510(k) · Cleared
ClearedCarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
CarboFix Orthopedics, Ltd. · NKG Posterior Cervical Screw System
Cleared on Mar 16, 2026 as substantially equivalent to K252327 (Icotec AG, 2025) and 2 other predicates after an 89-day review. Its family tree reaches back 23 generations to 2004. 10 of the 866 devices in its family, counting itself, have a Class I recall.
- Decided
- Mar 16, 2026
- Review
- 89 days
- Class
- Class II
- Product code
- NKG
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 23 generations to K040583 (2004). 865 ancestors in all, the oldest K781443 (1978). No later device cites it as a predicate yet. 10 of the 866 devices in this family, counting this one, have a Class I recall.
- Root · 23 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 19 generations between
- 3 generations backK200047 ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc. · 2020 · Recalled
- 2 generations backK231850 QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS®…Globus Medical, Inc. · 2024
- 1 generation backK252327 CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG · 2025
- This deviceK254045 CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid…CarboFix Orthopedics, Ltd. · 2026
Show all 23 generations
- Root · 23 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 22 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 21 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
- 20 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 19 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
- 18 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 17 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
- 16 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
- 15 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
- 14 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
- 13 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
- 12 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
- 11 generations backK121680 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
- 10 generations backK122862 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
- 9 generations backK141605 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2014
- 8 generations backK143375 CD HORIZON Spinal System, Medtronic Navigated Reusable InstrumentsMedtronic Sofamor Danek USA, Inc. · 2015
- 7 generations backK153203 Navigation InstrumentsGlobus Medical, Inc. · 2016
- 6 generations backK161591 QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation…Globus Medical, Inc. · 2016
- 5 generations backK171651 Excelsius GPSGlobus Medical, Inc. · 2017 · Recalled
- 4 generations backK191100 ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc. · 2019
- 3 generations backK200047 ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc. · 2020 · Recalled
- 2 generations backK231850 QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS®…Globus Medical, Inc. · 2024
- 1 generation backK252327 CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG · 2025
- This deviceK254045 CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid…CarboFix Orthopedics, Ltd. · 2026
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −23 | K040583 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −22 | K041118 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −21 | K042025 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2004 | 4 |
| −20 | K043151 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −19 | K050809 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2005 | — |
| −18 | K052187 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −17 | K053101 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −16 | K091442 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2009 | — |
| −15 | K091974 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2009 | 1 |
| −14 | K102555 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2010 | — |
| −13 | K112473 | CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2011 | — |
| −12 | K113174 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2011 | 1 |
| −11 | K121680 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2012 | — |
| −10 | K122862 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2012 | — |
| −9 | K141605 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2014 | — |
| −8 | K143375 | CD HORIZON Spinal System, Medtronic Navigated Reusable Instruments | Medtronic Sofamor Danek USA, Inc. | 2015 | — |
| −7 | K153203 | Navigation Instruments | Globus Medical, Inc. | 2016 | — |
| −6 | K161591 | QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments | Globus Medical, Inc. | 2016 | — |
| −5 | K171651 | Excelsius GPS | Globus Medical, Inc. | 2017 | 1 |
| −4 | K191100 | ExcelsiusGPS Spine 1.1 Interbody Module | Globus Medical, Inc. | 2019 | — |
| −3 | K200047 | ExcelsiusGPS Cranial 1.0 Module | Globus Medical, Inc. | 2020 | 3 |
| −2 | K231850 | QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® Instruments | Globus Medical, Inc. | 2024 | — |
| −1 | K252327 | CMORE® CT System; CMORE® CT System Navigated Instruments | Icotec AG | 2025 | — |
| 0 (this device) | K254045 | CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior… | CarboFix Orthopedics, Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1979 | 2 | 0 |
| 1980 | 1 | 0 |
| 1981 | 2 | 0 |
| 1984 | 2 | 0 |
| 1985 | 2 | 0 |
| 1986 | 2 | 0 |
| 1987 | 3 | 0 |
| 1988 | 2 | 0 |
| 1989 | 5 | 0 |
| 1990 | 4 | 0 |
| 1991 | 1 | 0 |
| 1992 | 8 | 0 |
| 1993 | 6 | 0 |
| 1994 | 9 | 0 |
| 1995 | 18 | 0 |
| 1996 | 19 | 0 |
| 1997 | 15 | 0 |
| 1998 | 24 | 0 |
| 1999 | 26 | 0 |
| 2000 | 31 | 0 |
| 2001 | 48 | 1 |
| 2002 | 41 | 0 |
| 2003 | 46 | 0 |
| 2004 | 70 | 0 |
| 2005 | 60 | 0 |
| 2006 | 45 | 0 |
| 2007 | 38 | 0 |
| 2008 | 72 | 0 |
| 2009 | 41 | 0 |
| 2010 | 40 | 2 |
| 2011 | 36 | 0 |
| 2012 | 19 | 0 |
| 2013 | 25 | 0 |
| 2014 | 16 | 0 |
| 2015 | 25 | 2 |
| 2016 | 10 | 1 |
| 2017 | 8 | 1 |
| 2018 | 5 | 1 |
| 2019 | 3 | 1 |
| 2020 | 5 | 0 |
| 2021 | 4 | 1 |
| 2024 | 2 | 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.
10 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 NKG device
- #1 K252327 CMORE® CT System; CMORE® CT System Navigated…score 19.6 · 22 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 |
|---|---|---|---|
| * | K252327 | CMORE® CT System; CMORE® CT System Navigated InstrumentsSummary page 6…lear® Posterior Cervical Screw System CarboClear® Hybrid Posterior Cervical Screw System Predicate Devices Primary Predicate Device: CMORE® CT System (icotec; K252327) Additional Predicate Devices: CarboClear® Posterior Cervical Screw System (CarboFix Orthopedics Ltd.;K233989) … | 2025 |
| * | K233989 | CarboClear® Posterior Cervical Screw SystemSummary page 6…dicate Device: CMORE® CT System (icotec; K252327) Additional Predicate Devices: CarboClear® Posterior Cervical Screw System (CarboFix Orthopedics Ltd.;K233989) INFINITY™ OCT System (Medtronic; K163375) Reference Device: CarboClear® Hybrid Pedicle Screw System (CarboFix O… | 2024 |
| * | K163375 | INFINITY™ OCT SystemSummary page 6…252327) Additional Predicate Devices: CarboClear® Posterior Cervical Screw System (CarboFix Orthopedics Ltd.;K233989) INFINITY™ OCT System (Medtronic; K163375) Reference Device: CarboClear® Hybrid Pedicle Screw System (CarboFix Orthopedics Ltd.; K240846, K243106) Indi… | 2017 |
| † | K240846 | CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments… | 2024 |
| † | K243106 | CarboClear® Hybrid Pedicle Screw System | 2024 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (10 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.
- K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 3 generations back · ◆ in the 2021 ancestors bar of FIG. 11 Class I recall
- K182417ROSA ONE Brain ApplicationMedtech S.A · 2019 · 4 generations back · ◆ in the 2019 ancestors bar of FIG. 11 Class I recall
- K162309StealthStation S8 System Platforms and StealthStation Cranial SoftwareMedtronic Navigation, Inc. · 2017 · 4 generations back · ◆ in the 2017 ancestors bar of FIG. 12 Class I recalls
- K172444ROSA BRAIN (v3.0.0.5)Medtech S.A · 2018 · 5 generations back · ◆ in the 2018 ancestors bar of FIG. 11 Class I recall
- K153660StealthStation System with Cranial SoftwareMedtronic Navigation, Inc. · 2016 · 5 generations back · ◆ in the 2016 ancestors bar of FIG. 13 Class I recalls
- K151359ROSA BrainMedtech S.A · 2015 · 6 generations back · ◆ in the 2015 ancestors bar of FIG. 11 Class I recall
- K150216Synergy CranialMedtronic Navigation, Inc. · 2015 · 6 generations back · ◆ in the 2015 ancestors bar of FIG. 13 Class I recalls
- K100952Modification to Synthes Matrix SystemSynthes Spine · 2010 · 6 generations back · ◆ in the 2010 ancestors bar of FIG. 11 Class I recall
- K093670Modification to: Oasys SystemStryker Spine · 2010 · 7 generations back · ◆ in the 2010 ancestors bar of FIG. 11 Class I recall
- K003837Flexiview 8800 Digital Mobile Imaging SystemGe Oec Medical Systems · 2001 · 8 generations back · ◆ in the 2001 ancestors bar of FIG. 11 Class I recall
Nearest 5 of 10; all are on the web page.
What does this lineage say?
- The line of descent spans 22 years and passes through 6 companies; a new generation was cleared every 7 months on median.
- 113 of the 865 ancestors have a recall of any class; 10 have a Class I recall.
How does its category compare?
All NKG devicesNKG Posterior Cervical Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · NKG
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NKG
58in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NKG
2in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NKG
153in 2025
MAUDE reports naming product code NKG, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 17 | 71 | 0 | 4 |
| 2016 | 16 | 87 | 0 | 73 |
| 2017 | 15 | 108 | 0 | 99 |
| 2018 | 12 | 61 | 1 | 127 |
| 2019 | 8 | 50 | 1 | 214 |
| 2020 | 14 | 59 | 2 | 236 |
| 2021 | 7 | 56 | 0 | 704 |
| 2022 | 7 | 108 | 0 | 175 |
| 2023 | 10 | 58 | 0 | 131 |
| 2024 | 3 | 100 | 0 | 206 |
| 2025 | 6 | 58 | 0 | 153 |
| 2026 | 4 | 169 | 0 | — |
What is it indicated for?
The CarboClear® Posterior Cervical Screw System / CarboClear® Hybrid Posterior Cervical 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 cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion. The CarboClear® Posterior Cervical Screw System / CarboClear® Hybrid Posterior Cervical…
Read the full statement (219 words)
The CarboClear® Posterior Cervical Screw System / CarboClear® Hybrid Posterior Cervical 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 cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
The CarboClear® Posterior Cervical Screw System / CarboClear® Hybrid Posterior Cervical Screw System is intended to provide immobilization and stabilization of spinal segments with anterior interbody support implanted at the same spinal level/s as an adjunct to fusion for the following acute and chronic instabilities of the cervical spine and the upper thoracic spine (T1 to T3):
- Traumatic spinal fractures and/or dislocations
- Instability and deformity
- Failed previous fusions (e.g., pseudarthrosis)
- Degenerative disease, including intractable radiculopathy and/or myelopathy
- Neck and/or arm pain of discogenic origin as confirmed by radiographic studies
- Degenerative disease of the facets with instability
- Patients with spinal infection (e.g., spondylodiscitis, osteomyelitis) and spinal instability due to infection, surgical debridement, or decompression
The CarboClear® Posterior Cervical Screw System / CarboClear® Hybrid Posterior Cervical Screw System is intended to be used with anterior interbody support implanted at the same spinal level/s with autogenous and /or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K254045 · printed Nov 6, 2026
Cite this page
510(k) Report. “K254045: CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical 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/K254045
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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