510(k) Report

510(k) · Cleared

Cleared

LineSider® Spinal System

K231098510(k) TraditionalCleared Aug 7, 2023111-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

Integrity Implants, Inc. · NKB Thoracolumbosacral Pedicle Screw System

Cleared on Aug 7, 2023 as substantially equivalent to K190360 (Integrity Implants, Inc., 2019) and 1 other predicate after a 111-day review. Its family tree reaches back 21 generations to 2004. 1 of the 371 devices in its family, counting itself, has a Class I recall. 3 later devices descend from it.

Decided
Aug 7, 2023
Review
111 days
Class
Class II
Product code
NKB
Recalls
None
Predicates
2

Its longest line of descent runs back 21 generations to K040583 (2004). 367 ancestors in all, the oldest K781443 (1978). 3 later devices descend from it, 1 citing it directly. 1 of the 371 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 2017: 1 other ancestor2004: 34 other ancestors2016: 3 other ancestors2014: 7 other ancestors2013: 6 other ancestors2012: 2 other ancestors2009: 10 other ancestors2008: 16 other ancestors2006: 18 other ancestors2011: 8 other ancestors2010: 10 other ancestors, 1 with a Class I recall12007: 16 other ancestors2005: 25 other ancestors2003: 23 other ancestors2001: 26 other ancestors1998: 17 other ancestors1997: 11 other ancestors1994: 6 other ancestors2015: 2 other ancestors2002: 16 other ancestors2000: 24 other ancestors1999: 16 other ancestors1996: 9 other ancestors1995: 15 other ancestors1984: 2 other ancestors1978: 1 other ancestor1993: 4 other ancestors1992: 7 other ancestors1990: 3 other ancestors1988: 2 other ancestors1987: 1 other ancestor1989: 1 other ancestor1986: 2 other ancestors1985: 2 other ancestors2023: 1 descendant cleared2026: 2 descendants cleared×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 · 2016K170126 · NuVasive® Reline® 4.5-5.0 System · Nu Vasive, Incorporated · 2017K190360 · LineSider™ Spinal System · Integrity Implants, Inc. · 2019K203367 · LineSider™ Spinal System · Integrity Implants, Inc. · 2020 · recalled19801990200020102020
Other ancestors, by generationDescendants, by generation 2 generations back: 2 other ancestors3 generations back: 9 other ancestors4 generations back: 27 other ancestors, 1 with a Class I recall15 generations back: 61 other ancestors6 generations back: 66 other ancestors7 generations back: 46 other ancestors8 generations back: 51 other ancestors9 generations back: 28 other ancestors10 generations back: 22 other ancestors11 generations back: 20 other ancestors12 generations back: 8 other ancestors13 generations back: 4 other ancestors14 generations back: 2 other ancestors 1 generation forward: 1 descendant2 generations forward: 1 descendant3 generations forward: 1 descendant K203367 · LineSider™ Spinal System · Integrity Implants, Inc. · 2020 · recalledK190360 · LineSider™ Spinal System · Integrity Implants, Inc. · 2019K170126 · NuVasive® Reline® 4.5-5.0 System · Nu Vasive, Incorporated · 2017K160989 · 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 · 2004−20−15−10−50
  1. Root · 21 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  2. 17 generations between
  3. 3 generations backK170126 NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated · 2017
  4. 2 generations backK190360 LineSider™ Spinal SystemIntegrity Implants, Inc. · 2019
  5. 1 generation backK203367 LineSider™ Spinal SystemIntegrity Implants, Inc. · 2020 · Recalled
  6. This deviceK231098 LineSider® Spinal SystemIntegrity Implants, Inc. · 2023
  7. Descendant · cites it directly · 2 of its ownK232413 Fusion Robotic Navigation SystemAlphatec Spine, Inc. · 2023
  8. Descendant · 2 generations on · 1 of its ownK252597 Valence Robotic Navigation System; Valence Robotic Navigation…Alphatec Spine, Inc. · 2026
  9. Descendant · 3 generations on · 0 of its ownK261284 Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal…Alphatec Spine, Inc. · 2026
Show all 21 generations
  1. Root · 21 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  2. 20 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  3. 19 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
  4. 18 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
  5. 17 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
  6. 16 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
  7. 15 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
  8. 14 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
  9. 13 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
  10. 12 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
  11. 11 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
  12. 10 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
  13. 9 generations backK121680 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
  14. 8 generations backK131321 CD Horizon Spinal SystemMedtronic Sofamor Danek USA · 2013
  15. 7 generations backK132111 CD Horizon Spinal SystemMedtronic Sofamor Danek USA · 2013
  16. 6 generations backK141604 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2014
  17. 5 generations backK143684 NuVasive Reline SystemNu Vasive, Incorporated · 2015
  18. 4 generations backK160989 NuVasive® Reline® SystemNu Vasive, Incorporated · 2016
  19. 3 generations backK170126 NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated · 2017
  20. 2 generations backK190360 LineSider™ Spinal SystemIntegrity Implants, Inc. · 2019
  21. 1 generation backK203367 LineSider™ Spinal SystemIntegrity Implants, Inc. · 2020 · Recalled
  22. This deviceK231098 LineSider® Spinal SystemIntegrity Implants, Inc. · 2023

Class I recalls in this family

  • K100952 Modification to Synthes Matrix System4 generations back · 2010

Most influential descendants

Showing 3 of 3 · See all
  • K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc. · 2023 · cites it directly2descendants
  • K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc. · 2026 · 2 generations on1descendant
  • K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc. · 2026 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−21K040583Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2004—
−20K041118Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek2004—
−19K042025Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.20044
−18K043151Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005—
−17K050809CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2005—
−16K052187Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005—
−15K053101CD Horizon Spinal SystemMedtronic Sofamor Danek2006—
−14K091442CD Horizon Spinal SystemMedtronic Sofamor Danek2009—
−13K091974Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20091
−12K102555CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2010—
−11K112473CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2011—
−10K113174CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20111
−9K121680CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2012—
−8K131321CD Horizon Spinal SystemMedtronic Sofamor Danek USA2013—
−7K132111CD Horizon Spinal SystemMedtronic Sofamor Danek USA2013—
−6K141604CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2014—
−5K143684NuVasive Reline SystemNu Vasive, Incorporated2015—
−4K160989NuVasive® Reline® SystemNu Vasive, Incorporated2016—
−3K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated2017—
−2K190360LineSider™ Spinal SystemIntegrity Implants, Inc.2019—
−1K203367LineSider™ Spinal SystemIntegrity Implants, Inc.20204
0 (this device)K231098LineSider® Spinal SystemIntegrity Implants, Inc.2023—
+1K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.2023—
+2K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For…Alphatec Spine, Inc.2026—
+3K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation…Alphatec Spine, Inc.2026—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197810
198420
198520
198620
198710
198820
198910
199030
199270
199340
199460
1995150
199690
1997110
1998170
1999160
2000240
2001260
2002160
2003230
2004340
2005250
2006180
2007160
2008160
2009100
2010101
201180
201220
201360
201470
201520
201630
201710

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202310
202620
FIG. 1 — Lineage of K231098, 2004–2026Source: 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.

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 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? (2)

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
*K190360LineSider™ Spinal System
Summary page 6
…quivalence of the subject LineSider® Spinal System to the following legally marketed predicate devices is claimed: Primary Predicate: LineSider Spinal System K190360 (SE 06/21/2019) Additional Predicate: LineSider Spinal System K203367 (SE 12/03/2020) X. Brief Discussion of the Non-C…
Integrity Implants, Inc.2019—
*K203367LineSider™ Spinal System
Summary page 6
…marketed predicate devices is claimed: Primary Predicate: LineSider Spinal System K190360 (SE 06/21/2019) Additional Predicate: LineSider Spinal System K203367 (SE 12/03/2020) X. Brief Discussion of the Non-Clinical and Clinical Tests Submitted Integrity Implants has conducted…
Integrity Implants, Inc.20204

Also cleared against K190360: 4 other devices →

What descends from it? (3)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232

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.

  • K100952Modification to Synthes Matrix SystemSynthes Spine · 2010 · 4 generations back · ◆ in the 2010 ancestors bar of FIG. 11 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.
  • 44 of the 367 ancestors have a recall of any class; 1 has a Class I recall.
  • Of its descendants, K232413 (Alphatec Spine, Inc., 2023) has gone furthest, with 2 descendants of its own.
  • 4 other devices also cite its predicate K190360.

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?

LineSider® Spinal System, with or without MIS instrumentation, is intended for posterior, non-cervical fixation 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…

Read the full statement (152 words)

LineSider® Spinal System, with or without MIS instrumentation, is intended for posterior, non-cervical fixation 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 and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, LineSider® Spinal 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, LineSider Spinal System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/spondylolysis; fracture caused by tumor and/or trauma. LineSider® Spinal System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

Indications for use as stated in the FDA summary.

Also cleared against K190360

4 other devices cite the same predicate.

  • K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc. · 2025
  • K212088Integrity Implants Navigated InstrumentsIntegrity Implants, Inc. · 2021
  • K210539CoreLink Midline Fixation SystemCorelink, LLC · 2021
  • K203367LineSider™ Spinal SystemIntegrity Implants, Inc. · 20204 recalls

More from Integrity Implants, Inc.

11 FDA decisions under this applicant name. See the company

  • K213355Toro-L Interbody Fusion SystemIntegrity Implants, Inc. · 2022
  • K220453FlareHawk Interbody Fusion SystemIntegrity Implants, Inc. · 2022
  • K212088Integrity Implants Navigated InstrumentsIntegrity Implants, Inc. · 2021
  • K203038Toro-L Interbody Fusion SystemIntegrity Implants, Inc. · 2021
  • K203367LineSider™ Spinal SystemIntegrity Implants, Inc. · 20204 recalls

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/K231098 · printed Nov 6, 2026

Cite this page

510(k) Report. “K231098: LineSider® Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231098

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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