510(k) · Cleared
ClearedSolidity Vertebral Body Replacement
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ulrich Medical USA · MQP Spinal Vertebral Body Replacement Device
Cleared on Nov 16, 2018 as substantially equivalent to K012254 (Osteotech, Inc., 2001) and 4 other predicates after a 121-day review. Its family tree reaches back 21 generations to 1984. 1 of the 204 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it.
- Decided
- Nov 16, 2018
- Review
- 121 days
- Class
- Class II
- Product code
- MQP
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 21 generations to K841189 (1984). 201 ancestors in all. 2 later devices descend from it, 1 citing it directly. 1 of the 204 devices in this family, counting this one, has a Class I recall.
- Root · 21 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 17 generations between
- 3 generations backK153495 Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF…Ldr Spine USA · 2016 · Recalled
- 2 generations backK162103 Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™…Choicespine, LP · 2016
- 1 generation backK171686 Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) SystemChoicespine · 2017
- This deviceK181921 Solidity Vertebral Body ReplacementUlrich Medical USA · 2018
- Descendant · cites it directly · 1 of its ownK200235 KONG-TL VBR System, KONG-C VBR SystemIcotec AG · 2020
- Descendant · 2 generations on · 0 of its ownK232790 KONG®-TL VBR System and KONG® C VBR SystemIcotec AG · 2024
Show all 21 generations
- Root · 21 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 20 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 19 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 18 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 17 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 16 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 15 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 14 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 13 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 12 generations backK080083 Intrepid Spinal SystemMedtronic Sofamor Danek · 2008 · Recalled
- 11 generations backK073109 Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008
- 10 generations backK081849 Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc. · 2008 · Recalled
- 9 generations backK091301 Life Spine Stand-Alone Spacer SystemLife Spine · 2009
- 8 generations backK100802 Aesculap Implant Systems Sibd Spinal SystemAesculap Implant Systems, Inc. · 2010
- 7 generations backK111122 Aesculap Sibd XP Spinal SystemAesculap Implant Systems, Inc. · 2011
- 6 generations backK141942 Midline II TICentinel Spine, Inc. · 2014
- 5 generations backK150643 Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-TiCentinel Spine, Inc. · 2015
- 4 generations backK152475 FORZA PTC Spacer SystemOrthofix, Inc. · 2016
- 3 generations backK153495 Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF…Ldr Spine USA · 2016 · Recalled
- 2 generations backK162103 Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™…Choicespine, LP · 2016
- 1 generation backK171686 Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) SystemChoicespine · 2017
- This deviceK181921 Solidity Vertebral Body ReplacementUlrich Medical USA · 2018
Class I recalls in this family
- K073202 Ardis Spacer6 generations back · 2008
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −21 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −20 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −19 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −18 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −17 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −16 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −15 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −14 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −13 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −12 | K080083 | Intrepid Spinal System | Medtronic Sofamor Danek | 2008 | 8 |
| −11 | K073109 | Stalif TT Intervertebral Body Fusion System | Surgicraft, Ltd. | 2008 | — |
| −10 | K081849 | Blackstone Pillar SA Partial Vertebral Body Replacement Device | Blackstone Medical, Inc. | 2008 | 1 |
| −9 | K091301 | Life Spine Stand-Alone Spacer System | Life Spine | 2009 | — |
| −8 | K100802 | Aesculap Implant Systems Sibd Spinal System | Aesculap Implant Systems, Inc. | 2010 | — |
| −7 | K111122 | Aesculap Sibd XP Spinal System | Aesculap Implant Systems, Inc. | 2011 | — |
| −6 | K141942 | Midline II TI | Centinel Spine, Inc. | 2014 | — |
| −5 | K150643 | Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-Ti | Centinel Spine, Inc. | 2015 | — |
| −4 | K152475 | FORZA PTC Spacer System | Orthofix, Inc. | 2016 | — |
| −3 | K153495 | Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage… | Ldr Spine USA | 2016 | 1 |
| −2 | K162103 | Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice… | Choicespine, LP | 2016 | — |
| −1 | K171686 | Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) System | Choicespine | 2017 | — |
| 0 (this device) | K181921 | Solidity Vertebral Body Replacement | Ulrich Medical USA | 2018 | — |
| +1 | K200235 | KONG-TL VBR System, KONG-C VBR System | Icotec AG | 2020 | — |
| +2 | K232790 | KONG®-TL VBR System and KONG® C VBR System | Icotec AG | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 10 | 0 |
| 2002 | 8 | 0 |
| 2003 | 15 | 0 |
| 2004 | 22 | 0 |
| 2005 | 19 | 0 |
| 2006 | 7 | 0 |
| 2007 | 11 | 0 |
| 2008 | 28 | 1 |
| 2009 | 15 | 0 |
| 2010 | 11 | 0 |
| 2011 | 11 | 0 |
| 2012 | 6 | 0 |
| 2013 | 5 | 0 |
| 2014 | 4 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2024 | 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.
1 device in this family has a Class I recall. 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? (5)
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 |
|---|---|---|---|
| * | K012254 | VBRSummary page 4…Solidity™ components are manufactured from Ti-6Al-4V ELI titanium alloy (ASTM F136). Predicate Devices: Primary: VBR™ (Osteotech Inc. – K012254) Additional: VBR™ (Osteotech Inc. – K003155), Hawkeye™ VBR System (Choice Spine… | 2001 |
| * | K003155 | Vertebral Body ReplacementSummary page 4…alloy (ASTM F136). Predicate Devices: Primary: VBR™ (Osteotech Inc. – K012254) Additional: VBR™ (Osteotech Inc. – K003155), Hawkeye™ VBR System (Choice Spine LP – K171686), Surgical Titanium Mesh™ System (DePuy… | 2001 |
| * | K171686 | Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) SystemSummary page 4…ry: VBR™ (Osteotech Inc. – K012254) Additional: VBR™ (Osteotech Inc. – K003155), Hawkeye™ VBR System (Choice Spine LP – K171686), Surgical Titanium Mesh™ System (DePuy AcroMed, K003043), Rezaian Spinal Fixator (Orthopedic Equipment… | 2017 |
| * | K003043 | Surgical Titanium Mesh SystemSummary page 4…eotech Inc. – K003155), Hawkeye™ VBR System (Choice Spine LP – K171686), Surgical Titanium Mesh™ System (DePuy AcroMed, K003043), Rezaian Spinal Fixator (Orthopedic Equipment Co. Inc. – K841189) Performance Data: Mechanical t… | 2001 |
| * | K841189 | Oec/Rezaian Spinal FixatorSummary page 4…1686), Surgical Titanium Mesh™ System (DePuy AcroMed, K003043), Rezaian Spinal Fixator (Orthopedic Equipment Co. Inc. – K841189) Performance Data: Mechanical testing of worst case Solidity™ devices included static and dynamic… | 1984 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K200235 | KONG-TL VBR System, KONG-C VBR System | 2020 | 1 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K073202Ardis SpacerAbbott Spine, Inc. · 2008 · 6 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 34 years and passes through 18 companies; a new generation was cleared every 9 months on median.
- 27 of the 201 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K200235 (Icotec AG, 2020) has gone furthest, with 1 descendant of its own.
- 17 other devices also cite its predicate K012254.
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. 2018, this device’s year, is highlighted.
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 Solidity™ Vertebral Body Replacement is intended for use during open surgical procedures in the thoracic and lumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (e.g., fracture).
The Solidity™ is intended to be used with supplemental spinal fixation. The use of bone grafting material with the Solidity™ is optional.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K181921 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181921: Solidity Vertebral Body Replacement.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181921
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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