510(k) · Cleared
ClearedCarboClear Lumbar Cage System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
CarboFix Orthopedics, Ltd. · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Mar 2, 2020 as substantially equivalent to K151773 (Medos International SARL, 2015) and 2 other predicates after an 88-day review. Its family tree reaches back 18 generations to 1984. 1 of the 219 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it.
- Decided
- Mar 2, 2020
- Review
- 88 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 18 generations to K841189 (1984). 216 ancestors in all. 2 later devices descend from it, 2 citing it directly. 1 of the 219 devices in this family, counting this one, has a Class I recall.
- Root · 18 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 14 generations between
- 3 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 2 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 1 generation backK151773 CONCORDE Bullet Lumbar Interbody SystemMedos International SARL · 2015
- This deviceK193378 CarboClear Lumbar Cage SystemCarboFix Orthopedics, Ltd. · 2020
- Descendant · cites it directly · 1 of its ownK203683 CarboClear Lumbar Cage SystemCarbofix Orthpedics, Ltd. · 2021
- Descendant · cites it directly · 0 of its ownK222874 CarboClear Cervical Cage System, CarboClear Cervical VBR SystemCarbofix Orthpedics, Ltd. · 2023
Show all 18 generations
- Root · 18 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 17 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 16 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 15 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 14 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 13 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 12 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 11 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 10 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 9 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 8 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 7 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 6 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 5 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 4 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 3 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 2 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 1 generation backK151773 CONCORDE Bullet Lumbar Interbody SystemMedos International SARL · 2015
- This deviceK193378 CarboClear Lumbar Cage SystemCarboFix Orthopedics, Ltd. · 2020
Class I recalls in this family
- K073202 Ardis Spacer3 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 |
|---|---|---|---|---|---|
| −18 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −17 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −16 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −15 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −14 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −13 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −12 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −11 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −10 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −9 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −8 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −7 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −6 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −5 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −4 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −3 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −2 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −1 | K151773 | CONCORDE Bullet Lumbar Interbody System | Medos International SARL | 2015 | — |
| 0 (this device) | K193378 | CarboClear Lumbar Cage System | CarboFix Orthopedics, Ltd. | 2020 | — |
| +1 | K203683 | CarboClear Lumbar Cage System | Carbofix Orthpedics, Ltd. | 2021 | — |
| +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 |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 10 | 0 |
| 2002 | 8 | 0 |
| 2003 | 15 | 0 |
| 2004 | 22 | 0 |
| 2005 | 18 | 0 |
| 2006 | 6 | 0 |
| 2007 | 11 | 0 |
| 2008 | 35 | 1 |
| 2009 | 20 | 0 |
| 2010 | 14 | 0 |
| 2011 | 16 | 0 |
| 2012 | 6 | 0 |
| 2013 | 3 | 0 |
| 2014 | 6 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 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.
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 MAX device
- #1 K203714 NuVasive Thoracolumbar Interbody Systems…score 102.5 · 24 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 |
|---|---|---|---|
| * | K151773 | CONCORDE Bullet Lumbar Interbody SystemSummary page 5…LTD. CARBOCLEAR® LUMBAR CAGE SYSTEM Predicate Devices Primary Predicates CONCORDE® Bullet Lumbar Interbody System (DePuy Spine, Inc.; K151773, and more) Additional Predicates FORZA® PTC Spacer System (Orthofix Inc.; K152475) icotec Interbody Cage System… | 2015 |
| * | K152475 | FORZA PTC Spacer SystemSummary page 5…redicates CONCORDE® Bullet Lumbar Interbody System (DePuy Spine, Inc.; K151773, and more) Additional Predicates FORZA® PTC Spacer System (Orthofix Inc.; K152475) icotec Interbody Cage System (icotec ag; K172480) Reference Devices With regards to the materials incorporated into the s… | 2016 |
| * | K172480 | icotec Interbody Cage SystemSummary page 5…(DePuy Spine, Inc.; K151773, and more) Additional Predicates FORZA® PTC Spacer System (Orthofix Inc.; K152475) icotec Interbody Cage System (icotec ag; K172480) Reference Devices With regards to the materials incorporated into the system components, comparison is also made to the follow… | 2018 |
| † | K192214 | CarboClear VBR System | 2019 |
| † | K173487 | CarboClear® Pedicle Screw System | 2018 |
| † | K182377 | CarboClear® Pedicle Screw System | 2018 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 · 3 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 36 years and passes through 13 companies; a new generation was cleared every 11 months on median.
- 24 of the 216 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K203683 (Carbofix Orthpedics, Ltd., 2021) has gone furthest, with 1 descendant of its own.
- 6 other devices also cite its predicate K151773.
How does its category compare?
All MAX devicesMAX Intervertebral Fusion Device With Bone Graft, Lumbar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · MAX
29in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MAX
85in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MAX
5in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · MAX
811in 2025
MAUDE reports naming product code MAX, 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 | 7 | 86 | 0 | 12 |
| 2008 | 35 | 88 | 2 | 19 |
| 2009 | 31 | 102 | 9 | 90 |
| 2010 | 29 | 137 | 0 | 154 |
| 2011 | 49 | 98 | 3 | 201 |
| 2012 | 48 | 69 | 11 (1) | 327 |
| 2013 | 58 | 102 | 0 | 380 |
| 2014 | 58 | 115 | 3 | 366 |
| 2015 | 53 | 113 | 1 | 524 |
| 2016 | 64 | 124 | 6 | 647 |
| 2017 | 76 | 116 | 1 | 596 |
| 2018 | 64 | 114 | 4 | 616 |
| 2019 | 60 | 131 | 1 | 699 |
| 2020 | 56 | 106 | 0 | 640 |
| 2021 | 53 | 109 | 0 | 622 |
| 2022 | 41 | 95 | 1 | 618 |
| 2023 | 30 | 87 | 0 | 576 |
| 2024 | 38 | 91 | 1 | 729 |
| 2025 | 29 | 85 | 5 | 811 |
| 2026 | 18 | 95 | 0 | — |
What is it indicated for?
The CarboClear® Lumbar Cage System is indicated for intervertebral body fusion of the lumbar spine in skeletally mature patients with degenerative disc disease (DDD), at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The patients may also have up to Grade I spondylolisthesis at the involved levels. CarboClear® Lumbar Cage System is…
Read the full statement (115 words)
The CarboClear® Lumbar Cage System is indicated for intervertebral body fusion of the lumbar spine in skeletally mature patients with degenerative disc disease (DDD), at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The patients may also have up to Grade I spondylolisthesis at the involved levels.
CarboClear® Lumbar Cage System is intended for use with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, and with supplemental fixation cleared for use in the lumbosacral spine.
Patients should have at least six months of non-operative treatment prior to surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K193378 · printed Nov 4, 2026
Cite this page
510(k) Report. “K193378: CarboClear Lumbar Cage System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K193378
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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