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 Jan 10, 2024 as substantially equivalent to K232341 (CarboFix Orthopedics, Ltd., 2023) and 6 other predicates after a 27-day review. Its family tree reaches back 22 generations to 2004. 2 of the 641 devices in its family, counting itself, have a Class I recall. 3 later devices descend from it.
- Decided
- Jan 10, 2024
- Review
- 27 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 22 generations to K040583 (2004). 637 ancestors in all, the oldest K781443 (1978). 3 later devices descend from it, 2 citing it directly. 2 of the 641 devices in this family, counting this one, have a Class I recall.
- Root · 22 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 18 generations between
- 3 generations backK190526 High V+ Bone Cement, CarboClear® Fenestrated Pedicle ScrewsCarboFix Orthopedics, Ltd. · 2019
- 2 generations backK200596 G21 Cement, VADER® Pedicle SystemIcotec AG · 2020 · Recalled
- 1 generation backK231280 CarboClear® X Pedicle Screw System; CarboClear® X Navigated…CarboFix Orthopedics, Ltd. · 2023
- This deviceK233944 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 · 1 of its ownK233793 CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd. · 2024
- Descendant · 2 generations on · 0 of its ownK243106 CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd. · 2024
Show all 22 generations
- Root · 22 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 21 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 20 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
- 19 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 18 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
- 17 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 16 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
- 15 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
- 14 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
- 13 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
- 12 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
- 11 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
- 10 generations backK121680 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
- 9 generations backK131321 CD Horizon Spinal SystemMedtronic Sofamor Danek USA · 2013
- 8 generations backK132111 CD Horizon Spinal SystemMedtronic Sofamor Danek USA · 2013
- 7 generations backK141604 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2014
- 6 generations backK143684 NuVasive Reline SystemNu Vasive, Incorporated · 2015
- 5 generations backK160989 NuVasive® Reline® SystemNu Vasive, Incorporated · 2016
- 4 generations backK180498 NuVasive Reline Fenestrated Screws, High V+ Bone CementNu Vasive, Incorporated · 2018
- 3 generations backK190526 High V+ Bone Cement, CarboClear® Fenestrated Pedicle ScrewsCarboFix Orthopedics, Ltd. · 2019
- 2 generations backK200596 G21 Cement, VADER® Pedicle SystemIcotec AG · 2020 · Recalled
- 1 generation backK231280 CarboClear® X Pedicle Screw System; CarboClear® X Navigated…CarboFix Orthopedics, Ltd. · 2023
- This deviceK233944 CarboClear® X Pedicle Screw System; CarboClear® X Navigated…CarboFix Orthopedics, Ltd. · 2024
Class I recalls in this family
Most influential descendants
Showing 3 of 3 · See all- K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd. · 2024 · cites it directly2descendants
- K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd. · 2024 · cites it directly1descendant
- K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd. · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −22 | K040583 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −21 | K041118 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −20 | K042025 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2004 | 4 |
| −19 | K043151 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −18 | K050809 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2005 | — |
| −17 | K052187 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −16 | K053101 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −15 | K091442 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2009 | — |
| −14 | K091974 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2009 | 1 |
| −13 | K102555 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2010 | — |
| −12 | K112473 | CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2011 | — |
| −11 | K113174 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2011 | 1 |
| −10 | K121680 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2012 | — |
| −9 | K131321 | CD Horizon Spinal System | Medtronic Sofamor Danek USA | 2013 | — |
| −8 | K132111 | CD Horizon Spinal System | Medtronic Sofamor Danek USA | 2013 | — |
| −7 | K141604 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2014 | — |
| −6 | K143684 | NuVasive Reline System | Nu Vasive, Incorporated | 2015 | — |
| −5 | K160989 | NuVasive® Reline® System | Nu Vasive, Incorporated | 2016 | — |
| −4 | K180498 | NuVasive Reline Fenestrated Screws, High V+ Bone Cement | Nu Vasive, Incorporated | 2018 | — |
| −3 | K190526 | High V+ Bone Cement, CarboClear® Fenestrated Pedicle Screws | CarboFix Orthopedics, Ltd. | 2019 | — |
| −2 | K200596 | G21 Cement, VADER® Pedicle System | Icotec AG | 2020 | 1 |
| −1 | K231280 | CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments… | CarboFix Orthopedics, Ltd. | 2023 | — |
| 0 (this device) | 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 | K233793 | CarboClear® X Pedicle Screw System | CarboFix Orthopedics, Ltd. | 2024 | — |
| +2 | K243106 | CarboClear® Hybrid Pedicle Screw System | CarboFix Orthopedics, Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1984 | 3 | 0 |
| 1985 | 2 | 0 |
| 1986 | 2 | 0 |
| 1987 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 1 | 0 |
| 1990 | 4 | 0 |
| 1992 | 7 | 0 |
| 1993 | 4 | 0 |
| 1994 | 7 | 0 |
| 1995 | 17 | 0 |
| 1996 | 12 | 0 |
| 1997 | 14 | 0 |
| 1998 | 23 | 0 |
| 1999 | 24 | 0 |
| 2000 | 32 | 0 |
| 2001 | 45 | 0 |
| 2002 | 31 | 0 |
| 2003 | 33 | 0 |
| 2004 | 47 | 0 |
| 2005 | 41 | 0 |
| 2006 | 33 | 0 |
| 2007 | 29 | 1 |
| 2008 | 33 | 0 |
| 2009 | 26 | 0 |
| 2010 | 28 | 1 |
| 2011 | 29 | 0 |
| 2012 | 18 | 0 |
| 2013 | 17 | 0 |
| 2014 | 15 | 0 |
| 2015 | 8 | 0 |
| 2016 | 7 | 0 |
| 2017 | 5 | 0 |
| 2018 | 5 | 0 |
| 2019 | 2 | 0 |
| 2020 | 5 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 3 | 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.
2 devices in this family have 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 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? (7)
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 |
|---|---|---|---|
| * | K232341 | CarboClear® Pedicle Screw SystemSummary page 5…ARBOFIX ORTHOPEDICS LTD. CARBOCLEAR® X PEDICLE SCREW SYSTEM Predicate Devices Primary Predicate Device: • CarboClear® Pedicle Screw System (CarboFix Orthopedics Ltd.; K232341) Additional Predicate Devices: ▪ CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments (CarboFix Orthoped… | 2023 |
| * | K210716 | CarboClear X Pedicle Screw System, CarboClear X Navigated InstrumentsSummary page 5…oFix Orthopedics Ltd.; K232341) Additional Predicate Devices: ▪ CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments (CarboFix Orthopedics Ltd.; K210716, K231280) ▪ CarboClear® Pedicle Screw System (CarboFix Orthopedics Ltd.; K173487, K201926 and more) • CD HORIZON® Spinal Sy… | 2021 |
| * | K231280 | CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…Summary page 5…opedics Ltd.; K232341) Additional Predicate Devices: ▪ CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments (CarboFix Orthopedics Ltd.; K210716, K231280) ▪ CarboClear® Pedicle Screw System (CarboFix Orthopedics Ltd.; K173487, K201926 and more) • CD HORIZON® Spinal System (Med… | 2023 |
| * | K173487 | CarboClear® Pedicle Screw SystemSummary page 5…dicle Screw System; CarboClear® X Navigated Instruments (CarboFix Orthopedics Ltd.; K210716, K231280) ▪ CarboClear® Pedicle Screw System (CarboFix Orthopedics Ltd.; K173487, K201926 and more) • CD HORIZON® Spinal System (Medtronic Sofamor Danek; K082236 and more) • S4® Spinal System (Aesculap Sp… | 2018 |
| * | K201926 | CarboClear® Pedicle Screw System, CarboClear® II Pedicle Screw SystemSummary page 5…ystem; CarboClear® X Navigated Instruments (CarboFix Orthopedics Ltd.; K210716, K231280) ▪ CarboClear® Pedicle Screw System (CarboFix Orthopedics Ltd.; K173487, K201926 and more) • CD HORIZON® Spinal System (Medtronic Sofamor Danek; K082236 and more) • S4® Spinal System (Aesculap Spine; K130291… | 2020 |
| * | K082236 | CD Horizon Spinal SystemSummary page 5…; K210716, K231280) ▪ CarboClear® Pedicle Screw System (CarboFix Orthopedics Ltd.; K173487, K201926 and more) • CD HORIZON® Spinal System (Medtronic Sofamor Danek; K082236 and more) • S4® Spinal System (Aesculap Spine; K130291 and more) Intended Use/Indications for Use CarboClear® X Pedicle Screw… | 2008 |
| * | K130291 | S4 Spinal SystemSummary page 5…(CarboFix Orthopedics Ltd.; K173487, K201926 and more) • CD HORIZON® Spinal System (Medtronic Sofamor Danek; K082236 and more) • S4® Spinal System (Aesculap Spine; K130291 and more) Intended Use/Indications for Use CarboClear® X Pedicle Screw System The CarboClear® X Pedicle Screw System is intend… | 2013 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (2 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.
What does this lineage say?
- The line of descent spans 20 years and passes through 7 companies; a new generation was cleared every 7 months on median.
- 74 of the 637 ancestors have a recall of any class; 2 have a Class I recall.
- Of its descendants, K240846 (CarboFix Orthopedics, Ltd., 2024) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K232341.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 provide rigid immobilization and stabilization of lumbar and/or sacral segments as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level from L2 to S1, with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Patients should be skeletally mature and have at least six…
Read the full statement (205 words)
The CarboClear@ X Pedicle Screw System is intended to provide rigid immobilization and stabilization of lumbar and/or sacral segments as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level from L2 to S1, with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Patients should be skeletally mature and have at least six months of non-operative treatment.
The CarboClear@ X Pedicle Screw System is intended to be used with an intervertebral body fusion device implanted at the same spinal level with autogenous and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft.
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/K233944 · printed Nov 5, 2026
Cite this page
510(k) Report. “K233944: 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/K233944
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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