510(k) · Cleared
ClearedCarboClear® Pedicle Screw System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
CarboFix Orthopedics, Ltd. · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Jul 18, 2018 as substantially equivalent to K052398 (K2m, LLC, 2005) and 4 other predicates after a 247-day review. Its family tree reaches back 15 generations to 2004. 41 later devices descend from it.
- Decided
- Jul 18, 2018
- Review
- 247 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 15 generations to K040583 (2004). 90 ancestors in all, the oldest K841189 (1984). 41 later devices descend from it, 9 citing it directly.
- Root · 15 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 11 generations between
- 3 generations backK152604 KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw SetMedtronic Sofamor Danek USA, Incorporated · 2016
- 2 generations backK160879 CONFIDENCE™ High Viscosity Spinal Cement, VIPER® and EXPEDIUM®…Medos International Sàrl · 2016
- 1 generation backK170543 VIPER PRIME™ Screws with FenestrationsMedos International SARL · 2017
- This deviceK173487 CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd. · 2018
- Descendant · cites it directly · 39 of its ownK182377 CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd. · 2018
- Descendant · 2 generations on · 29 of its ownK190545 VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG · 2019 · Recalled
- Descendant · cites it directly · 28 of its ownK190526 High V+ Bone Cement, CarboClear® Fenestrated Pedicle ScrewsCarboFix Orthopedics, Ltd. · 2019
- Descendant · 2 generations on · 27 of its ownK200596 G21 Cement, VADER® Pedicle SystemIcotec AG · 2020 · Recalled
- Descendant · 3 generations on · 14 of its ownK221926 Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc. · 2022
Show all 15 generations
- Root · 15 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 14 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 13 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
- 12 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 11 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
- 10 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 9 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
- 8 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
- 7 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
- 6 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
- 5 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
- 4 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
- 3 generations backK152604 KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw SetMedtronic Sofamor Danek USA, Incorporated · 2016
- 2 generations backK160879 CONFIDENCE™ High Viscosity Spinal Cement, VIPER® and EXPEDIUM®…Medos International Sàrl · 2016
- 1 generation backK170543 VIPER PRIME™ Screws with FenestrationsMedos International SARL · 2017
- This deviceK173487 CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd. · 2018
Showing 5 of 41 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 41 · See all- K182377CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd. · 2018 · cites it directly39descendants
- K190545VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG · 2019 · 2 generations on29descendants
- K190526High V+ Bone Cement, CarboClear® Fenestrated Pedicle ScrewsCarboFix Orthopedics, Ltd. · 2019 · cites it directly28descendants
- K200596G21 Cement, VADER® Pedicle SystemIcotec AG · 2020 · 2 generations on27descendants
- K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc. · 2022 · 3 generations on14descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K040583 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −14 | K041118 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −13 | K042025 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2004 | 4 |
| −12 | K043151 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −11 | K050809 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2005 | — |
| −10 | K052187 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −9 | K053101 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −8 | K091442 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2009 | — |
| −7 | K091974 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2009 | 1 |
| −6 | K102555 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2010 | — |
| −5 | K112473 | CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2011 | — |
| −4 | K113174 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2011 | 1 |
| −3 | K152604 | KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw Set | Medtronic Sofamor Danek USA, Incorporated | 2016 | — |
| −2 | K160879 | CONFIDENCE™ High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated… | Medos International Sàrl | 2016 | — |
| −1 | K170543 | VIPER PRIME™ Screws with Fenestrations | Medos International SARL | 2017 | — |
| 0 (this device) | K173487 | CarboClear® Pedicle Screw System | CarboFix Orthopedics, Ltd. | 2018 | — |
| +1 | K182377 | CarboClear® Pedicle Screw System | CarboFix Orthopedics, Ltd. | 2018 | — |
| +2 | K190545 | VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0 | Icotec AG | 2019 | 1 |
| +1 | K190526 | High V+ Bone Cement, CarboClear® Fenestrated Pedicle Screws | CarboFix Orthopedics, Ltd. | 2019 | — |
| +2 | K200596 | G21 Cement, VADER® Pedicle System | Icotec AG | 2020 | 1 |
| +3 | K221926 | Invictus® Bone Cement, Invictus Spinal Fixation System | Alphatec Spine, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 4 | 0 |
| 2001 | 7 | 0 |
| 2002 | 5 | 0 |
| 2003 | 6 | 0 |
| 2004 | 18 | 0 |
| 2005 | 10 | 0 |
| 2006 | 6 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 6 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 8 | 0 |
| 2024 | 10 | 0 |
| 2025 | 6 | 0 |
| 2026 | 6 | 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 NKB? 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 NKB device
- #1 K223494 CD Horizon Spinal Systemscore 40.4 · 30 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 |
|---|---|---|---|
| * | K052398 | Mesa Spinal SystemSummary page 5…K173487 - Page 2 of 3 Predicate Devices Primary Predicate: ƒ Mesa Spinal System (K2M, Inc.; K052398 and more) Additional Predicates: ƒ CD HORIZON® Fenestrated Screw Set (Medtronic Sofamor Danek; K152604, K170347) ƒ… | 2005 |
| * | K152604 | KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw SetSummary page 5…ices Primary Predicate: ƒ Mesa Spinal System (K2M, Inc.; K052398 and more) Additional Predicates: ƒ CD HORIZON® Fenestrated Screw Set (Medtronic Sofamor Danek; K152604, K170347) ƒ VIPER® and EXPEDIUM® Fenestrated Screw Systems (DePuy Spine, Inc.; K160879, K170543) Indications fo… | 2016 |
| * | K170347 | CD HORIZON™ Fenestrated Screw SetSummary page 5…edicate: ƒ Mesa Spinal System (K2M, Inc.; K052398 and more) Additional Predicates: ƒ CD HORIZON® Fenestrated Screw Set (Medtronic Sofamor Danek; K152604, K170347) ƒ VIPER® and EXPEDIUM® Fenestrated Screw Systems (DePuy Spine, Inc.; K160879, K170543) Indications for Use The Carbo… | 2017 |
| * | K160879 | CONFIDENCE™ High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated Screw SystemsSummary page 5…ƒ CD HORIZON® Fenestrated Screw Set (Medtronic Sofamor Danek; K152604, K170347) ƒ VIPER® and EXPEDIUM® Fenestrated Screw Systems (DePuy Spine, Inc.; K160879, K170543) Indications for Use The CarboClear Pedicle Screw System is intended to restore the integrity of the spinal column eve… | 2016 |
| * | K170543 | VIPER PRIME™ Screws with FenestrationsSummary page 5…HORIZON® Fenestrated Screw Set (Medtronic Sofamor Danek; K152604, K170347) ƒ VIPER® and EXPEDIUM® Fenestrated Screw Systems (DePuy Spine, Inc.; K160879, K170543) Indications for Use The CarboClear Pedicle Screw System is intended to restore the integrity of the spinal column even in the… | 2017 |
What descends from it? (41)
See all 419 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K182377 | CarboClear® Pedicle Screw System | 2018 | 39 |
| K190526 | High V+ Bone Cement, CarboClear® Fenestrated Pedicle Screws | 2019 | 28 |
| K200519 | CarboClear® II Pedicle Screw System | 2020 | 11 |
| K201926 | CarboClear® Pedicle Screw System, CarboClear® II Pedicle Screw System | 2020 | 10 |
| K203317 | CarboClear X Pedicle Screw System | 2020 | 9 |
| K201251 | CarboClear Navigated Instruments | 2020 | 9 |
| K210716 | CarboClear X Pedicle Screw System, CarboClear X Navigated Instruments | 2021 | 8 |
| K232341 | CarboClear® Pedicle Screw System | 2023 | 4 |
| K233944 | CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments | 2024 | 3 |
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 14 years and passes through 7 companies; a new generation was cleared every 4 months on median.
- 17 of the 90 ancestors have a recall of any class.
- Of its descendants, K182377 (CarboFix Orthopedics, Ltd., 2018) has gone furthest, with 39 descendants of its own.
- 16 other devices also cite its predicate K052398.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · NKB
24in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NKB
61in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NKB
1in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · NKB
1,171in 2025
MAUDE reports naming product code NKB, 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 | 38 | 87 | 4 | 34 |
| 2008 | 36 | 59 | 5 | 82 |
| 2009 | 44 | 71 | 33 | 171 |
| 2010 | 37 | 111 | 4 | 462 |
| 2011 | 48 | 84 | 3 | 577 |
| 2012 | 60 | 79 | 13 | 1,747 |
| 2013 | 35 | 73 | 0 | 1,962 |
| 2014 | 46 | 90 | 3 (1) | 1,671 |
| 2015 | 55 | 90 | 3 | 1,446 |
| 2016 | 50 | 84 | 1 | 1,585 |
| 2017 | 63 | 69 | 1 | 1,618 |
| 2018 | 56 | 61 | 3 | 1,684 |
| 2019 | 39 | 84 | 1 | 1,915 |
| 2020 | 48 | 68 | 1 | 2,076 |
| 2021 | 32 | 61 | 0 | 1,745 |
| 2022 | 34 | 88 | 5 | 1,339 |
| 2023 | 44 | 72 | 2 | 919 |
| 2024 | 39 | 57 | 3 | 1,614 |
| 2025 | 24 | 61 | 1 | 1,171 |
| 2026 | 30 | 91 | 3 | — |
What is it indicated for?
The CarboClear Pedicle Screw System is 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 thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173487 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173487: CarboClear® Pedicle Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173487
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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