510(k) · Cleared
ClearedCarboClear VBR System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
CarboFix Orthopedics, Ltd. · MQP Spinal Vertebral Body Replacement Device
Cleared on Oct 11, 2019 as substantially equivalent to K112429 (Eden Spine, LLC, 2012) and 4 other predicates after a 57-day review. Its family tree reaches back 20 generations to 1984. 1 later device descends from it.
- Decided
- Oct 11, 2019
- Review
- 57 days
- Class
- Class II
- Product code
- MQP
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 20 generations to K841189 (1984). 207 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 20 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 16 generations between
- 3 generations backK151773 CONCORDE Bullet Lumbar Interbody SystemMedos International SARL · 2015
- 2 generations backK162327 COUGAR® LS Lateral Cage System and COUGAR® SystemMedos International SARL · 2016
- 1 generation backK173787 X-MESH® Expandable Cage System, OCELOT® Stackable Cage System…Medos International SARL · 2018
- This deviceK192214 CarboClear VBR SystemCarboFix Orthopedics, Ltd. · 2019
- Descendant · cites it directly · 0 of its ownK222874 CarboClear Cervical Cage System, CarboClear Cervical VBR SystemCarbofix Orthpedics, Ltd. · 2023
Show all 20 generations
- Root · 20 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 19 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 18 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 17 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 16 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 15 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 14 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 13 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 12 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 11 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 10 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 9 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 8 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 7 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 6 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 5 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 4 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 3 generations backK151773 CONCORDE Bullet Lumbar Interbody SystemMedos International SARL · 2015
- 2 generations backK162327 COUGAR® LS Lateral Cage System and COUGAR® SystemMedos International SARL · 2016
- 1 generation backK173787 X-MESH® Expandable Cage System, OCELOT® Stackable Cage System…Medos International SARL · 2018
- This deviceK192214 CarboClear VBR SystemCarboFix Orthopedics, Ltd. · 2019
Most influential descendants
Showing 1 of 1 · See all- K222874CarboClear Cervical Cage System, CarboClear Cervical VBR SystemCarbofix Orthpedics, Ltd. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −20 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −19 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −18 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −17 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −16 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −15 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −14 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −13 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −12 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −11 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −10 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −9 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −8 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −7 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −6 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −5 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −4 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −3 | K151773 | CONCORDE Bullet Lumbar Interbody System | Medos International SARL | 2015 | — |
| −2 | K162327 | COUGAR® LS Lateral Cage System and COUGAR® System | Medos International SARL | 2016 | — |
| −1 | K173787 | X-MESH® Expandable Cage System, OCELOT® Stackable Cage System, Stackable Cage… | Medos International SARL | 2018 | — |
| 0 (this device) | K192214 | CarboClear VBR System | CarboFix Orthopedics, Ltd. | 2019 | — |
| +1 | K222874 | CarboClear Cervical Cage System, CarboClear Cervical VBR System | Carbofix Orthpedics, Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1996 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 10 | 0 |
| 2002 | 8 | 0 |
| 2003 | 14 | 0 |
| 2004 | 17 | 0 |
| 2005 | 11 | 0 |
| 2006 | 7 | 0 |
| 2007 | 12 | 0 |
| 2008 | 30 | 0 |
| 2009 | 18 | 0 |
| 2010 | 13 | 0 |
| 2011 | 13 | 0 |
| 2012 | 10 | 0 |
| 2013 | 8 | 0 |
| 2014 | 7 | 0 |
| 2015 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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? (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 |
|---|---|---|---|
| * | K112429 | Giza (R) Vertebral Body ReplacementSummary page 5…K192214 - Page 2 of 3 CarboFix Orthopedics, Ltd. CarboClear® VBR System Predicate Devices Primary Giza® Vertebral Body Replacement (Eden Spine, LLC; K112429, and more) Additional X-MESH™ Cage System (DePuy Spine; K173787, and more) Ocelot Stackable Cage System (DePuy Spine;… | 2012 |
| * | K173787 | X-MESH® Expandable Cage System, OCELOT® Stackable Cage System, Stackable Cage System…Summary page 5…ear® VBR System Predicate Devices Primary Giza® Vertebral Body Replacement (Eden Spine, LLC; K112429, and more) Additional X-MESH™ Cage System (DePuy Spine; K173787, and more) Ocelot Stackable Cage System (DePuy Spine; K140759, and more) Bengal Cage System (DePuy Synthes Spine; K07… | 2018 |
| * | K140759 | Bengal System, Bengal Stackable System, Concorde Bullet Lumbar, Concorde Inline Lumbar…Summary page 5…y Replacement (Eden Spine, LLC; K112429, and more) Additional X-MESH™ Cage System (DePuy Spine; K173787, and more) Ocelot Stackable Cage System (DePuy Spine; K140759, and more) Bengal Cage System (DePuy Synthes Spine; K073649, and more) VERTE-STACK™ (Medtronic Sofamor Danek; K070173… | 2014 |
| * | K073649 | Bengal Stackable Cage SystemSummary page 5…X-MESH™ Cage System (DePuy Spine; K173787, and more) Ocelot Stackable Cage System (DePuy Spine; K140759, and more) Bengal Cage System (DePuy Synthes Spine; K073649, and more) VERTE-STACK™ (Medtronic Sofamor Danek; K070173, and more) Reference CarboClear Pedicle Screw System (Carbo… | 2008 |
| * | K070173 | Verte-Stack Spinal SystemSummary page 5…lot Stackable Cage System (DePuy Spine; K140759, and more) Bengal Cage System (DePuy Synthes Spine; K073649, and more) VERTE-STACK™ (Medtronic Sofamor Danek; K070173, and more) Reference CarboClear Pedicle Screw System (CarboFix Orthopedics Ltd.; K173487, K182377) FORZA® Space… | 2007 |
| † | K173487 | CarboClear® Pedicle Screw System | 2018 |
| † | K182377 | CarboClear® Pedicle Screw System | 2018 |
| † | K152475 | FORZA PTC Spacer System | 2016 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K222874 | CarboClear Cervical Cage System, CarboClear Cervical VBR System | 2023 | 0 |
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 13 companies; a new generation was cleared every 1.0 years on median.
- 24 of the 207 ancestors have a recall of any class.
- Of its descendants, K222874 (Carbofix Orthpedics, Ltd., 2023) has gone furthest, with 0 descendants of its own.
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 CarboClear Vertebral Body Replacement (VBR) System is 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 CarboClear Vertebral Body Replacement device 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 allograft or autograft with the CarboClear Vertebral Body Replacement device is optional.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192214 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192214: CarboClear VBR System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192214
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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