510(k) Report

510(k) · Cleared

Cleared

Nautilus Spinal System

K140457510(k) SpecialCleared Mar 25, 201429-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 25, 2014 as substantially equivalent to K133564 (Life Spine, LLC, 2014) after a 29-day review. Its family tree reaches back 16 generations to 2004. 3 later devices descend from it.

Decided
Mar 25, 2014
Review
29 days
Class
Class II
Product code
NKB
Recalls
None
Predicates
1

Its longest line of descent runs back 16 generations to K040583 (2004). 215 ancestors in all, the oldest K781443 (1978). 3 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2013: 2 other ancestors2011: 2 other ancestors2010: 3 other ancestors2004: 26 other ancestors2003: 16 other ancestors2009: 1 other ancestor2008: 6 other ancestors2006: 11 other ancestors2005: 18 other ancestors2000: 16 other ancestors2007: 11 other ancestors2002: 10 other ancestors2001: 18 other ancestors1999: 11 other ancestors1998: 13 other ancestors1997: 6 other ancestors1996: 6 other ancestors1978: 1 other ancestor1984: 1 other ancestor1994: 3 other ancestors1995: 7 other ancestors1993: 3 other ancestors1992: 5 other ancestors1990: 2 other ancestors1985: 1 other ancestor2023: 1 descendant cleared2019: 1 descendant cleared2022: 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), K132471 (2013), K133564 (2014) 19801990200020102020
Other ancestors, by generationDescendants, by generation 2 generations back: 1 other ancestor3 generations back: 5 other ancestors4 generations back: 20 other ancestors5 generations back: 36 other ancestors6 generations back: 31 other ancestors7 generations back: 40 other ancestors8 generations back: 21 other ancestors9 generations back: 26 other ancestors10 generations back: 16 other ancestors11 generations back: 3 other ancestors 1 generation forward: 2 descendants2 generations forward: 1 descendant K133564 · Modification to Nautilus Spinal System · Life Spine, LLC · 2014K132471 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 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 · 16 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  2. 12 generations between
  3. 3 generations backK131321 CD Horizon Spinal SystemMedtronic Sofamor Danek USA · 2013
  4. 2 generations backK132471 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2013
  5. 1 generation backK133564 Modification to Nautilus Spinal SystemLife Spine, LLC · 2014
  6. This deviceK140457 Nautilus Spinal SystemLife Spine, Inc. · 2014
  7. Descendant · cites it directly · 2 of its ownK183430 Modular Spinal Fixation SystemLife Spine, Inc. · 2019
  8. Descendant · 2 generations on · 1 of its ownK220341 ARx Modular Spinal SystemLife Spine, Inc. · 2022
  9. Descendant · cites it directly · 0 of its ownK233455 ARx MIS Spinal Screw SystemLife Spine, Inc. · 2023
Show all 16 generations
  1. Root · 16 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  2. 15 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  3. 14 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
  4. 13 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
  5. 12 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
  6. 11 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
  7. 10 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
  8. 9 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
  9. 8 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
  10. 7 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
  11. 6 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
  12. 5 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
  13. 4 generations backK121680 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
  14. 3 generations backK131321 CD Horizon Spinal SystemMedtronic Sofamor Danek USA · 2013
  15. 2 generations backK132471 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2013
  16. 1 generation backK133564 Modification to Nautilus Spinal SystemLife Spine, LLC · 2014
  17. This deviceK140457 Nautilus Spinal SystemLife Spine, Inc. · 2014

Most influential descendants

Showing 3 of 3 · See all
  • K183430Modular Spinal Fixation SystemLife Spine, Inc. · 2019 · cites it directly2descendants
  • K220341ARx Modular Spinal SystemLife Spine, Inc. · 2022 · 2 generations on1descendant
  • K233455ARx MIS Spinal Screw SystemLife Spine, Inc. · 2023 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−16K040583Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2004—
−15K041118Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek2004—
−14K042025Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.20044
−13K043151Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005—
−12K050809CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2005—
−11K052187Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005—
−10K053101CD Horizon Spinal SystemMedtronic Sofamor Danek2006—
−9K091442CD Horizon Spinal SystemMedtronic Sofamor Danek2009—
−8K091974Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20091
−7K102555CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2010—
−6K112473CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2011—
−5K113174CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20111
−4K121680CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2012—
−3K131321CD Horizon Spinal SystemMedtronic Sofamor Danek USA2013—
−2K132471CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2013—
−1K133564Modification to Nautilus Spinal SystemLife Spine, LLC2014—
0 (this device)K140457Nautilus Spinal SystemLife Spine, Inc.2014—
+1K183430Modular Spinal Fixation SystemLife Spine, Inc.2019—
+2K220341ARx Modular Spinal SystemLife Spine, Inc.2022—
+1K233455ARx MIS Spinal Screw SystemLife Spine, Inc.2023—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197810
198410
198510
199020
199250
199330
199430
199570
199660
199760
1998130
1999110
2000160
2001180
2002100
2003160
2004260
2005180
2006110
2007110
200860
200910
201030
201120
201320

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201910
202210
202310
FIG. 1 — Lineage of K140457, 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? (1)

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
*K133564Modification to Nautilus Spinal System
Summary page 1
…Class IIl MNH, CFR 888.3070, Class 11 M4NI, CFR 888.3070, Class 11 Predicate Device: NAUTILUS Spinal System (K 133 564) Device Description: The NAUTILUS Thoracolumbar Spinal System consists of an assortment of rods, screws, cross connectors, a…
Life Spine, LLC2014—

Also cleared against K133564: 2 other devices →

What descends from it? (3)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K183430Modular Spinal Fixation SystemLife Spine, Inc.20192
K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230

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 10 years and passes through 6 companies; a new generation was cleared every 4 months on median.
  • 20 of the 215 ancestors have a recall of any class.
  • Of its descendants, K183430 (Life Spine, Inc., 2019) has gone furthest, with 2 descendants of its own.
  • 2 other devices also cite its predicate K133564.

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. 2014, 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 aligrnent 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 NAUTILUS Spinal System, when properly used, is intended for posterior pedicle screw fixation of the non-cervical posterior spine in skeletally mature patients. It provides stabilization and…

Read the full statement (144 words)

Internal fixation implants are load-sharing devices intended to stabilize and maintain aligrnent 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 NAUTILUS Spinal System, when properly used, is intended for posterior pedicle screw fixation of the non-cervical posterior spine in skeletally mature patients. It provides stabilization and immobilization of spinal segments as an adjunct to fusion.

When used as a posterior spine thoracic/lumbar system, the NAUTILUS Spinal 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.

Indications for use as stated in the FDA summary.

Also cleared against K133564

2 other devices cite the same predicate.

  • K233455ARx MIS Spinal Screw SystemLife Spine, Inc. · 2023
  • K191575ARx Spinal SystemLife Spine, Inc. · 2019

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/K140457 · printed Nov 6, 2026

Cite this page

510(k) Report. “K140457: Nautilus 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/K140457

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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