510(k) · Cleared
ClearedCarboClear X Pedicle Screw System, CarboClear X Navigated Instruments
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 6, 2021 as substantially equivalent to K203317 (CarboFix Orthopedics, Ltd., 2020) and 9 other predicates after a 27-day review. Its family tree reaches back 20 generations to 2004. 8 later devices descend from it.
- Decided
- Apr 6, 2021
- Review
- 27 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 10
Its longest line of descent runs back 20 generations to K040583 (2004). 362 ancestors in all, the oldest K841189 (1984). 8 later devices descend from it, 5 citing it directly.
- Root · 20 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 16 generations between
- 3 generations backK200519 CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd. · 2020
- 2 generations backK201926 CarboClear® Pedicle Screw System, CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd. · 2020
- 1 generation backK203317 CarboClear X Pedicle Screw SystemCarboFix Orthopedics, Ltd. · 2020
- This deviceK210716 CarboClear X Pedicle Screw System, CarboClear X Navigated InstrumentsCarboFix Orthopedics, Ltd. · 2021
- Descendant · cites it directly · 4 of its ownK231280 CarboClear® X Pedicle Screw System; CarboClear® X Navigated…CarboFix Orthopedics, Ltd. · 2023
- Descendant · cites it directly · 3 of its ownK233944 CarboClear® X Pedicle Screw System; CarboClear® X Navigated…CarboFix Orthopedics, Ltd. · 2024
- Descendant · cites it directly · 2 of its ownK240846 CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid…CarboFix Orthopedics, Ltd. · 2024
- Descendant · cites it directly · 2 of its ownK233989 CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd. · 2024
- Descendant · 2 generations on · 1 of its ownK252327 CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG · 2025
Show all 20 generations
- Root · 20 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 19 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 18 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
- 17 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 16 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
- 15 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 14 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
- 13 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
- 12 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
- 11 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
- 10 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
- 9 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
- 8 generations backK152604 KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw SetMedtronic Sofamor Danek USA, Incorporated · 2016
- 7 generations backK160879 CONFIDENCE™ High Viscosity Spinal Cement, VIPER® and EXPEDIUM®…Medos International Sàrl · 2016
- 6 generations backK170543 VIPER PRIME™ Screws with FenestrationsMedos International SARL · 2017
- 5 generations backK173487 CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd. · 2018
- 4 generations backK182377 CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd. · 2018
- 3 generations backK200519 CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd. · 2020
- 2 generations backK201926 CarboClear® Pedicle Screw System, CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd. · 2020
- 1 generation backK203317 CarboClear X Pedicle Screw SystemCarboFix Orthopedics, Ltd. · 2020
- This deviceK210716 CarboClear X Pedicle Screw System, CarboClear X Navigated InstrumentsCarboFix Orthopedics, Ltd. · 2021
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd. · 2023 · cites it directly4descendants
- K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd. · 2024 · cites it directly3descendants
- K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd. · 2024 · cites it directly2descendants
- K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd. · 2024 · cites it directly2descendants
- K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG · 2025 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −20 | K040583 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −19 | K041118 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −18 | K042025 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2004 | 4 |
| −17 | K043151 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −16 | K050809 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2005 | — |
| −15 | K052187 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −14 | K053101 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −13 | K091442 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2009 | — |
| −12 | K091974 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2009 | 1 |
| −11 | K102555 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2010 | — |
| −10 | K112473 | CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2011 | — |
| −9 | K113174 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2011 | 1 |
| −8 | K152604 | KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw Set | Medtronic Sofamor Danek USA, Incorporated | 2016 | — |
| −7 | K160879 | CONFIDENCE™ High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated… | Medos International Sàrl | 2016 | — |
| −6 | K170543 | VIPER PRIME™ Screws with Fenestrations | Medos International SARL | 2017 | — |
| −5 | K173487 | CarboClear® Pedicle Screw System | CarboFix Orthopedics, Ltd. | 2018 | — |
| −4 | K182377 | CarboClear® Pedicle Screw System | CarboFix Orthopedics, Ltd. | 2018 | — |
| −3 | K200519 | CarboClear® II Pedicle Screw System | CarboFix Orthopedics, Ltd. | 2020 | — |
| −2 | K201926 | CarboClear® Pedicle Screw System, CarboClear® II Pedicle Screw System | CarboFix Orthopedics, Ltd. | 2020 | — |
| −1 | K203317 | CarboClear X Pedicle Screw System | CarboFix Orthopedics, Ltd. | 2020 | — |
| 0 (this device) | K210716 | CarboClear X Pedicle Screw System, CarboClear X Navigated Instruments | CarboFix Orthopedics, Ltd. | 2021 | — |
| +1 | K231280 | CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments… | CarboFix Orthopedics, Ltd. | 2023 | — |
| +1 | K233944 | CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments | CarboFix Orthopedics, Ltd. | 2024 | — |
| +1 | K240846 | CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated… | CarboFix Orthopedics, Ltd. | 2024 | — |
| +1 | K233989 | CarboClear® Posterior Cervical Screw System | CarboFix Orthopedics, Ltd. | 2024 | — |
| +2 | K252327 | CMORE® CT System; CMORE® CT System Navigated Instruments | Icotec AG | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 2 | 0 |
| 1985 | 2 | 0 |
| 1986 | 2 | 0 |
| 1987 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 1 | 0 |
| 1990 | 3 | 0 |
| 1992 | 7 | 0 |
| 1993 | 3 | 0 |
| 1994 | 7 | 0 |
| 1995 | 13 | 0 |
| 1996 | 10 | 0 |
| 1997 | 11 | 0 |
| 1998 | 17 | 0 |
| 1999 | 19 | 0 |
| 2000 | 19 | 0 |
| 2001 | 24 | 0 |
| 2002 | 21 | 0 |
| 2003 | 21 | 0 |
| 2004 | 32 | 0 |
| 2005 | 27 | 0 |
| 2006 | 18 | 0 |
| 2007 | 14 | 0 |
| 2008 | 16 | 0 |
| 2009 | 5 | 0 |
| 2010 | 8 | 0 |
| 2011 | 7 | 0 |
| 2012 | 6 | 0 |
| 2013 | 6 | 0 |
| 2014 | 5 | 0 |
| 2015 | 5 | 0 |
| 2016 | 4 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (10)
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 |
|---|---|---|---|
| * | K203317 | CarboClear X Pedicle Screw SystemSummary page 6…K210716 Page 2 of 4 CARBOFIX ORTHOPEDICS LTD. Predicate Devices Primary Predicate Device: 1. CarboClear( X Pedicle Screw System (CarboFix Orthopedics Ltd.; K203317) 2. CarboClear R navigated Instruments (CarboFix Orthopedics Ltd.; K201251) Additional Predicate Devices: 1. For Ca… | 2020 |
| * | K201251 | CarboClear Navigated InstrumentsSummary page 6…Predicate Device: 1. CarboClear( X Pedicle Screw System (CarboFix Orthopedics Ltd.; K203317) 2. CarboClear R navigated Instruments (CarboFix Orthopedics Ltd.; K201251) Additional Predicate Devices: 1. For CarboClear®X Pedicle Screw System: * CD HORIZONo Spinal System (Medtroni… | 2020 |
| * | K981676 | CD Horizon Spinal SystemSummary page 6…thopedics Ltd.; K201251) Additional Predicate Devices: 1. For CarboClear®X Pedicle Screw System: * CD HORIZONo Spinal System (Medtronic Sofamor Danek; K981676 and more) * S4R Spinal System (Aesculap Spine; Kl30291 and more) * Click's System (Synthes (D… | 1999 |
| * | K130291 | S4 Spinal System | 2013 |
| * | K992739 | Click'xSummary page 6…onic Sofamor Danek; K981676 and more) * S4R Spinal System (Aesculap Spine; Kl30291 and more) * Click's System (Synthes (DePuy Spine); K992739 and more) * Mesa Spinal System (K2M; K052398 and more) * CarboClearIe Pedicle Screw System (CarboFix Orthoped… | 2000 |
| * | K052398 | Mesa Spinal SystemSummary page 6…* S4R Spinal System (Aesculap Spine; Kl30291 and more) * Click's System (Synthes (DePuy Spine); K992739 and more) * Mesa Spinal System (K2M; K052398 and more) * CarboClearIe Pedicle Screw System (CarboFix Orthopedics Ltd.; K173487, K182377, K201926)… | 2005 |
| * | K173487 | CarboClear® Pedicle Screw SystemSummary page 6…Synthes (DePuy Spine); K992739 and more) * Mesa Spinal System (K2M; K052398 and more) * CarboClearIe Pedicle Screw System (CarboFix Orthopedics Ltd.; K173487, K182377, K201926) 2. For CarboClear®X Navigated Instruments: Medtronic Navigated Instruments… | 2018 |
| * | K182377 | CarboClear® Pedicle Screw SystemSummary page 6…; K992739 and more) * Mesa Spinal System (K2M; K052398 and more) * CarboClearIe Pedicle Screw System (CarboFix Orthopedics Ltd.; K173487, K182377, K201926) 2. For CarboClear®X Navigated Instruments: Medtronic Navigated Instruments (Medtronic Sofamor Da… | 2018 |
| * | K201926 | CarboClear® Pedicle Screw System, CarboClear® II Pedicle Screw SystemSummary page 6…and more) * Mesa Spinal System (K2M; K052398 and more) * CarboClearIe Pedicle Screw System (CarboFix Orthopedics Ltd.; K173487, K182377, K201926) 2. For CarboClear®X Navigated Instruments: Medtronic Navigated Instruments (Medtronic Sofamor Danek; K153… | 2020 |
| * | K153442 | CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with…Summary page 6…Ltd.; K173487, K182377, K201926) 2. For CarboClear®X Navigated Instruments: Medtronic Navigated Instruments (Medtronic Sofamor Danek; K153442 and more) Reference Device (for CarboClearX®Pedicle Screw System): * Piccolo Composite Nailing System (CarboFix… | 2016 |
| † | K151010 | Piccolo Composite Nailing System | 2015 |
What descends from it? (8)
5 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K231280 | CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X… | 2023 | 4 |
| K233944 | CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments | 2024 | 3 |
| K240846 | CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments… | 2024 | 2 |
| K233989 | CarboClear® Posterior Cervical Screw System | 2024 | 2 |
| K233793 | CarboClear® X Pedicle Screw System | 2024 | 1 |
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 17 years and passes through 7 companies; a new generation was cleared every 4 months on median.
- 40 of the 362 ancestors have a recall of any class.
- Of its descendants, K231280 (CarboFix Orthopedics, Ltd., 2023) has gone furthest, with 4 descendants of its own.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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@ X 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. CarboClear@ X Navigated Instruments are intended to be used during the preparation and placement of CarboClear@ X Pedicle Screws during…
Read the full statement (143 words)
The CarboClear@ X 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.
CarboClear@ X Navigated Instruments are intended to be used during the preparation and placement of CarboClear@ X Pedicle Screws during spinal surgery to assist the surgeon in precisely locating anatomical structures. CarboClear@ X Navigated Instruments are designed for use with the Medtronic StealthStation® System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K210716 · printed Nov 5, 2026
Cite this page
510(k) Report. “K210716: CarboClear X Pedicle Screw System, CarboClear X Navigated Instruments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K210716
Report an extraction error
Are you the manufacturer?
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