510(k) · Cleared
ClearedSmall VBR™
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 Nov 1, 2019 as substantially equivalent to K173982 (Globus Medical, Inc., 2018) and 2 other predicates after an 87-day review. Its family tree reaches back 15 generations to 1984. 6 later devices descend from it.
- Decided
- Nov 1, 2019
- Review
- 87 days
- Class
- Class II
- Product code
- MQP
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 15 generations to K841189 (1984). 63 ancestors in all. 6 later devices descend from it, 3 citing it directly.
- Root · 15 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 11 generations between
- 3 generations backK152568 C-VBRCardinal Spine, LLC · 2016
- 2 generations backK162315 FORTIFY Corpectomy SpacersGlobus Medical, Inc. · 2017
- 1 generation backK173982 FORTIFY Corpectomy SpacersGlobus Medical, Inc. · 2018
- This deviceK192117 Small VBR™Ulrich GmbH & Co. KG · 2019
- Descendant · cites it directly · 2 of its ownK211892 ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages)Arftx Medical, LLC · 2022
- Descendant · 2 generations on · 1 of its ownK252686 EffortMed PEEK Cages & Corpectomy CagesEffortmed, LLC · 2025
- Descendant · cites it directly · 1 of its ownK200235 KONG-TL VBR System, KONG-C VBR SystemIcotec AG · 2020
- Descendant · 3 generations on · 0 of its ownK260850 Osteomni Spinal Cages SystemOsteomni, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK232790 KONG®-TL VBR System and KONG® C VBR SystemIcotec AG · 2024
Show all 15 generations
- Root · 15 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 14 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 13 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 12 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 11 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 10 generations backK033109 Ellys and Aurys Vertebral Body ReplacementsScient'X · 2004
- 9 generations backK043479 MC+ Partial VBRLdr Spine USA · 2005
- 8 generations backK080728 LDR Spine Roi-C ImplantLdr Spine USA · 2008
- 7 generations backK083857 LDR Spine Roi-C ImplantLdr Spine USA · 2009
- 6 generations backK091088 LDR Spine Cervical Interbody Fusion SystemLdr Spine USA · 2009
- 5 generations backK121176 STGCCardinal Spine, LLC · 2012
- 4 generations backK142030 STGC-LordoticCardinal Spine, LLC · 2015
- 3 generations backK152568 C-VBRCardinal Spine, LLC · 2016
- 2 generations backK162315 FORTIFY Corpectomy SpacersGlobus Medical, Inc. · 2017
- 1 generation backK173982 FORTIFY Corpectomy SpacersGlobus Medical, Inc. · 2018
- This deviceK192117 Small VBR™Ulrich GmbH & Co. KG · 2019
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K211892ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages)Arftx Medical, LLC · 2022 · cites it directly2descendants
- K252686EffortMed PEEK Cages & Corpectomy CagesEffortmed, LLC · 2025 · 2 generations on1descendant
- K200235KONG-TL VBR System, KONG-C VBR SystemIcotec AG · 2020 · cites it directly1descendant
- K260850Osteomni Spinal Cages SystemOsteomni, Inc. · 2026 · 3 generations on0descendants
- K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AG · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −14 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −13 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −12 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −11 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −10 | K033109 | Ellys and Aurys Vertebral Body Replacements | Scient'X | 2004 | — |
| −9 | K043479 | MC+ Partial VBR | Ldr Spine USA | 2005 | — |
| −8 | K080728 | LDR Spine Roi-C Implant | Ldr Spine USA | 2008 | — |
| −7 | K083857 | LDR Spine Roi-C Implant | Ldr Spine USA | 2009 | — |
| −6 | K091088 | LDR Spine Cervical Interbody Fusion System | Ldr Spine USA | 2009 | — |
| −5 | K121176 | STGC | Cardinal Spine, LLC | 2012 | — |
| −4 | K142030 | STGC-Lordotic | Cardinal Spine, LLC | 2015 | — |
| −3 | K152568 | C-VBR | Cardinal Spine, LLC | 2016 | — |
| −2 | K162315 | FORTIFY Corpectomy Spacers | Globus Medical, Inc. | 2017 | — |
| −1 | K173982 | FORTIFY Corpectomy Spacers | Globus Medical, Inc. | 2018 | — |
| 0 (this device) | K192117 | Small VBR™ | Ulrich GmbH & Co. KG | 2019 | — |
| +1 | K211892 | ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages) | Arftx Medical, LLC | 2022 | — |
| +2 | K252686 | EffortMed PEEK Cages & Corpectomy Cages | Effortmed, LLC | 2025 | — |
| +1 | K200235 | KONG-TL VBR System, KONG-C VBR System | Icotec AG | 2020 | — |
| +3 | K260850 | Osteomni Spinal Cages System | Osteomni, Inc. | 2026 | — |
| +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 |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 9 | 0 |
| 2002 | 7 | 0 |
| 2003 | 8 | 0 |
| 2004 | 8 | 0 |
| 2005 | 4 | 0 |
| 2006 | 4 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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? (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 |
|---|---|---|---|
| * | K173982 | FORTIFY Corpectomy SpacersSummary page 5…. K192117 - Page 2 of 2 Primary Predicate: Fortify® (Globus Medical Inc. – K173982) Additional Predicates: VBR™ (Osteotech Inc. – K012254), Rezaian Spinal Fixator (Orthopedic Equipment… | 2018 |
| * | K012254 | VBRSummary page 5…K192117 - Page 2 of 2 Primary Predicate: Fortify® (Globus Medical Inc. – K173982) Additional Predicates: VBR™ (Osteotech Inc. – K012254), Rezaian Spinal Fixator (Orthopedic Equipment Co. Inc. – K841189) Performance Data: Mechanical t… | 2001 |
| * | K841189 | Oec/Rezaian Spinal FixatorSummary page 5…Globus Medical Inc. – K173982) Additional Predicates: VBR™ (Osteotech Inc. – K012254), Rezaian Spinal Fixator (Orthopedic Equipment Co. Inc. – K841189) Performance Data: Mechanical testing of the worst case Small VBR™ devices included static and dy… | 1984 |
What descends from it? (6)
3 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 35 years and passes through 9 companies; a new generation was cleared every 1.3 years on median.
- 6 of the 63 ancestors have a recall of any class.
- Of its descendants, K211892 (Arftx Medical, LLC, 2022) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K173982.
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. 2019, 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 Small VBR is intended for use in skeletally mature patients in the cervical spine (C2-T1) and in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor, osteomyelitis, trauma (i.e. fracture), or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in degenerative disorders. The Small VBR is also intended to restore the integrity of the spinal…
Read the full statement (151 words)
The Small VBR is intended for use in skeletally mature patients in the cervical spine (C2-T1) and in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor, osteomyelitis, trauma (i.e. fracture), or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in degenerative disorders.
The Small VBR is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical, thoracic, and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon’s discretion.
The Small VBR is intended to be used with supplemental spinal fixation systems cleared for use in the cervical, thoracic, and/or lumbar spine. The use of bone grafting material with the Small VBR is optional.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192117 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192117: Small VBR™.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192117
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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