510(k) · Cleared
ClearedCarboClear Cervical Cage System, CarboClear Cervical VBR System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Carbofix Orthpedics, Ltd. · ODP Intervertebral Fusion Device With Bone Graft, Cervical
Cleared on Jul 26, 2023 as substantially equivalent to K160154 (Astura Medical, 2016) and 4 other predicates after a 307-day review. Its family tree reaches back 22 generations to 1984. 1 of the 353 devices in its family, counting itself, has a Class I recall.
- Decided
- Jul 26, 2023
- Review
- 307 days
- Class
- Class II
- Product code
- ODP
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 22 generations to K841189 (1984). 352 ancestors in all, the oldest K792352 (1979). No later device cites it as a predicate yet. 1 of the 353 devices in this family, counting this one, has a Class I recall.
- Root · 22 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 18 generations between
- 3 generations backK162103 Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™…Choicespine, LP · 2016
- 2 generations backK171686 Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) SystemChoicespine · 2017
- 1 generation backK183588 Choice Spine Hawkeye Vertebral Body Replacement (VBR) SystemChoicespine · 2019
- This deviceK222874 CarboClear Cervical Cage System, CarboClear Cervical VBR SystemCarbofix Orthpedics, Ltd. · 2023
Show all 22 generations
- Root · 22 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 21 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 20 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 19 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 18 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 17 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 16 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 15 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 14 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 13 generations backK080083 Intrepid Spinal SystemMedtronic Sofamor Danek · 2008 · Recalled
- 12 generations backK073109 Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008
- 11 generations backK081849 Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc. · 2008 · Recalled
- 10 generations backK091301 Life Spine Stand-Alone Spacer SystemLife Spine · 2009
- 9 generations backK100802 Aesculap Implant Systems Sibd Spinal SystemAesculap Implant Systems, Inc. · 2010
- 8 generations backK111122 Aesculap Sibd XP Spinal SystemAesculap Implant Systems, Inc. · 2011
- 7 generations backK141942 Midline II TICentinel Spine, Inc. · 2014
- 6 generations backK150643 Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-TiCentinel Spine, Inc. · 2015
- 5 generations backK152475 FORZA PTC Spacer SystemOrthofix, Inc. · 2016
- 4 generations backK153495 Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF…Ldr Spine USA · 2016 · Recalled
- 3 generations backK162103 Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™…Choicespine, LP · 2016
- 2 generations backK171686 Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) SystemChoicespine · 2017
- 1 generation backK183588 Choice Spine Hawkeye Vertebral Body Replacement (VBR) SystemChoicespine · 2019
- This deviceK222874 CarboClear Cervical Cage System, CarboClear Cervical VBR SystemCarbofix Orthpedics, Ltd. · 2023
Class I recalls in this family
- K073202 Ardis Spacer4 generations back · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −22 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −21 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −20 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −19 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −18 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −17 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −16 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −15 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −14 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −13 | K080083 | Intrepid Spinal System | Medtronic Sofamor Danek | 2008 | 8 |
| −12 | K073109 | Stalif TT Intervertebral Body Fusion System | Surgicraft, Ltd. | 2008 | — |
| −11 | K081849 | Blackstone Pillar SA Partial Vertebral Body Replacement Device | Blackstone Medical, Inc. | 2008 | 1 |
| −10 | K091301 | Life Spine Stand-Alone Spacer System | Life Spine | 2009 | — |
| −9 | K100802 | Aesculap Implant Systems Sibd Spinal System | Aesculap Implant Systems, Inc. | 2010 | — |
| −8 | K111122 | Aesculap Sibd XP Spinal System | Aesculap Implant Systems, Inc. | 2011 | — |
| −7 | K141942 | Midline II TI | Centinel Spine, Inc. | 2014 | — |
| −6 | K150643 | Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-Ti | Centinel Spine, Inc. | 2015 | — |
| −5 | K152475 | FORZA PTC Spacer System | Orthofix, Inc. | 2016 | — |
| −4 | K153495 | Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage… | Ldr Spine USA | 2016 | 1 |
| −3 | K162103 | Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice… | Choicespine, LP | 2016 | — |
| −2 | K171686 | Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) System | Choicespine | 2017 | — |
| −1 | K183588 | Choice Spine Hawkeye Vertebral Body Replacement (VBR) System | Choicespine | 2019 | — |
| 0 (this device) | 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 |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1990 | 1 | 0 |
| 1996 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 10 | 0 |
| 2002 | 8 | 0 |
| 2003 | 16 | 0 |
| 2004 | 26 | 0 |
| 2005 | 21 | 0 |
| 2006 | 13 | 0 |
| 2007 | 15 | 0 |
| 2008 | 44 | 1 |
| 2009 | 30 | 0 |
| 2010 | 22 | 0 |
| 2011 | 33 | 0 |
| 2012 | 20 | 0 |
| 2013 | 18 | 0 |
| 2014 | 19 | 0 |
| 2015 | 14 | 0 |
| 2016 | 5 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 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 ODP device
- #1 K222276 CONDUIT Cages; FIBERGRAFT BG Puttyscore 53.4 · 25 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 |
|---|---|---|---|
| * | K160154 | ALTA Anterior Cervical Interbody SpacerSummary page 6…el 1. ODP; Orthopedic 2. PLR; Orthopedic Predicate Devices Primary 1. For CarboClear Cervical Cage System - ALTA Cervical Interbody Spacer (Astura Medical; K160154, and more) 2. For CarboClear Cervical VBR System - HAWKEYE™ Vertebral Body Replacement (VBR) System (Choice Spine; K18358… | 2016 |
| * | K183588 | Choice Spine Hawkeye Vertebral Body Replacement (VBR) SystemSummary page 6…nterbody Spacer (Astura Medical; K160154, and more) 2. For CarboClear Cervical VBR System - HAWKEYE™ Vertebral Body Replacement (VBR) System (Choice Spine; K183588) Additional 1. CarboClear Lumbar Cage System (CarboFix Orthopedics Ltd.; K193378, K203683) 2. CarboClear VBR System (… | 2019 |
| * | K193378 | CarboClear Lumbar Cage SystemSummary page 6…l VBR System - HAWKEYE™ Vertebral Body Replacement (VBR) System (Choice Spine; K183588) Additional 1. CarboClear Lumbar Cage System (CarboFix Orthopedics Ltd.; K193378, K203683) 2. CarboClear VBR System (CarboFix Orthopedics Ltd.; K192214) Indications for Use CarboClear Cervical Cage Sy… | 2020 |
| * | K203683 | CarboClear Lumbar Cage SystemSummary page 6…HAWKEYE™ Vertebral Body Replacement (VBR) System (Choice Spine; K183588) Additional 1. CarboClear Lumbar Cage System (CarboFix Orthopedics Ltd.; K193378, K203683) 2. CarboClear VBR System (CarboFix Orthopedics Ltd.; K192214) Indications for Use CarboClear Cervical Cage System The CarboC… | 2021 |
| * | K192214 | CarboClear VBR SystemSummary page 6…pine; K183588) Additional 1. CarboClear Lumbar Cage System (CarboFix Orthopedics Ltd.; K193378, K203683) 2. CarboClear VBR System (CarboFix Orthopedics Ltd.; K192214) Indications for Use CarboClear Cervical Cage System The CarboClear Cervical Cage System is indicated for intervertebral body f… | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
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 · 4 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 39 years and passes through 18 companies; a new generation was cleared every 10 months on median.
- 44 of the 352 ancestors have a recall of any class; 1 has a Class I recall.
- 4 other devices also cite its predicate K160154.
How does its category compare?
All ODP devicesODP Intervertebral Fusion Device With Bone Graft, Cervical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · ODP
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ODP
87in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ODP
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ODP
57in 2025
MAUDE reports naming product code ODP, 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 | 0 | — | 0 | 0 |
| 2008 | 8 | 89 | 0 | 2 |
| 2009 | 12 | 127 | 1 | 21 |
| 2010 | 9 | 151 | 0 | 54 |
| 2011 | 25 | 113 | 1 | 38 |
| 2012 | 17 | 93 | 0 | 92 |
| 2013 | 18 | 187 | 1 | 78 |
| 2014 | 26 | 118 | 0 | 43 |
| 2015 | 24 | 180 | 0 | 51 |
| 2016 | 17 | 112 | 0 | 37 |
| 2017 | 33 | 104 | 0 | 39 |
| 2018 | 25 | 133 | 0 | 51 |
| 2019 | 22 | 92 | 0 | 141 |
| 2020 | 14 | 89 | 1 | 86 |
| 2021 | 18 | 121 | 0 | 161 |
| 2022 | 12 | 92 | 0 | 50 |
| 2023 | 34 | 165 | 0 | 36 |
| 2024 | 10 | 76 | 0 | 55 |
| 2025 | 11 | 87 | 2 | 57 |
| 2026 | 19 | 117 | 0 | — |
What is it indicated for?
The CarboClear Cervical Cage System is indicated for intervertebral body fusion procedures of the cervical spine in skeletally mature patients with degenerative disc disease (DDD) at levels C2 — T1. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The implants are to be implanted via an open, anterior approach and packed with autograft and/or allograft comprised of cancellous…
Read the full statement (301 words)
The CarboClear Cervical Cage System is indicated for intervertebral body fusion procedures of the cervical spine in skeletally mature patients with degenerative disc disease (DDD) at levels C2 — T1. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.
The implants are to be implanted via an open, anterior approach and packed with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft.
This device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the cervical spine.
Patients should receive at least six (6) weeks of non-operative treatment prior to treatment with the CarboClear Cervical Cage System.
The CarboClear Cervical Vertebral Body Replacement (VBR) System Spacers are vertebral body replacement devices intended for use in the cervical spine (C2 — T1).
The CarboClear Cervical VBR devices are intended for use in skeletally mature patients to replace a diseased or damaged vertebral body caused by tumor, fracture, or osteomyelitis, or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders. The spacers are 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 spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon’s discretion.
The devices are intended to be used with supplemental internal spinal fixation systems that have been labeled for use in the cervical spine (i.e., posterior screw and rod systems, and anterior plate systems).
When used at more than two levels, supplemental fixation should include posterior fixation.
The use of allograft or autograft with the CarboClear Cervical VBR device 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/K222874 · printed Nov 4, 2026
Cite this page
510(k) Report. “K222874: CarboClear Cervical Cage System, CarboClear Cervical VBR System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K222874
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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