510(k) · Cleared
ClearedCarboClear® II 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 Apr 30, 2020 as substantially equivalent to K173487 (CarboFix Orthopedics, Ltd., 2018) and 4 other predicates after a 59-day review. Its family tree reaches back 17 generations to 2004. 11 later devices descend from it.
- Decided
- Apr 30, 2020
- Review
- 59 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 17 generations to K040583 (2004). 221 ancestors in all, the oldest K841189 (1984). 11 later devices descend from it, 1 citing it directly.
- Root · 17 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 13 generations between
- 3 generations backK170543 VIPER PRIME™ Screws with FenestrationsMedos International SARL · 2017
- 2 generations backK173487 CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd. · 2018
- 1 generation backK182377 CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd. · 2018
- This deviceK200519 CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd. · 2020
- Descendant · cites it directly · 10 of its ownK201926 CarboClear® Pedicle Screw System, CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd. · 2020
- Descendant · 2 generations on · 9 of its ownK203317 CarboClear X Pedicle Screw SystemCarboFix Orthopedics, Ltd. · 2020
- Descendant · 2 generations on · 8 of its ownK210716 CarboClear X Pedicle Screw System, CarboClear X Navigated InstrumentsCarboFix Orthopedics, Ltd. · 2021
- Descendant · 3 generations on · 4 of its ownK231280 CarboClear® X Pedicle Screw System; CarboClear® X Navigated…CarboFix Orthopedics, Ltd. · 2023
- Descendant · 2 generations on · 3 of its ownK233944 CarboClear® X Pedicle Screw System; CarboClear® X Navigated…CarboFix Orthopedics, Ltd. · 2024
Show all 17 generations
- Root · 17 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 16 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 15 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
- 14 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 13 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
- 12 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 11 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
- 10 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
- 9 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
- 8 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
- 7 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
- 6 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
- 5 generations backK152604 KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw SetMedtronic Sofamor Danek USA, Incorporated · 2016
- 4 generations backK160879 CONFIDENCE™ High Viscosity Spinal Cement, VIPER® and EXPEDIUM®…Medos International Sàrl · 2016
- 3 generations backK170543 VIPER PRIME™ Screws with FenestrationsMedos International SARL · 2017
- 2 generations backK173487 CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd. · 2018
- 1 generation backK182377 CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd. · 2018
- This deviceK200519 CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd. · 2020
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K201926CarboClear® Pedicle Screw System, CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd. · 2020 · cites it directly10descendants
- K203317CarboClear X Pedicle Screw SystemCarboFix Orthopedics, Ltd. · 2020 · 2 generations on9descendants
- K210716CarboClear X Pedicle Screw System, CarboClear X Navigated InstrumentsCarboFix Orthopedics, Ltd. · 2021 · 2 generations on8descendants
- K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd. · 2023 · 3 generations on4descendants
- K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd. · 2024 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K040583 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −16 | K041118 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −15 | K042025 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2004 | 4 |
| −14 | K043151 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −13 | K050809 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2005 | — |
| −12 | K052187 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −11 | K053101 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −10 | K091442 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2009 | — |
| −9 | K091974 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2009 | 1 |
| −8 | K102555 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2010 | — |
| −7 | K112473 | CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2011 | — |
| −6 | K113174 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2011 | 1 |
| −5 | K152604 | KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw Set | Medtronic Sofamor Danek USA, Incorporated | 2016 | — |
| −4 | K160879 | CONFIDENCE™ High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated… | Medos International Sàrl | 2016 | — |
| −3 | K170543 | VIPER PRIME™ Screws with Fenestrations | Medos International SARL | 2017 | — |
| −2 | K173487 | CarboClear® Pedicle Screw System | CarboFix Orthopedics, Ltd. | 2018 | — |
| −1 | K182377 | CarboClear® Pedicle Screw System | CarboFix Orthopedics, Ltd. | 2018 | — |
| 0 (this device) | K200519 | CarboClear® II Pedicle Screw System | CarboFix Orthopedics, Ltd. | 2020 | — |
| +1 | K201926 | CarboClear® Pedicle Screw System, CarboClear® II Pedicle Screw System | CarboFix Orthopedics, Ltd. | 2020 | — |
| +2 | K203317 | CarboClear X Pedicle Screw System | CarboFix Orthopedics, Ltd. | 2020 | — |
| +2 | K210716 | CarboClear X Pedicle Screw System, CarboClear X Navigated Instruments | CarboFix Orthopedics, Ltd. | 2021 | — |
| +3 | K231280 | CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments… | CarboFix Orthopedics, Ltd. | 2023 | — |
| +2 | K233944 | CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments | CarboFix Orthopedics, Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1990 | 2 | 0 |
| 1992 | 5 | 0 |
| 1993 | 2 | 0 |
| 1994 | 3 | 0 |
| 1995 | 6 | 0 |
| 1996 | 6 | 0 |
| 1997 | 6 | 0 |
| 1998 | 12 | 0 |
| 1999 | 13 | 0 |
| 2000 | 10 | 0 |
| 2001 | 15 | 0 |
| 2002 | 15 | 0 |
| 2003 | 14 | 0 |
| 2004 | 22 | 0 |
| 2005 | 19 | 0 |
| 2006 | 14 | 0 |
| 2007 | 8 | 0 |
| 2008 | 9 | 0 |
| 2009 | 4 | 0 |
| 2010 | 4 | 0 |
| 2011 | 3 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 5 | 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 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 |
|---|---|---|---|
| * | K173487 | CarboClear® Pedicle Screw SystemSummary page 5…K200519 - Page 2 of 3 Predicate Devices Primary Predicate Device ƒ CarboClear Pedicle Screw System (CarboFix Orthopedics Ltd.; K173487, K182377) Additional Predicate Devices ƒ S4® Spinal System (Aesculap Spine; K130291 and more) ƒ CD Horizon Pedic… | 2018 |
| * | K182377 | CarboClear® Pedicle Screw SystemSummary page 5…K200519 - Page 2 of 3 Predicate Devices Primary Predicate Device ƒ CarboClear Pedicle Screw System (CarboFix Orthopedics Ltd.; K173487, K182377) Additional Predicate Devices ƒ S4® Spinal System (Aesculap Spine; K130291 and more) ƒ CD Horizon Pedicle Screws (Medt… | 2018 |
| * | K130291 | S4 Spinal SystemSummary page 5…Device ƒ CarboClear Pedicle Screw System (CarboFix Orthopedics Ltd.; K173487, K182377) Additional Predicate Devices ƒ S4® Spinal System (Aesculap Spine; K130291 and more) ƒ CD Horizon Pedicle Screws (Medtronic; K182928 and more) ƒ Mesa Spinal System (K2M, Inc.; K052398 and more)… | 2013 |
| * | K182928 | CD Horizon™ Spinal SystemSummary page 5…dics Ltd.; K173487, K182377) Additional Predicate Devices ƒ S4® Spinal System (Aesculap Spine; K130291 and more) ƒ CD Horizon Pedicle Screws (Medtronic; K182928 and more) ƒ Mesa Spinal System (K2M, Inc.; K052398 and more) Reference Device ƒ Piccolo Composite Nailing Systems (Car… | 2019 |
| * | K052398 | Mesa Spinal SystemSummary page 5…Devices ƒ S4® Spinal System (Aesculap Spine; K130291 and more) ƒ CD Horizon Pedicle Screws (Medtronic; K182928 and more) ƒ Mesa Spinal System (K2M, Inc.; K052398 and more) Reference Device ƒ Piccolo Composite Nailing Systems (CarboFix Orthopedics Ltd.; K102369, K123810 and more)… | 2005 |
| † | K102369 | Piccolo Composite Nailing System | 2011 |
| † | K123810 | Piccolo Composite Ankle Arthrodesis Nailing System | 2013 |
What descends from it? (11)
See all 111 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K201926 | CarboClear® Pedicle Screw System, CarboClear® II Pedicle Screw System | 2020 | 10 |
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 16 years and passes through 7 companies; a new generation was cleared every 4 months on median.
- 25 of the 221 ancestors have a recall of any class.
- Of its descendants, K201926 (CarboFix Orthopedics, Ltd., 2020) has gone furthest, with 10 descendants of its own.
- 8 other devices also cite its predicate K173487.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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® II 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/K200519 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200519: CarboClear® II 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/K200519
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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