510(k) Report

510(k) · Cleared

Cleared

Modular Spinal Fixation System

K183430510(k) TraditionalCleared Mar 13, 201992-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

Life Spine, Inc. · NKB Thoracolumbosacral Pedicle Screw System

Cleared on Mar 13, 2019 as substantially equivalent to K171082 (Orthofix, Inc., 2017) and 2 other predicates after a 92-day review. Its family tree reaches back 18 generations to 2004. 1 of the 386 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it.

Decided
Mar 13, 2019
Review
92 days
Class
Class II
Product code
NKB
Recalls
None
Predicates
3

Its longest line of descent runs back 18 generations to K040583 (2004). 383 ancestors in all, the oldest K781443 (1978). 2 later devices descend from it, 1 citing it directly. 1 of the 386 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 2017: 1 other ancestor2014: 5 other ancestors2016: 1 other ancestor2015: 3 other ancestors2011: 11 other ancestors2008: 23 other ancestors2006: 21 other ancestors2013: 8 other ancestors2012: 9 other ancestors2009: 15 other ancestors2007: 23 other ancestors2005: 26 other ancestors2003: 24 other ancestors2002: 22 other ancestors2001: 26 other ancestors2000: 21 other ancestors1996: 9 other ancestors2010: 13 other ancestors, 1 with a Class I recall12004: 35 other ancestors1999: 14 other ancestors1998: 18 other ancestors1995: 10 other ancestors1997: 9 other ancestors1994: 4 other ancestors1993: 4 other ancestors1984: 1 other ancestor1978: 1 other ancestor1985: 1 other ancestor1992: 5 other ancestors1990: 2 other ancestors2022: 1 descendant cleared2023: 1 descendant 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. · 2012×3: 3 generations cleared close together, K131321 (2013), K132111 (2013), K132866 (2013) ×2: 2 generations cleared close together, K141222 (2015), K151196 (2015) 19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 7 other ancestors3 generations back: 29 other ancestors4 generations back: 64 other ancestors, 1 with a Class I recall15 generations back: 89 other ancestors6 generations back: 101 other ancestors7 generations back: 46 other ancestors8 generations back: 21 other ancestors9 generations back: 6 other ancestors 1 generation forward: 1 descendant2 generations forward: 1 descendant K151196 · Nautilus Spinal System · Life Spine, Inc. · 2015K141222 · Nautilus Spinal System and Solstice Oct System · Life Spine, Inc. · 2015K132866 · Nautilus Spinal System · Life Spine, Inc. · 2013K132111 · 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 · 2004−15−10−50
  1. Root · 18 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  2. 14 generations between
  3. 3 generations backK132866 Nautilus Spinal SystemLife Spine, Inc. · 2013
  4. 2 generations backK141222 Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc. · 2015
  5. 1 generation backK151196 Nautilus Spinal SystemLife Spine, Inc. · 2015
  6. This deviceK183430 Modular Spinal Fixation SystemLife Spine, Inc. · 2019
  7. Descendant · cites it directly · 1 of its ownK220341 ARx Modular Spinal SystemLife Spine, Inc. · 2022
  8. Descendant · 2 generations on · 0 of its ownK233455 ARx MIS Spinal Screw SystemLife Spine, Inc. · 2023
Show all 18 generations
  1. Root · 18 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  2. 17 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  3. 16 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
  4. 15 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
  5. 14 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
  6. 13 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
  7. 12 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
  8. 11 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
  9. 10 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
  10. 9 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
  11. 8 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
  12. 7 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
  13. 6 generations backK121680 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
  14. 5 generations backK131321 CD Horizon Spinal SystemMedtronic Sofamor Danek USA · 2013
  15. 4 generations backK132111 CD Horizon Spinal SystemMedtronic Sofamor Danek USA · 2013
  16. 3 generations backK132866 Nautilus Spinal SystemLife Spine, Inc. · 2013
  17. 2 generations backK141222 Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc. · 2015
  18. 1 generation backK151196 Nautilus Spinal SystemLife Spine, Inc. · 2015
  19. This deviceK183430 Modular Spinal Fixation SystemLife Spine, Inc. · 2019

Class I recalls in this family

  • K100952 Modification to Synthes Matrix System4 generations back · 2010

Most influential descendants

Showing 2 of 2 · See all
  • K220341ARx Modular Spinal SystemLife Spine, Inc. · 2022 · cites it directly1descendant
  • K233455ARx MIS Spinal Screw SystemLife Spine, Inc. · 2023 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−18K040583Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2004—
−17K041118Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek2004—
−16K042025Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.20044
−15K043151Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005—
−14K050809CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2005—
−13K052187Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005—
−12K053101CD Horizon Spinal SystemMedtronic Sofamor Danek2006—
−11K091442CD Horizon Spinal SystemMedtronic Sofamor Danek2009—
−10K091974Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20091
−9K102555CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2010—
−8K112473CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2011—
−7K113174CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20111
−6K121680CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2012—
−5K131321CD Horizon Spinal SystemMedtronic Sofamor Danek USA2013—
−4K132111CD Horizon Spinal SystemMedtronic Sofamor Danek USA2013—
−3K132866Nautilus Spinal SystemLife Spine, Inc.2013—
−2K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc.2015—
−1K151196Nautilus Spinal SystemLife Spine, Inc.2015—
0 (this device)K183430Modular Spinal Fixation SystemLife Spine, Inc.2019—
+1K220341ARx Modular Spinal SystemLife Spine, Inc.2022—
+2K233455ARx MIS Spinal Screw SystemLife Spine, Inc.2023—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197810
198410
198510
199020
199250
199340
199440
1995100
199690
199790
1998180
1999140
2000210
2001260
2002220
2003240
2004350
2005260
2006210
2007230
2008230
2009150
2010131
2011110
201290
201380
201450
201530
201610
201710

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202210
202310
FIG. 1 — Lineage of K183430, 2004–2023Source: 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.

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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K171082Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline…
Summary page 4
…mmon Name: Pedicle Screw Spinal System Classification: NKB, CFR 888.3070, Class II Primary Predicate: Orthofix Janus Spinal System (K171082) Additional Predicate: Life Spine Centerline Spinal System (K151196) Life Spine Nautilus Spinal…
Orthofix, Inc.20171
*K151196Nautilus Spinal System
Summary page 4
…NKB, CFR 888.3070, Class II Primary Predicate: Orthofix Janus Spinal System (K171082) Additional Predicate: Life Spine Centerline Spinal System (K151196) Life Spine Nautilus Spinal System (K140457) Device Description: The Modular Spinal Fixation System…
Life Spine, Inc.2015—
*K140457Nautilus Spinal System
Summary page 4
…fix Janus Spinal System (K171082) Additional Predicate: Life Spine Centerline Spinal System (K151196) Life Spine Nautilus Spinal System (K140457) Device Description: The Modular Spinal Fixation System consists of an assortment of rods, modular screws, modular tulips, cro…
Life Spine, Inc.2014—

Also cleared against K171082: 5 other devices →

What descends from it? (2)

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

NumberDeviceApplicantDecidedDescendants
K220341ARx Modular Spinal SystemLife Spine, Inc.20221

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 15 years and passes through 5 companies; a new generation was cleared every 5 months on median.
  • 45 of the 383 ancestors have a recall of any class; 1 has a Class I recall.
  • Of its descendants, K220341 (Life Spine, Inc., 2022) has gone furthest, with 1 descendant of its own.
  • 5 other devices also cite its predicate K171082.

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. 2019, 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?

Internal fixation implants are load-sharing devices intended to stabilize and maintain alignment until normal healing occurs. Implants are not intended to replace normal body structures or bear the weight of the body in the presence of incomplete bone healing. The Modular Spinal Fixation System, when properly used, is intended for posterior pedicle screw fixation of the non-cervical posterior spine in skeletally mature patients and for pediatric patients…

Read the full statement (211 words)

Internal fixation implants are load-sharing devices intended to stabilize and maintain alignment until normal healing occurs. Implants are not intended to replace normal body structures or bear the weight of the body in the presence of incomplete bone healing.

The Modular Spinal Fixation System, when properly used, is intended for posterior pedicle screw fixation of the non-cervical posterior spine in skeletally mature patients and for pediatric patients to treat adolescent idiopathic scoliosis (4.75 systems only). It provides stabilization and immobilization of spinal segments as an adjunct to fusion. Pediatric pedicle screw fixation is limited to a posterior approach.

When used as a posterior spine thoracic/lumbar system, the Modular Spinal Fixation System is indicated for one or more of the following: (1) degenerative disc disease (is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), (2) trauma (i.e. fracture or dislocation), (3) curvatures (scoliosis, kyphosis, and/or lordosis), (4) spinal tumor, (5) failed previous fusion (6) pseudarthrosis, (7) spinal stenosis, (8) spondylolisthesis.

In order to achieve additional levels of fixation in skeletally mature patients, the Modular Spinal Fixation System may be connected to the Solstice OccipitoCervicoThoracic Fixation System’s 3.5mm rod. The Modular Spinal Fixation System is intended to be used with autograft or allograft.

Indications for use as stated in the FDA summary.

Also cleared against K171082

5 other devices cite the same predicate.

  • K210539CoreLink Midline Fixation SystemCorelink, LLC · 2021
  • K182416NOVA Minimally Invasive SystemBaui Biotech Co., Ltd. · 2019
  • K180980ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization SystemCamber Spine Technologies, LLC · 2018
  • K180179Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System; Firebird® NXG Spinal Fixation…Orthofix, Inc. · 2018
  • K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc. · 2017

More from Life Spine, Inc.

85 FDA decisions under this applicant name. See the company

  • K261430TruLift Expandable SystemLife Spine, Inc. · 2026
  • K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc. · 2026
  • K260837VersaLift Expandable SystemLife Spine, Inc. · 2026
  • K254274ARx® SAI Implant SystemLife Spine, Inc. · 2026
  • K253748Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer SystemLife Spine, Inc. · 2026

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/K183430 · printed Nov 6, 2026

Cite this page

510(k) Report. “K183430: Modular Spinal Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K183430

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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