510(k) Report

510(k) · Cleared

Cleared

Nautilus Spinal System

K132866510(k) TraditionalCleared Oct 28, 201345-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 Oct 28, 2013 as substantially equivalent to K073480 (Life Spine, 2008) and 1 other predicate after a 45-day review. Its family tree reaches back 15 generations to 2004. 15 later devices descend from it.

Decided
Oct 28, 2013
Review
45 days
Class
Class II
Product code
NKB
Recalls
None
Predicates
2

Its longest line of descent runs back 15 generations to K040583 (2004). 87 ancestors in all, the oldest K841189 (1984). 15 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2008: 3 other ancestors2007: 4 other ancestors2009: 1 other ancestor2006: 6 other ancestors2005: 10 other ancestors2004: 17 other ancestors2003: 6 other ancestors2002: 5 other ancestors2000: 6 other ancestors1999: 1 other ancestor2011: 1 other ancestor2010: 2 other ancestors1996: 1 other ancestor2001: 6 other ancestors1998: 2 other ancestors1984: 1 other ancestor2015: 3 descendants cleared2022: 2 descendants cleared2020: 2 descendants cleared2021: 2 descendants cleared2019: 2 descendants cleared2026: 2 descendants cleared2024: 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. · 2012×2: 2 generations cleared close together, K131321 (2013), K132111 (2013) 19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 1 other ancestor3 generations back: 20 other ancestors4 generations back: 19 other ancestors5 generations back: 17 other ancestors6 generations back: 6 other ancestors7 generations back: 1 other ancestor8 generations back: 7 other ancestors 1 generation forward: 2 descendants2 generations forward: 2 descendants3 generations forward: 4 descendants4 generations forward: 4 descendants5 generations forward: 2 descendants6 generations forward: 1 descendant K132111 · 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+5
  1. Root · 15 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  2. 11 generations between
  3. 3 generations backK121680 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
  4. 2 generations backK131321 CD Horizon Spinal SystemMedtronic Sofamor Danek USA · 2013
  5. 1 generation backK132111 CD Horizon Spinal SystemMedtronic Sofamor Danek USA · 2013
  6. This deviceK132866 Nautilus Spinal SystemLife Spine, Inc. · 2013
  7. Descendant · cites it directly · 13 of its ownK141222 Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc. · 2015
  8. Descendant · 2 generations on · 12 of its ownK151196 Nautilus Spinal SystemLife Spine, Inc. · 2015
  9. Descendant · 3 generations on · 10 of its ownK191575 ARx Spinal SystemLife Spine, Inc. · 2019
  10. Descendant · 3 generations on · 9 of its ownK200070 ARx Spinal SystemLife Spine, Inc. · 2020
  11. Descendant · 4 generations on · 5 of its ownK203163 ARx Illiac Spinal Screw SystemLife Spine, Inc. · 2020
Show all 15 generations
  1. Root · 15 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  2. 14 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  3. 13 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
  4. 12 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
  5. 11 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
  6. 10 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
  7. 9 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
  8. 8 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
  9. 7 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
  10. 6 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
  11. 5 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
  12. 4 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
  13. 3 generations backK121680 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
  14. 2 generations backK131321 CD Horizon Spinal SystemMedtronic Sofamor Danek USA · 2013
  15. 1 generation backK132111 CD Horizon Spinal SystemMedtronic Sofamor Danek USA · 2013
  16. This deviceK132866 Nautilus Spinal SystemLife Spine, Inc. · 2013

Showing 5 of 15 descendants. See all descendants

Descendants cleared per year

2015: 32019: 22020: 22021: 22022: 22023: 12024: 12026: 2
2015high 3 (2015) · low 0 (2016)2026

Most influential descendants

Showing 5 of 15 · See all
  • K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc. · 2015 · cites it directly13descendants
  • K151196Nautilus Spinal SystemLife Spine, Inc. · 2015 · 2 generations on12descendants
  • K191575ARx Spinal SystemLife Spine, Inc. · 2019 · 3 generations on10descendants
  • K200070ARx Spinal SystemLife Spine, Inc. · 2020 · 3 generations on9descendants
  • K203163ARx Illiac Spinal Screw SystemLife Spine, Inc. · 2020 · 4 generations on5descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−15K040583Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2004—
−14K041118Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek2004—
−13K042025Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.20044
−12K043151Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005—
−11K050809CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2005—
−10K052187Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005—
−9K053101CD Horizon Spinal SystemMedtronic Sofamor Danek2006—
−8K091442CD Horizon Spinal SystemMedtronic Sofamor Danek2009—
−7K091974Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20091
−6K102555CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2010—
−5K112473CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2011—
−4K113174CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20111
−3K121680CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2012—
−2K131321CD Horizon Spinal SystemMedtronic Sofamor Danek USA2013—
−1K132111CD Horizon Spinal SystemMedtronic Sofamor Danek USA2013—
0 (this device)K132866Nautilus Spinal SystemLife Spine, Inc.2013—
+1K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc.2015—
+2K151196Nautilus Spinal SystemLife Spine, Inc.2015—
+3K191575ARx Spinal SystemLife Spine, Inc.2019—
+3K200070ARx Spinal SystemLife Spine, Inc.2020—
+4K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.2020—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198410
199610
199820
199910
200060
200160
200250
200360
2004170
2005100
200660
200740
200830
200910
201020
201110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201530
201920
202020
202120
202220
202310
202410
202620
FIG. 1 — Lineage of K132866, 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.

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? (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
*K073480Life Spine Cross Connector
Summary page 1
…ss III MNH, CFR 888.3070, Class 11 MNI, CFR 888.3070, Class 11 Predicate Device: Life Spine Cross Connector (K073480) CD Horizon Spinal System (K1321 11) Device Description: The NAUTILUS Thoracolumbar Spinal System…
Life Spine2008—
*K132111CD Horizon Spinal System
Summary page 1
…MNI, CFR 888.3070, Class 11 Predicate Device: Life Spine Cross Connector (K073480) CD Horizon Spinal System (K1321 11) Device Description: The NAUTILUS Thoracolumbar Spinal System consists of an assortment of rods, screws, cross connectors, a…
Medtronic Sofamor Danek USA2013—

Also cleared against K073480: 1 other device →

What descends from it? (15)

See all 15

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

NumberDeviceApplicantDecidedDescendants
K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc.201513
K150390Nautilus Spinal SystemLife Spine, Inc.20150

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 9 years and passes through 5 companies; a new generation was cleared every 4 months on median.
  • 11 of the 87 ancestors have a recall of any class.
  • Of its descendants, K141222 (Life Spine, Inc., 2015) has gone furthest, with 13 descendants of its own.
  • 1 other device also cites its predicate K073480.

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. 2013, 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 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 (145 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 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 K073480

1 other device cites the same predicate.

  • K150390Nautilus Spinal SystemLife Spine, Inc. · 2015

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/K132866 · printed Nov 5, 2026

Cite this page

510(k) Report. “K132866: Nautilus Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K132866

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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