510(k) · Cleared
ClearedNautilus Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Life Spine, Inc. · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Jul 14, 2015 as substantially equivalent to K141222 (Life Spine, Inc., 2015) and 4 other predicates after a 70-day review. Its family tree reaches back 17 generations to 2004. 1 of the 331 devices in its family, counting itself, has a Class I recall. 12 later devices descend from it.
- Decided
- Jul 14, 2015
- Review
- 70 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 17 generations to K040583 (2004). 318 ancestors in all, the oldest K781443 (1978). 12 later devices descend from it, 4 citing it directly. 1 of the 331 devices in this family, counting this one, has a Class I recall.
- Root · 17 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 13 generations between
- 3 generations backK132111 CD Horizon Spinal SystemMedtronic Sofamor Danek USA · 2013
- 2 generations backK132866 Nautilus Spinal SystemLife Spine, Inc. · 2013
- 1 generation backK141222 Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc. · 2015
- This deviceK151196 Nautilus Spinal SystemLife Spine, Inc. · 2015
- Descendant · cites it directly · 10 of its ownK191575 ARx Spinal SystemLife Spine, Inc. · 2019
- Descendant · cites it directly · 9 of its ownK200070 ARx Spinal SystemLife Spine, Inc. · 2020
- Descendant · 2 generations on · 5 of its ownK203163 ARx Illiac Spinal Screw SystemLife Spine, Inc. · 2020
- Descendant · cites it directly · 2 of its ownK183430 Modular Spinal Fixation SystemLife Spine, Inc. · 2019
- Descendant · 3 generations on · 1 of its ownK241464 ARx® SAI Implant SystemLife Spine, Inc. · 2024
Show all 17 generations
- Root · 17 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 16 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 15 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
- 14 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 13 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
- 12 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 11 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
- 10 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
- 9 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
- 8 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
- 7 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
- 6 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
- 5 generations backK121680 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
- 4 generations backK131321 CD Horizon Spinal SystemMedtronic Sofamor Danek USA · 2013
- 3 generations backK132111 CD Horizon Spinal SystemMedtronic Sofamor Danek USA · 2013
- 2 generations backK132866 Nautilus Spinal SystemLife Spine, Inc. · 2013
- 1 generation backK141222 Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc. · 2015
- This deviceK151196 Nautilus Spinal SystemLife Spine, Inc. · 2015
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K100952 Modification to Synthes Matrix System3 generations back · 2010
Most influential descendants
Showing 5 of 12 · See all- K191575ARx Spinal SystemLife Spine, Inc. · 2019 · cites it directly10descendants
- K200070ARx Spinal SystemLife Spine, Inc. · 2020 · cites it directly9descendants
- K203163ARx Illiac Spinal Screw SystemLife Spine, Inc. · 2020 · 2 generations on5descendants
- K183430Modular Spinal Fixation SystemLife Spine, Inc. · 2019 · cites it directly2descendants
- K241464ARx® SAI Implant SystemLife Spine, Inc. · 2024 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K040583 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −16 | K041118 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −15 | K042025 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2004 | 4 |
| −14 | K043151 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −13 | K050809 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2005 | — |
| −12 | K052187 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −11 | K053101 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −10 | K091442 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2009 | — |
| −9 | K091974 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2009 | 1 |
| −8 | K102555 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2010 | — |
| −7 | K112473 | CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2011 | — |
| −6 | K113174 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2011 | 1 |
| −5 | K121680 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2012 | — |
| −4 | K131321 | CD Horizon Spinal System | Medtronic Sofamor Danek USA | 2013 | — |
| −3 | K132111 | CD Horizon Spinal System | Medtronic Sofamor Danek USA | 2013 | — |
| −2 | K132866 | Nautilus Spinal System | Life Spine, Inc. | 2013 | — |
| −1 | K141222 | Nautilus Spinal System and Solstice Oct System | Life Spine, Inc. | 2015 | — |
| 0 (this device) | K151196 | Nautilus Spinal System | Life Spine, Inc. | 2015 | — |
| +1 | K191575 | ARx Spinal System | Life Spine, Inc. | 2019 | — |
| +1 | K200070 | ARx Spinal System | Life Spine, Inc. | 2020 | — |
| +2 | K203163 | ARx Illiac Spinal Screw System | Life Spine, Inc. | 2020 | — |
| +1 | K183430 | Modular Spinal Fixation System | Life Spine, Inc. | 2019 | — |
| +3 | K241464 | ARx® SAI Implant System | Life Spine, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1990 | 2 | 0 |
| 1992 | 5 | 0 |
| 1993 | 4 | 0 |
| 1994 | 3 | 0 |
| 1995 | 9 | 0 |
| 1996 | 7 | 0 |
| 1997 | 7 | 0 |
| 1998 | 15 | 0 |
| 1999 | 13 | 0 |
| 2000 | 19 | 0 |
| 2001 | 22 | 0 |
| 2002 | 13 | 0 |
| 2003 | 21 | 0 |
| 2004 | 31 | 0 |
| 2005 | 24 | 0 |
| 2006 | 18 | 0 |
| 2007 | 23 | 0 |
| 2008 | 17 | 0 |
| 2009 | 13 | 0 |
| 2010 | 10 | 1 |
| 2011 | 7 | 0 |
| 2012 | 5 | 0 |
| 2013 | 5 | 0 |
| 2014 | 3 | 0 |
| 2015 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 2 | 0 |
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 K223494 CD Horizon Spinal Systemscore 40.4 · 30 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K141222 | Nautilus Spinal System and Solstice Oct SystemSummary page 4…ass II MNI, CFR 888.3070, Class II OSH, CFR 888.3070, Class II Primary Predicate: The Nautilus Spinal System (K141222) Additional Predicates: The Arx Spinal System (K061600) The Pilot Spinal System (K111729)… | 2015 |
| * | K061600 | Arx Spinal SystemSummary page 4…I OSH, CFR 888.3070, Class II Primary Predicate: The Nautilus Spinal System (K141222) Additional Predicates: The Arx Spinal System (K061600) The Pilot Spinal System (K111729) The Globus Creo Stabilization System (K143… | 2006 |
| * | K111729 | Pilot Spinal SystemSummary page 4…mary Predicate: The Nautilus Spinal System (K141222) Additional Predicates: The Arx Spinal System (K061600) The Pilot Spinal System (K111729) The Globus Creo Stabilization System (K143633) Medtronic CD Horizon (K143569… | 2011 |
| * | K143633 | CREO Stabilization SystemSummary page 4…redicates: The Arx Spinal System (K061600) The Pilot Spinal System (K111729) The Globus Creo Stabilization System (K143633) Medtronic CD Horizon (K143569) Device Description: The NAUTILUS Thoracolumbar Spinal System consis… | 2015 |
| * | K143569 | CD HORIZON Spinal SystemSummary page 4…The Pilot Spinal System (K111729) The Globus Creo Stabilization System (K143633) Medtronic CD Horizon (K143569) Device Description: The NAUTILUS Thoracolumbar Spinal System consists of an assortment of rods, screws, cross connectors, an… | 2015 |
What descends from it? (12)
See all 124 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 · 3 generations back · ◆ in the 2010 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 11 years and passes through 5 companies; a new generation was cleared every 4 months on median.
- 35 of the 318 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K191575 (Life Spine, Inc., 2019) has gone furthest, with 10 descendants of its own.
- 1 other device also cites its predicate K141222.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · NKB
24in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NKB
61in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NKB
1in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · NKB
1,171in 2025
MAUDE reports naming product code NKB, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 38 | 87 | 4 | 34 |
| 2008 | 36 | 59 | 5 | 82 |
| 2009 | 44 | 71 | 33 | 171 |
| 2010 | 37 | 111 | 4 | 462 |
| 2011 | 48 | 84 | 3 | 577 |
| 2012 | 60 | 79 | 13 | 1,747 |
| 2013 | 35 | 73 | 0 | 1,962 |
| 2014 | 46 | 90 | 3 (1) | 1,671 |
| 2015 | 55 | 90 | 3 | 1,446 |
| 2016 | 50 | 84 | 1 | 1,585 |
| 2017 | 63 | 69 | 1 | 1,618 |
| 2018 | 56 | 61 | 3 | 1,684 |
| 2019 | 39 | 84 | 1 | 1,915 |
| 2020 | 48 | 68 | 1 | 2,076 |
| 2021 | 32 | 61 | 0 | 1,745 |
| 2022 | 34 | 88 | 5 | 1,339 |
| 2023 | 44 | 72 | 2 | 919 |
| 2024 | 39 | 57 | 3 | 1,614 |
| 2025 | 24 | 61 | 1 | 1,171 |
| 2026 | 30 | 91 | 3 | — |
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 Thoracolumbar Spinal System, when properly used, is intended for posterior pedicle screw fixation of the non-cervical posterior spine in skeletally mature patients and for pediatric…
Read the full statement (200 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 Thoracolumbar Spinal 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 NAUTILUS Thoracolumbar 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.
In order to achieve additional levels of fixation in skeletally mature patients, the NAUTILUS Thoracolumbar Spinal System 5.5 rod system may be connected to the Solstice OccipitoCervicoThoracic Fixation System’s 3.5mm rod.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151196 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151196: 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/K151196
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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