510(k) · Cleared
ClearedCarboClear® 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 27, 2024 as substantially equivalent to K142838 (Synthes USA Products, LLC, 2015) and 2 other predicates after a 100-day review. Its family tree reaches back 21 generations to 2004. 1 of the 458 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it.
- Decided
- Mar 27, 2024
- Review
- 100 days
- Class
- Class II
- Product code
- NKG
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 21 generations to K040583 (2004). 455 ancestors in all, the oldest K781443 (1978). 2 later devices descend from it, 2 citing it directly. 1 of the 458 devices in this family, counting this one, has a Class I recall.
- Root · 21 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 17 generations between
- 3 generations backK201926 CarboClear® Pedicle Screw System, CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd. · 2020
- 2 generations backK203317 CarboClear X Pedicle Screw SystemCarboFix Orthopedics, Ltd. · 2020
- 1 generation backK210716 CarboClear X Pedicle Screw System, CarboClear X Navigated InstrumentsCarboFix Orthopedics, Ltd. · 2021
- This deviceK233989 CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd. · 2024
- Descendant · cites it directly · 1 of its ownK252327 CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG · 2025
- Descendant · cites it directly · 0 of its ownK254045 CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid…CarboFix Orthopedics, Ltd. · 2026
Show all 21 generations
- Root · 21 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 20 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 19 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
- 18 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 17 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
- 16 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 15 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
- 14 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
- 13 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
- 12 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
- 11 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
- 10 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
- 9 generations backK152604 KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw SetMedtronic Sofamor Danek USA, Incorporated · 2016
- 8 generations backK160879 CONFIDENCE™ High Viscosity Spinal Cement, VIPER® and EXPEDIUM®…Medos International Sàrl · 2016
- 7 generations backK170543 VIPER PRIME™ Screws with FenestrationsMedos International SARL · 2017
- 6 generations backK173487 CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd. · 2018
- 5 generations backK182377 CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd. · 2018
- 4 generations backK200519 CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd. · 2020
- 3 generations backK201926 CarboClear® Pedicle Screw System, CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd. · 2020
- 2 generations backK203317 CarboClear X Pedicle Screw SystemCarboFix Orthopedics, Ltd. · 2020
- 1 generation backK210716 CarboClear X Pedicle Screw System, CarboClear X Navigated InstrumentsCarboFix Orthopedics, Ltd. · 2021
- This deviceK233989 CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd. · 2024
Class I recalls in this family
- K093670 Modification to: Oasys System6 generations back · 2010
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −21 | K040583 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −20 | K041118 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −19 | K042025 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2004 | 4 |
| −18 | K043151 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −17 | K050809 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2005 | — |
| −16 | K052187 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −15 | K053101 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −14 | K091442 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2009 | — |
| −13 | K091974 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2009 | 1 |
| −12 | K102555 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2010 | — |
| −11 | K112473 | CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2011 | — |
| −10 | K113174 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2011 | 1 |
| −9 | K152604 | KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw Set | Medtronic Sofamor Danek USA, Incorporated | 2016 | — |
| −8 | K160879 | CONFIDENCE™ High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated… | Medos International Sàrl | 2016 | — |
| −7 | K170543 | VIPER PRIME™ Screws with Fenestrations | Medos International SARL | 2017 | — |
| −6 | K173487 | CarboClear® Pedicle Screw System | CarboFix Orthopedics, Ltd. | 2018 | — |
| −5 | K182377 | CarboClear® Pedicle Screw System | CarboFix Orthopedics, Ltd. | 2018 | — |
| −4 | K200519 | CarboClear® II Pedicle Screw System | CarboFix Orthopedics, Ltd. | 2020 | — |
| −3 | 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 | — |
| −1 | K210716 | CarboClear X Pedicle Screw System, CarboClear X Navigated Instruments | CarboFix Orthopedics, Ltd. | 2021 | — |
| 0 (this device) | K233989 | CarboClear® Posterior Cervical Screw System | CarboFix Orthopedics, Ltd. | 2024 | — |
| +1 | K252327 | CMORE® CT System; CMORE® CT System Navigated Instruments | Icotec AG | 2025 | — |
| +1 | 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 |
| 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 | 4 | 0 |
| 1994 | 7 | 0 |
| 1995 | 14 | 0 |
| 1996 | 11 | 0 |
| 1997 | 14 | 0 |
| 1998 | 18 | 0 |
| 1999 | 19 | 0 |
| 2000 | 21 | 0 |
| 2001 | 32 | 0 |
| 2002 | 26 | 0 |
| 2003 | 25 | 0 |
| 2004 | 39 | 0 |
| 2005 | 31 | 0 |
| 2006 | 20 | 0 |
| 2007 | 18 | 0 |
| 2008 | 28 | 0 |
| 2009 | 13 | 0 |
| 2010 | 15 | 1 |
| 2011 | 12 | 0 |
| 2012 | 9 | 0 |
| 2013 | 7 | 0 |
| 2014 | 6 | 0 |
| 2015 | 15 | 0 |
| 2016 | 5 | 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 |
|---|---|---|
| 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.
1 device in this family has 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 |
|---|---|---|---|
| * | K142838 | Synapse Occipital-Cervical-Thoracic (OCT) SystemSummary page 5…pedics Ltd. CarboClear® Posterior Cervical Screw System Predicate Devices Primary Predicate: Synapse Occipital-Cervical-Thoracic (OCT) System (DePuy Synthes Spine; K142838) Additional Predicates: Mesa Mini Spinal System (K2M, Inc.; K153370) CarboClear® X Pedicle Screw System (CarboFix Orth… | 2015 |
| * | K153370 | Caspian OCT/MESA Mini/DENALI Mini Spinal SystemSummary page 5…Primary Predicate: Synapse Occipital-Cervical-Thoracic (OCT) System (DePuy Synthes Spine; K142838) Additional Predicates: Mesa Mini Spinal System (K2M, Inc.; K153370) CarboClear® X Pedicle Screw System (CarboFix Orthopedics Ltd.; K210716) Reference: CarboClear® Cervical Cage and VBR… | 2016 |
| * | K210716 | CarboClear X Pedicle Screw System, CarboClear X Navigated InstrumentsSummary page 5…Puy Synthes Spine; K142838) Additional Predicates: Mesa Mini Spinal System (K2M, Inc.; K153370) CarboClear® X Pedicle Screw System (CarboFix Orthopedics Ltd.; K210716) Reference: CarboClear® Cervical Cage and VBR System (CarboFix Orthopedics Ltd.; K222874) Indications for Use The Carb… | 2021 |
| † | K222874 | CarboClear Cervical Cage System, CarboClear Cervical VBR System | 2023 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 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.
- K093670Modification to: Oasys SystemStryker Spine · 2010 · 6 generations back · ◆ in the 2010 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 20 years and passes through 7 companies; a new generation was cleared every 4 months on median.
- 47 of the 455 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K252327 (Icotec AG, 2025) has gone furthest, with 1 descendant of its own.
- 31 other devices also cite its predicate K142838.
How does its category compare?
All NKG devicesNKG Posterior Cervical 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 · 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 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233989 · printed Nov 5, 2026
Cite this page
510(k) Report. “K233989: CarboClear® Posterior Cervical Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K233989
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