa) · 2002
- 3 generations backK024364 Synthes Vertebral Spacer TI (Curved and Narrow)Synthes (Usa) · 2003
- 2 generations backK031302 Sustain SpacerGlobus Medical, Inc. · 2003
- 1 generation backK050850 Xpand Corpectomy SpacerGlobus Medical, Inc. · 2005
- This deviceK060416 Obelisc Vertebral Body Replacement DeviceUlrich GmbH & Co. KG · 2006
- Descendant · cites it directly · 49 of its ownK110864 Biospine VBR SystemAesculap Implant Systems, LLC · 2011
- Descendant · cites it directly · 48 of its ownK133802 Ais Modulift VBR SystemAesculap Implant System, Inc. · 2014
- Descendant · cites it directly · 47 of its ownK142150 Ais Modulift VBR SystemAesculap Implant System, Inc. · 2014
- Descendant · 2 generations on · 46 of its ownK172032 Modulift Vertebral Body Replacement (VBR) SystemAesculap Implants Systems, Inc. · 2017
- Descendant · 3 generations on · 28 of its ownK181328 T2 STRATOSPHERE™ Expandable Corpectomy SystemMedtronic Sofamor Danek USA, Inc. · 2018
Showing 5 of 56 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 56 · See all- K110864Biospine VBR SystemAesculap Implant Systems, LLC · 2011 · cites it directly49descendants
- K133802Ais Modulift VBR SystemAesculap Implant System, Inc. · 2014 · cites it directly48descendants
- K142150Ais Modulift VBR SystemAesculap Implant System, Inc. · 2014 · cites it directly47descendants
- K172032Modulift Vertebral Body Replacement (VBR) SystemAesculap Implants Systems, Inc. · 2017 · 2 generations on46descendants
- K181328T2 STRATOSPHERE™ Expandable Corpectomy SystemMedtronic Sofamor Danek USA, Inc. · 2018 · 3 generations on28descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K003275 | Synthes Synmesh Spacer System | Synthes (Usa) | 2001 | 14 |
| −4 | K020152 | Synthes Vertebral Spacer TI | Synthes (Usa) | 2002 | — |
| −3 | K024364 | Synthes Vertebral Spacer TI (Curved and Narrow) | Synthes (Usa) | 2003 | — |
| −2 | K031302 | Sustain Spacer | Globus Medical, Inc. | 2003 | — |
| −1 | K050850 | Xpand Corpectomy Spacer | Globus Medical, Inc. | 2005 | — |
| 0 (this device) | K060416 | Obelisc Vertebral Body Replacement Device | Ulrich GmbH & Co. KG | 2006 | — |
| +1 | K110864 | Biospine VBR System | Aesculap Implant Systems, LLC | 2011 | — |
| +1 | K133802 | Ais Modulift VBR System | Aesculap Implant System, Inc. | 2014 | — |
| +1 | K142150 | Ais Modulift VBR System | Aesculap Implant System, Inc. | 2014 | — |
| +2 | K172032 | Modulift Vertebral Body Replacement (VBR) System | Aesculap Implants Systems, Inc. | 2017 | — |
| +3 | K181328 | T2 STRATOSPHERE™ Expandable Corpectomy System | Medtronic Sofamor Danek USA, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 3 | 0 |
| 2017 | 3 | 0 |
| 2018 | 3 | 0 |
| 2019 | 6 | 0 |
| 2020 | 4 | 0 |
| 2022 | 3 | 0 |
| 2023 | 6 | 0 |
| 2024 | 9 | 0 |
| 2025 | 6 | 0 |
| 2026 | 11 | 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? (2)
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 |
|---|---|---|---|
| * | K050850 | Xpand Corpectomy SpacerSummary page 1…This device is substantially equivalent to the following legally marketed devices: 510(k) Reference Description Submifted By K050850 XPAND Corpectomy Globus Medical, Inc. ___ ___ ___ ___… | 2005 |
| * | K012254 | VBRSummary page 1…ectomy Globus Medical, Inc. ___ ___ ___ ___ ___ ___ _ -Spacer _ _ _ _ _ _ _ _ _ _ _ _ K012254 VBRTm Vertebral Body Osteotech, Inc. ___________________ -R… | 2001 |
What descends from it? (56)
See all 569 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K110864 | Biospine VBR System | 2011 | 49 |
| K133802 | Ais Modulift VBR System | 2014 | 48 |
| K142150 | Ais Modulift VBR System | 2014 | 47 |
| K142016 | CAPRI | 2014 | 12 |
| K180673 | Normandy VBR System | 2018 | 7 |
| K183071 | VLIFT-s Vertebral Body Replacement System | 2019 | 4 |
| K191423 | Normandy VBR System | 2019 | 3 |
| K112429 | Giza (R) Vertebral Body Replacement | 2012 | 2 |
| K200235 | KONG-TL VBR System, KONG-C VBR System | 2020 | 1 |
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 5 years and passes through 3 companies; a new generation was cleared every 12 months on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K110864 (Aesculap Implant Systems, LLC, 2011) has gone furthest, with 49 descendants of its own.
- 4 other devices also cite its predicate K050850.
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?
Vertebral body replacement intended for use during open surgical procedures in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (e.g., fracture). The obeliscTM Vertebral Body Replacement is intended to be used with supplemental internal spinal fixation systems that have been labeled for use in the thoracic and lumbar spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). The use of bone grafting material with the obeliscTM Vertebral Body Replacement is optional.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060416 · printed Nov 4, 2026
Cite this page
510(k) Report. “K060416: Obelisc Vertebral Body Replacement Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060416
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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