510(k) · Cleared
ClearedCarboClear® 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 Oct 10, 2023 as substantially equivalent to K181119 (K2m, Inc., 2018) and 5 other predicates after a 67-day review. Its family tree reaches back 20 generations to 1985. 4 later devices descend from it.
- Decided
- Oct 10, 2023
- Review
- 67 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 20 generations to K853033 (1985). 471 ancestors in all, the oldest K781443 (1978). 4 later devices descend from it, 2 citing it directly.
- Root · 20 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 16 generations between
- 3 generations backK141873 Range/Mesa/Denali Spinal SystemK2m, Inc. · 2014
- 2 generations backK171832 Range/Denali/Mesa Spinal SystemK2m, Inc. · 2017
- 1 generation backK181119 Range (Denali and Mesa) Spinal SystemsK2m, Inc. · 2018
- This deviceK232341 CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd. · 2023
- Descendant · cites it directly · 3 of its ownK233944 CarboClear® X Pedicle Screw System; CarboClear® X Navigated…CarboFix Orthopedics, Ltd. · 2024
- Descendant · 2 generations on · 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 20 generations
- Root · 20 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 19 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
- 18 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
- 17 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
- 16 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
- 15 generations backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
- 14 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
- 13 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
- 12 generations backK062174 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 11 generations backK063156 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 10 generations backK063741 Expedium Spine SystemDepuy Spine, Inc. · 2007
- 9 generations backK080313 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2008
- 8 generations backK111571 Viper SystemsJohnson & Johnson · 2011
- 7 generations backK121016 Range Spinal System (Mesa and Denali)K2m, Inc. · 2012
- 6 generations backK130330 Range Spinal SystemK2m, Inc. · 2013
- 5 generations backK131784 Range Spinal SystemK2m, Inc. · 2013
- 4 generations backK133944 Range, Spinal System, Everest Spinal SystemK2m, Inc. · 2014
- 3 generations backK141873 Range/Mesa/Denali Spinal SystemK2m, Inc. · 2014
- 2 generations backK171832 Range/Denali/Mesa Spinal SystemK2m, Inc. · 2017
- 1 generation backK181119 Range (Denali and Mesa) Spinal SystemsK2m, Inc. · 2018
- This deviceK232341 CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd. · 2023
Most influential descendants
Showing 4 of 4 · See all- 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 · 2 generations on2descendants
- 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 |
|---|---|---|---|---|---|
| −20 | K853033 | Hartshill Rect & Wires, Spinal Fixation System | A.W. Showell (Surgicraft), Ltd. | 1985 | — |
| −19 | K965221 | Ransford Cervical Fixation System | Surgicraft, Ltd. | 1997 | — |
| −18 | K982322 | Synthes Spine Occipital-Cervical Plate/Rod and Hook System | Synthes (Usa) | 1998 | — |
| −17 | K002733 | Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2000 | — |
| −16 | K013222 | Summit Occipito-Cervico- Thoracic (Oct) Spinal System | Depuyacromed | 2001 | — |
| −15 | K022190 | Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2002 | — |
| −14 | K030103 | Summit Oct Spinal System Minipolyaxial Screws | Depuyacromed | 2003 | — |
| −13 | K041203 | Summit Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
| −12 | K062174 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| −11 | K063156 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| −10 | K063741 | Expedium Spine System | Depuy Spine, Inc. | 2007 | — |
| −9 | K080313 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2008 | — |
| −8 | K111571 | Viper Systems | Johnson & Johnson | 2011 | — |
| −7 | K121016 | Range Spinal System (Mesa and Denali) | K2m, Inc. | 2012 | — |
| −6 | K130330 | Range Spinal System | K2m, Inc. | 2013 | — |
| −5 | K131784 | Range Spinal System | K2m, Inc. | 2013 | — |
| −4 | K133944 | Range, Spinal System, Everest Spinal System | K2m, Inc. | 2014 | — |
| −3 | K141873 | Range/Mesa/Denali Spinal System | K2m, Inc. | 2014 | — |
| −2 | K171832 | Range/Denali/Mesa Spinal System | K2m, Inc. | 2017 | — |
| −1 | K181119 | Range (Denali and Mesa) Spinal Systems | K2m, Inc. | 2018 | — |
| 0 (this device) | K232341 | CarboClear® Pedicle Screw System | CarboFix Orthopedics, Ltd. | 2023 | — |
| +1 | K233944 | CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments | CarboFix Orthopedics, Ltd. | 2024 | — |
| +2 | 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 | 1 | 0 |
| 1990 | 3 | 0 |
| 1992 | 5 | 0 |
| 1993 | 4 | 0 |
| 1994 | 3 | 0 |
| 1995 | 10 | 0 |
| 1996 | 10 | 0 |
| 1997 | 7 | 0 |
| 1998 | 17 | 0 |
| 1999 | 19 | 0 |
| 2000 | 21 | 0 |
| 2001 | 36 | 0 |
| 2002 | 26 | 0 |
| 2003 | 27 | 0 |
| 2004 | 43 | 0 |
| 2005 | 36 | 0 |
| 2006 | 26 | 0 |
| 2007 | 23 | 0 |
| 2008 | 27 | 0 |
| 2009 | 23 | 0 |
| 2010 | 19 | 0 |
| 2011 | 22 | 0 |
| 2012 | 14 | 0 |
| 2013 | 11 | 0 |
| 2014 | 6 | 0 |
| 2015 | 3 | 0 |
| 2016 | 4 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 4 | 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? (6)
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 |
|---|---|---|---|
| * | K181119 | Range (Denali and Mesa) Spinal SystemsSummary page 5…3 CarboFix Orthopedics Ltd. CarboClear® Pedicle Screw System - DDD Predicate Devices Primary Predicates: ƒ Mesa Spinal System (K2M, Inc.; K181119 and more) Additional Predicates: ƒ CarboClear Pedicle Screw System, (CarboFix Orthopedics Ltd., K173487 and more). ƒ… | 2018 |
| * | K173487 | CarboClear® Pedicle Screw SystemSummary page 5…es Primary Predicates: ƒ Mesa Spinal System (K2M, Inc.; K181119 and more) Additional Predicates: ƒ CarboClear Pedicle Screw System, (CarboFix Orthopedics Ltd., K173487 and more). ƒ CD HORIZON® Spinal System (Medtronic Sofamor Danek; K0822236 and more) ƒ Synergy VLS Spinal System (In… | 2018 |
| * | K082236 | CD Horizon Spinal System | 2008 |
| * | K010515 | Modification to Synergy Spinal SystemSummary page 5…d., K173487 and more). ƒ CD HORIZON® Spinal System (Medtronic Sofamor Danek; K0822236 and more) ƒ Synergy VLS Spinal System (Interpore Cross International; K010515 and more) ƒ S4® Spinal System (Aesculap Spine; K130291 and more) ƒ REVERE® Stabilization System (Globus Medical, Inc.; K1… | 2001 |
| * | K130291 | S4 Spinal SystemSummary page 5…m (Medtronic Sofamor Danek; K0822236 and more) ƒ Synergy VLS Spinal System (Interpore Cross International; K010515 and more) ƒ S4® Spinal System (Aesculap Spine; K130291 and more) ƒ REVERE® Stabilization System (Globus Medical, Inc.; K133350 and more) Indications for Use The CarboClear® Pedic… | 2013 |
| * | K133350 | Revere Stabilization SystemSummary page 5…em (Interpore Cross International; K010515 and more) ƒ S4® Spinal System (Aesculap Spine; K130291 and more) ƒ REVERE® Stabilization System (Globus Medical, Inc.; K133350 and more) Indications for Use The CarboClear® Pedicle Screw System is intended to provide rigid immobilization and stabilizatio… | 2014 |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 38 years and passes through 8 companies; a new generation was cleared every 12 months on median.
- 48 of the 471 ancestors have a recall of any class.
- Of its descendants, K233944 (CarboFix Orthopedics, Ltd., 2024) has gone furthest, with 3 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. 2023, 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 ® 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 (115 words)
The CarboClear ® 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 ® 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.
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/K232341 · printed Nov 5, 2026
Cite this page
510(k) Report. “K232341: CarboClear® Pedicle 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/K232341
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