510(k) Report

510(k) · Cleared

Cleared

CarboClear® Hybrid Pedicle Screw System

K243106510(k) TraditionalCleared Nov 5, 202436-day reviewClass II21 CFR 888.3070

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

CarboFix Orthopedics, Ltd. · NKB Thoracolumbosacral Pedicle Screw System

Cleared on Nov 5, 2024 as substantially equivalent to K233793 (CarboFix Orthopedics, Ltd., 2024) and 4 other predicates after a 36-day review. Its family tree reaches back 25 generations to 2004. 2 of the 660 devices in its family, counting itself, have a Class I recall.

Decided
Nov 5, 2024
Review
36 days
Class
Class II
Product code
NKB
Recalls
None
Predicates
5

Its longest line of descent runs back 25 generations to K040583 (2004). 659 ancestors in all, the oldest K781443 (1978). No later device cites it as a predicate yet. 2 of the 660 devices in this family, counting this one, have a Class I recall.

Other ancestors, by year cleared 2020: 6 other ancestors2013: 17 other ancestors2008: 33 other ancestors2023: 2 other ancestors2021: 1 other ancestor2019: 2 other ancestors2017: 6 other ancestors2016: 7 other ancestors2015: 9 other ancestors2012: 21 other ancestors2011: 31 other ancestors2007: 30 other ancestors, 1 with a Class I recall12006: 33 other ancestors2005: 42 other ancestors2004: 48 other ancestors2003: 34 other ancestors2018: 5 other ancestors2014: 15 other ancestors2010: 29 other ancestors, 1 with a Class I recall12002: 33 other ancestors2001: 45 other ancestors2000: 33 other ancestors1999: 24 other ancestors1998: 24 other ancestors1997: 14 other ancestors2009: 26 other ancestors1996: 13 other ancestors1995: 17 other ancestors1984: 3 other ancestors1994: 7 other ancestors1993: 4 other ancestors1992: 7 other ancestors1990: 4 other ancestors1988: 2 other ancestors1987: 1 other ancestor1978: 1 other ancestor1989: 1 other ancestor1986: 2 other ancestors1985: 2 other ancestors×7: 7 generations cleared close together, K040583 (2004), K041118 (2004), K042025 (2004), K043151 (2005), K050809 (2005), K052187 (2005), K053101 (2006) ×2: 2 generations cleared close together, K091442 (2009), K091974 (2009) K102555 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2010×2: 2 generations cleared close together, K112473 (2011), K113174 (2011) K121680 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2012×2: 2 generations cleared close together, K131321 (2013), K132111 (2013) ×2: 2 generations cleared close together, K141604 (2014), K143684 (2015) K160989 · NuVasive® Reline® System · Nu Vasive, Incorporated · 2016K180498 · NuVasive Reline Fenestrated Screws, High V+ Bone Cement · Nu Vasive, Incorporated · 2018K190526 · High V+ Bone Cement, CarboClear® Fenestrated Pedicle Screws · CarboFix Orthopedics, Ltd. · 2019K200596 · G21 Cement, VADER® Pedicle System · Icotec AG · 2020 · recalled×4: 4 generations cleared close together, K231280 (2023), K233944 (2024), K240846 (2024), K233793 (2024) 19801990200020102020
Other ancestors, by generation 1 generation back: 3 other ancestors2 generations back: 22 other ancestors3 generations back: 52 other ancestors4 generations back: 93 other ancestors5 generations back: 125 other ancestors, 2 with a Class I recall26 generations back: 132 other ancestors7 generations back: 75 other ancestors8 generations back: 70 other ancestors9 generations back: 36 other ancestors10 generations back: 19 other ancestors11 generations back: 6 other ancestors12 generations back: 1 other ancestor K233793 · CarboClear® X Pedicle Screw System · CarboFix Orthopedics, Ltd. · 2024K240846 · CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments; CarboClear® Hybrid Fenestrated Pedicle Screw System and High V+® Bone Cement; CarboClear® X Fenestrated Pedicle Screw System and High V+® Bone Cement · CarboFix Orthopedics, Ltd. · 2024K233944 · CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments · CarboFix Orthopedics, Ltd. · 2024K231280 · CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X Fenestrated Pedicle Screw System with High V+® Bone Cement · CarboFix Orthopedics, Ltd. · 2023K200596 · G21 Cement, VADER® Pedicle System · Icotec AG · 2020 · recalledK190526 · High V+ Bone Cement, CarboClear® Fenestrated Pedicle Screws · CarboFix Orthopedics, Ltd. · 2019K180498 · NuVasive Reline Fenestrated Screws, High V+ Bone Cement · Nu Vasive, Incorporated · 2018K160989 · NuVasive® Reline® System · Nu Vasive, Incorporated · 2016K143684 · NuVasive Reline System · Nu Vasive, Incorporated · 2015K141604 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2014K132111 · CD Horizon Spinal System · Medtronic Sofamor Danek USA · 2013K131321 · CD Horizon Spinal System · Medtronic Sofamor Danek USA · 2013K121680 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2012K113174 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2011 · recalledK112473 · CD Horizon Spinal System · Medtronic Sofamor Danek, Inc. · 2011K102555 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2010K091974 · Modification to CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2009 · recalledK091442 · CD Horizon Spinal System · Medtronic Sofamor Danek · 2009K053101 · CD Horizon Spinal System · Medtronic Sofamor Danek · 2006K052187 · Modification to: CD Horizon Spinal System · Medtronic Sofamor Danek · 2005K050809 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2005K043151 · Modification to: CD Horizon Spinal System · Medtronic Sofamor Danek · 2005K042025 · Modification to CD Horizon Spinal System · Medtronic Sofamor Danek, Inc. · 2004 · recalledK041118 · Modification to CD Horizon Spinal System · Medtronic Sofamor Danek · 2004K040583 · Modification to: CD Horizon Spinal System · Medtronic Sofamor Danek · 2004−25−20−15−10−50
  1. Root · 25 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  2. 21 generations between
  3. 3 generations backK233944 CarboClear® X Pedicle Screw System; CarboClear® X Navigated…CarboFix Orthopedics, Ltd. · 2024
  4. 2 generations backK240846 CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid…CarboFix Orthopedics, Ltd. · 2024
  5. 1 generation backK233793 CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd. · 2024
  6. This deviceK243106 CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd. · 2024
Show all 25 generations
  1. Root · 25 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  2. 24 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  3. 23 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
  4. 22 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
  5. 21 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
  6. 20 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
  7. 19 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
  8. 18 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
  9. 17 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
  10. 16 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
  11. 15 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
  12. 14 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
  13. 13 generations backK121680 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
  14. 12 generations backK131321 CD Horizon Spinal SystemMedtronic Sofamor Danek USA · 2013
  15. 11 generations backK132111 CD Horizon Spinal SystemMedtronic Sofamor Danek USA · 2013
  16. 10 generations backK141604 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2014
  17. 9 generations backK143684 NuVasive Reline SystemNu Vasive, Incorporated · 2015
  18. 8 generations backK160989 NuVasive® Reline® SystemNu Vasive, Incorporated · 2016
  19. 7 generations backK180498 NuVasive Reline Fenestrated Screws, High V+ Bone CementNu Vasive, Incorporated · 2018
  20. 6 generations backK190526 High V+ Bone Cement, CarboClear® Fenestrated Pedicle ScrewsCarboFix Orthopedics, Ltd. · 2019
  21. 5 generations backK200596 G21 Cement, VADER® Pedicle SystemIcotec AG · 2020 · Recalled
  22. 4 generations backK231280 CarboClear® X Pedicle Screw System; CarboClear® X Navigated…CarboFix Orthopedics, Ltd. · 2023
  23. 3 generations backK233944 CarboClear® X Pedicle Screw System; CarboClear® X Navigated…CarboFix Orthopedics, Ltd. · 2024
  24. 2 generations backK240846 CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid…CarboFix Orthopedics, Ltd. · 2024
  25. 1 generation backK233793 CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd. · 2024
  26. This deviceK243106 CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd. · 2024

Class I recalls in this family

  • K100952 Modification to Synthes Matrix System5 generations back · 2010
  • K070106 VV Fluoro 3D5 generations back · 2007
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−25K040583Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2004—
−24K041118Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek2004—
−23K042025Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.20044
−22K043151Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005—
−21K050809CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2005—
−20K052187Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005—
−19K053101CD Horizon Spinal SystemMedtronic Sofamor Danek2006—
−18K091442CD Horizon Spinal SystemMedtronic Sofamor Danek2009—
−17K091974Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20091
−16K102555CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2010—
−15K112473CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2011—
−14K113174CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20111
−13K121680CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2012—
−12K131321CD Horizon Spinal SystemMedtronic Sofamor Danek USA2013—
−11K132111CD Horizon Spinal SystemMedtronic Sofamor Danek USA2013—
−10K141604CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2014—
−9K143684NuVasive Reline SystemNu Vasive, Incorporated2015—
−8K160989NuVasive® Reline® SystemNu Vasive, Incorporated2016—
−7K180498NuVasive Reline Fenestrated Screws, High V+ Bone CementNu Vasive, Incorporated2018—
−6K190526High V+ Bone Cement, CarboClear® Fenestrated Pedicle ScrewsCarboFix Orthopedics, Ltd.2019—
−5K200596G21 Cement, VADER® Pedicle SystemIcotec AG20201
−4K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments…CarboFix Orthopedics, Ltd.2023—
−3K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.2024—
−2K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated…CarboFix Orthopedics, Ltd.2024—
−1K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.2024—
0 (this device)K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.2024—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197810
198430
198520
198620
198710
198820
198910
199040
199270
199340
199470
1995170
1996130
1997140
1998240
1999240
2000330
2001450
2002330
2003340
2004480
2005420
2006330
2007301
2008330
2009260
2010291
2011310
2012210
2013170
2014150
201590
201670
201760
201850
201920
202060
202110
202320
FIG. 1 — Lineage of K243106, 2004–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K223494 CD Horizon Spinal Systemscore 40.4 · 30 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (5)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K233793CarboClear® X Pedicle Screw System
Summary page 6
…FIX ORTHOPEDICS LTD. CARBOCLEAR® HYBRID PEDICLE SCREW SYSTEM PREDICATE DEVICES Primary Predicate Device: CarboClear® X Pedicle Screw System (CarboFix Orthopedics Ltd.; K233793) Additional Predicate Devices: ▪ CarboClear® Hybrid Pedicle Screw System (CarboFix Orthopedics Ltd.; K240846) • CD HORIZO…
CarboFix Orthopedics, Ltd.2024—
*K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…
Summary page 6
…r® X Pedicle Screw System (CarboFix Orthopedics Ltd.; K233793) Additional Predicate Devices: ▪ CarboClear® Hybrid Pedicle Screw System (CarboFix Orthopedics Ltd.; K240846) • CD HORIZON® Spinal System (Medtronic Sofamor Danek; K082236 and more) • S4® Spinal System (Aesculap Spine; K130291 and more)…
CarboFix Orthopedics, Ltd.2024—
*K082236CD Horizon Spinal System
Summary page 6
…Additional Predicate Devices: ▪ CarboClear® Hybrid Pedicle Screw System (CarboFix Orthopedics Ltd.; K240846) • CD HORIZON® Spinal System (Medtronic Sofamor Danek; K082236 and more) • S4® Spinal System (Aesculap Spine; K130291 and more) • Dymaxeon Spine System (Back 2 Basics Direct, LCC; K192930)…
Medtronic Sofamor Danek2008—
*K130291S4 Spinal System
Summary page 6
…icle Screw System (CarboFix Orthopedics Ltd.; K240846) • CD HORIZON® Spinal System (Medtronic Sofamor Danek; K082236 and more) • S4® Spinal System (Aesculap Spine; K130291 and more) • Dymaxeon Spine System (Back 2 Basics Direct, LCC; K192930) INTENDED USE/INDICATIONS FOR USE CarboClear® Hybrid Ped…
Aesculap Implant System, Inc.2013—
*K192930Dymaxeon Spine System
Summary page 6
…N® Spinal System (Medtronic Sofamor Danek; K082236 and more) • S4® Spinal System (Aesculap Spine; K130291 and more) • Dymaxeon Spine System (Back 2 Basics Direct, LCC; K192930) INTENDED USE/INDICATIONS FOR USE CarboClear® Hybrid Pedicle Screw System The CarboClear® Hybrid Pedicle Screw System is intend…
Back 2 Basics Direct, LLC2020—

What descends from it?

No later submission names this one as a predicate yet.

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.

  • K100952Modification to Synthes Matrix SystemSynthes Spine · 2010 · 5 generations back · ◆ in the 2010 ancestors bar of FIG. 11 Class I recall
  • K070106VV Fluoro 3DBrainlab AG · 2007 · 5 generations back · ◆ in the 2007 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 6 months on median.
  • 82 of the 659 ancestors have a recall of any class; 2 have a Class I recall.

How does its category compare?

All NKB devices

NKB 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

2007: 382008: 362009: 442010: 372011: 482012: 602013: 352014: 462015: 552016: 502017: 632018: 562019: 392020: 482021: 322022: 342023: 442024: 392025: 242026 (partial year): 30
2007high 63 (2017) · low 24 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NKB

61in 2025

2007: 87 days median2008: 59 days median2009: 71 days median2010: 111 days median2011: 84 days median2012: 79 days median2013: 73 days median2014: 90 days median2015: 90 days median2016: 84 days median2017: 69 days median2018: 61 days median2019: 84 days median2020: 68 days median2021: 61 days median2022: 88 days median2023: 72 days median2024: 57 days median2025: 61 days median2026 (partial year): 91 days median
2007high 111 (2010) · low 57 (2024)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · NKB

1in 2025

2007: 42008: 52009: 332010: 42011: 32012: 132014: 3, 1 Class I2015: 32016: 12017: 12018: 32019: 12020: 12022: 52023: 22024: 32025: 12026 (partial year): 3
2007high 33 (2009) · low 0 (2013)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · NKB

1,171in 2025

2007: 342008: 822009: 1712010: 4622011: 5772012: 1,7472013: 1,9622014: 1,6712015: 1,4462016: 1,5852017: 1,6182018: 1,6842019: 1,9152020: 2,0762021: 1,7452022: 1,3392023: 9192024: 1,6142025: 1,171
2007high 2,076 (2020) · low 34 (2007)2025

MAUDE reports naming product code NKB, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20073887434
20083659582
2009447133171
2010371114462
201148843577
20126079131,747
2013357301,962
201446903 (1)1,671
2015559031,446
2016508411,585
2017636911,618
2018566131,684
2019398411,915
2020486812,076
2021326101,745
2022348851,339
202344722919
2024395731,614
2025246111,171
202630913—

What is it indicated for?

CarboClear® Hybrid Pedicle Screw System (DDD) The CarboClear® Hybrid 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 up to three levels 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.…

Read the full statement (121 words)

CarboClear® Hybrid Pedicle Screw System (DDD)

The CarboClear® Hybrid 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 up to three levels 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® Hybrid Pedicle Screw System is intended to be used with intervertebral body fusion device/s 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.

More from CarboFix Orthopedics, Ltd.

32 FDA decisions under this applicant name. See the company

  • K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd. · 2026
  • K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd. · 2024
  • K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments; CarboClear® Hybrid…CarboFix Orthopedics, Ltd. · 2024
  • K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd. · 2024
  • K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd. · 2024

Recent decisions in NKB

The NKB category page

  • K261217AnyPlus II Spinal Fixation SystemGS Medical Co., Ltd. · 2026
  • K263062NOVIX Pedicle Screw SystemTdm Co., Ltd. · 2026
  • K262712Duet™ Spinal Fixation SystemDuet Spine Holdings, LLC · 2026
  • K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc. · 2026
  • K252139Kentrospine Viktr-MIS® Pedicle screw systemRivarp Medical Pvt., Ltd. · 2026

https://510kreport.com/device/K243106 · printed Nov 6, 2026

Cite this page

510(k) Report. “K243106: CarboClear® Hybrid Pedicle 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/K243106

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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