510(k) Report

510(k) · Cleared

Cleared

INERTIA® CONNEXX™ Modular Pedicle Screw System

K231799510(k) SpecialCleared Jul 20, 202330-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

Nexxt Spine, LLC · NKB Thoracolumbosacral Pedicle Screw System

Cleared on Jul 20, 2023 as substantially equivalent to K153453 (Nexxt Spine, LLC, 2016) and 6 other predicates after a 30-day review. Its family tree reaches back 22 generations to 2004.

Decided
Jul 20, 2023
Review
30 days
Class
Class II
Product code
NKB
Recalls
None
Predicates
7

Its longest line of descent runs back 22 generations to K040583 (2004). 626 ancestors in all, the oldest K781443 (1978). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2022: 1 other ancestor2016: 5 other ancestors2014: 10 other ancestors2013: 20 other ancestors2010: 26 other ancestors2009: 22 other ancestors2018: 1 other ancestor2015: 6 other ancestors2012: 15 other ancestors2011: 21 other ancestors2005: 40 other ancestors2004: 57 other ancestors2003: 32 other ancestors2002: 37 other ancestors1999: 24 other ancestors1998: 25 other ancestors1997: 16 other ancestors2017: 1 other ancestor2008: 39 other ancestors2007: 28 other ancestors2006: 33 other ancestors2001: 45 other ancestors2000: 35 other ancestors1996: 14 other ancestors1995: 17 other ancestors1994: 7 other ancestors1993: 4 other ancestors1992: 8 other ancestors1990: 4 other ancestors1984: 2 other ancestors1978: 1 other ancestor1985: 2 other ancestors1988: 2 other ancestors1987: 1 other ancestor1989: 1 other ancestor1986: 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) ×2: 2 generations cleared close together, K121680 (2012), K122862 (2012) K141605 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2014K143019 · CD HORIZON Spinal System, IPC POWEREASE System · Medtronic Sofamor Danek USA, Inc. · 2015K153463 · CD HORIZON Spinal System, IPC POWEREASE System · Medtronic Sofamor Danek USA, Inc. · 2015K170679 · CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC® POWEREASE® System, Medtronic Navigated Reusable Instruments for Use with the STEALTHSTATION® and IPC® POWEREASE® Systems · Medtronic Sofamor Danek · 2017×2: 2 generations cleared close together, K201407 (2020), K202771 (2020) K211323 · ASTRA Spine System · Spinecraft, LLC · 2021K223273 · ASTRA Spine System · Spinecraft, LLC · 202219801990200020102020
Other ancestors, by generation 1 generation back: 6 other ancestors2 generations back: 18 other ancestors3 generations back: 80 other ancestors4 generations back: 113 other ancestors5 generations back: 130 other ancestors6 generations back: 104 other ancestors7 generations back: 67 other ancestors8 generations back: 46 other ancestors9 generations back: 19 other ancestors10 generations back: 11 other ancestors11 generations back: 9 other ancestors12 generations back: 1 other ancestor K223273 · ASTRA Spine System · Spinecraft, LLC · 2022K211323 · ASTRA Spine System · Spinecraft, LLC · 2021K202771 · CD Horizon Spinal System · Medtronic · 2020K201407 · CD Horizon™ Spinal System · Medtronic Sofamor Danek USA, Inc. · 2020K170679 · CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC® POWEREASE® System, Medtronic Navigated Reusable Instruments for Use with the STEALTHSTATION® and IPC® POWEREASE® Systems · Medtronic Sofamor Danek · 2017K153463 · CD HORIZON Spinal System, IPC POWEREASE System · Medtronic Sofamor Danek USA, Inc. · 2015K143019 · CD HORIZON Spinal System, IPC POWEREASE System · Medtronic Sofamor Danek USA, Inc. · 2015K141605 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2014K122862 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2012K121680 · 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 · 2004−20−15−10−50
  1. Root · 22 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  2. 18 generations between
  3. 3 generations backK202771 CD Horizon Spinal SystemMedtronic · 2020
  4. 2 generations backK211323 ASTRA Spine SystemSpinecraft, LLC · 2021
  5. 1 generation backK223273 ASTRA Spine SystemSpinecraft, LLC · 2022
  6. This deviceK231799 INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC · 2023
Show all 22 generations
  1. Root · 22 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  2. 21 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  3. 20 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
  4. 19 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
  5. 18 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
  6. 17 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
  7. 16 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
  8. 15 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
  9. 14 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
  10. 13 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
  11. 12 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
  12. 11 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
  13. 10 generations backK121680 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
  14. 9 generations backK122862 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
  15. 8 generations backK141605 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2014
  16. 7 generations backK143019 CD HORIZON Spinal System, IPC POWEREASE SystemMedtronic Sofamor Danek USA, Inc. · 2015
  17. 6 generations backK153463 CD HORIZON Spinal System, IPC POWEREASE SystemMedtronic Sofamor Danek USA, Inc. · 2015
  18. 5 generations backK170679 CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use…Medtronic Sofamor Danek · 2017
  19. 4 generations backK201407 CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2020
  20. 3 generations backK202771 CD Horizon Spinal SystemMedtronic · 2020
  21. 2 generations backK211323 ASTRA Spine SystemSpinecraft, LLC · 2021
  22. 1 generation backK223273 ASTRA Spine SystemSpinecraft, LLC · 2022
  23. This deviceK231799 INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC · 2023
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−22K040583Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2004—
−21K041118Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek2004—
−20K042025Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.20044
−19K043151Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005—
−18K050809CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2005—
−17K052187Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005—
−16K053101CD Horizon Spinal SystemMedtronic Sofamor Danek2006—
−15K091442CD Horizon Spinal SystemMedtronic Sofamor Danek2009—
−14K091974Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20091
−13K102555CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2010—
−12K112473CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2011—
−11K113174CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20111
−10K121680CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2012—
−9K122862CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2012—
−8K141605CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2014—
−7K143019CD HORIZON Spinal System, IPC POWEREASE SystemMedtronic Sofamor Danek USA, Inc.2015—
−6K153463CD HORIZON Spinal System, IPC POWEREASE SystemMedtronic Sofamor Danek USA, Inc.2015—
−5K170679CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the…Medtronic Sofamor Danek2017—
−4K201407CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.2020—
−3K202771CD Horizon Spinal SystemMedtronic2020—
−2K211323ASTRA Spine SystemSpinecraft, LLC2021—
−1K223273ASTRA Spine SystemSpinecraft, LLC2022—
0 (this device)K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC2023—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197810
198420
198520
198620
198710
198820
198910
199040
199280
199340
199470
1995170
1996140
1997160
1998250
1999240
2000350
2001450
2002370
2003320
2004570
2005400
2006330
2007280
2008390
2009220
2010260
2011210
2012150
2013200
2014100
201560
201650
201710
201810
202210
FIG. 1 — Lineage of K231799, 2004–2023Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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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.

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. #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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K153453Inertia Pedicle Screw and Deformity Correxxion System
Summary page 5
…r cobalt chrome per ASTM F1537 (rods only). Primary Predicate: INERTIA® Pedicle Screw and Deformity Correxxion™ System (Nexxt Spine, LLC – K153453) Additional Predicates: Astra Spinal System (SpineCraft, LLC – K223273), INERTIA® Pedicle Screw System…
Nexxt Spine, LLC2016—
*K223273ASTRA Spine System
Summary page 5
…TIA® Pedicle Screw and Deformity Correxxion™ System (Nexxt Spine, LLC – K153453) Additional Predicates: Astra Spinal System (SpineCraft, LLC – K223273), INERTIA® Pedicle Screw System (Nexxt Spine, LLC – K090984, K101278, K132412,…
Spinecraft, LLC2022—
*K090984Inertia Pedicle Screw System
Summary page 5
…LLC – K153453) Additional Predicates: Astra Spinal System (SpineCraft, LLC – K223273), INERTIA® Pedicle Screw System (Nexxt Spine, LLC – K090984, K101278, K132412, K141376, K221905)] Performance Data: Mechanical testing of worst case INERTIA®…
Nexxt Spine, LLC2009—
*K101278Inertia Pedicle Screw System
Summary page 5
…– K153453) Additional Predicates: Astra Spinal System (SpineCraft, LLC – K223273), INERTIA® Pedicle Screw System (Nexxt Spine, LLC – K090984, K101278, K132412, K141376, K221905)] Performance Data: Mechanical testing of worst case INERTIA® CONNEXX™…
Nexxt Spine, LLC2010—
*K132412Inertia Mis Pedicle Screw System
Summary page 5
…3) Additional Predicates: Astra Spinal System (SpineCraft, LLC – K223273), INERTIA® Pedicle Screw System (Nexxt Spine, LLC – K090984, K101278, K132412, K141376, K221905)] Performance Data: Mechanical testing of worst case INERTIA® CONNEXX™ construc…
Nexxt Spine, LLC2013—
*K141376Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx, Struxxure Anterior…
Summary page 5
…Spinal System (SpineCraft, LLC – K223273), INERTIA® Pedicle Screw System (Nexxt Spine, LLC – K090984, K101278, K132412, K141376, K221905)] Performance Data: Mechanical testing of worst case INERTIA® CONNEXX™ constructs includ…
Nexxt Spine, LLC2014—
*K221905INERTIA CONNEXX Modular Pedicle Screw System
Summary page 5
…stem (SpineCraft, LLC – K223273), INERTIA® Pedicle Screw System (Nexxt Spine, LLC – K090984, K101278, K132412, K141376, K221905)] Performance Data: Mechanical testing of worst case INERTIA® CONNEXX™ constructs included dynami…
Nexxt Spine, LLC2022—

Also cleared against K153453: 3 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 19 years and passes through 6 companies; a new generation was cleared every 7 months on median.
  • 66 of the 626 ancestors have a recall of any class.
  • 3 other devices also cite its predicate K153453.

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. 2023, 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?

The INERTIA® CONNEXX™ Modular Pedicle Screw System is intended for immobilization and stabilization of the posterior non-cervical spine (T1-S2/Ilium) in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis…

Read the full statement (168 words)

The INERTIA® CONNEXX™ Modular Pedicle Screw System is intended for immobilization and stabilization of the posterior non-cervical spine (T1-S2/Ilium) in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, kyphosis, or lordosis), tumor, pseudarthrosis, and/or failed previous fusion.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the INERTIA® CONNEXX™ Modular Pedicle Screw System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis and congenital scoliosis. Additionally, the system is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. The INERTIA® CONNEXX™ Modular Pedicle Screw System is to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K153453

3 other devices cite the same predicate.

  • K242069Eminent Spine Scoliosis Deformity Pedicle Screw SystemEminent Spine · 2024
  • K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC · 2022
  • K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems · 2019

More from Nexxt Spine, LLC

22 FDA decisions under this applicant name. See the company

  • K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC · 2022
  • K220291NEXXT SPINE NAVIGATION SystemNexxt Spine, LLC · 2022
  • K202230NEXXT MATRIXX Stand Alone ALIF SystemNexxt Spine, LLC · 2020
  • K202192STRUXXURE®-L and STRUXXURE®-A Plate SystemNexxt Spine, LLC · 2020
  • K200969NEXXT MATRIXX SystemNexxt Spine, LLC · 2020

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/K231799 · printed Nov 5, 2026

Cite this page

510(k) Report. “K231799: INERTIA® CONNEXX™ Modular 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/K231799

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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