510(k) · Cleared
ClearedNautilus Spinal System and Solstice Oct 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 Feb 12, 2015 as substantially equivalent to K090343 (Life Spine, 2009) and 6 other predicates after a 276-day review. Its family tree reaches back 16 generations to 2004. 13 later devices descend from it.
- Decided
- Feb 12, 2015
- Review
- 276 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 16 generations to K040583 (2004). 300 ancestors in all, the oldest K781443 (1978). 13 later devices descend from it, 2 citing it directly.
- Root · 16 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 12 generations between
- 3 generations backK131321 CD Horizon Spinal SystemMedtronic Sofamor Danek USA · 2013
- 2 generations backK132111 CD Horizon Spinal SystemMedtronic Sofamor Danek USA · 2013
- 1 generation backK132866 Nautilus Spinal SystemLife Spine, Inc. · 2013
- This deviceK141222 Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc. · 2015
- Descendant · cites it directly · 12 of its ownK151196 Nautilus Spinal SystemLife Spine, Inc. · 2015
- Descendant · 2 generations on · 10 of its ownK191575 ARx Spinal SystemLife Spine, Inc. · 2019
- Descendant · 2 generations on · 9 of its ownK200070 ARx Spinal SystemLife Spine, Inc. · 2020
- Descendant · 3 generations on · 5 of its ownK203163 ARx Illiac Spinal Screw SystemLife Spine, Inc. · 2020
- Descendant · 2 generations on · 2 of its ownK183430 Modular Spinal Fixation SystemLife Spine, Inc. · 2019
Show all 16 generations
- Root · 16 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 15 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 14 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
- 13 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 12 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
- 11 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 10 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
- 9 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
- 8 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
- 7 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
- 6 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
- 5 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
- 4 generations backK121680 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
- 3 generations backK131321 CD Horizon Spinal SystemMedtronic Sofamor Danek USA · 2013
- 2 generations backK132111 CD Horizon Spinal SystemMedtronic Sofamor Danek USA · 2013
- 1 generation backK132866 Nautilus Spinal SystemLife Spine, Inc. · 2013
- This deviceK141222 Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc. · 2015
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K151196Nautilus Spinal SystemLife Spine, Inc. · 2015 · cites it directly12descendants
- K191575ARx Spinal SystemLife Spine, Inc. · 2019 · 2 generations on10descendants
- K200070ARx Spinal SystemLife Spine, Inc. · 2020 · 2 generations on9descendants
- K203163ARx Illiac Spinal Screw SystemLife Spine, Inc. · 2020 · 3 generations on5descendants
- K183430Modular Spinal Fixation SystemLife Spine, Inc. · 2019 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K040583 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −15 | K041118 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −14 | K042025 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2004 | 4 |
| −13 | K043151 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −12 | K050809 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2005 | — |
| −11 | K052187 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −10 | K053101 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −9 | K091442 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2009 | — |
| −8 | K091974 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2009 | 1 |
| −7 | K102555 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2010 | — |
| −6 | K112473 | CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2011 | — |
| −5 | K113174 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2011 | 1 |
| −4 | K121680 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2012 | — |
| −3 | K131321 | CD Horizon Spinal System | Medtronic Sofamor Danek USA | 2013 | — |
| −2 | K132111 | CD Horizon Spinal System | Medtronic Sofamor Danek USA | 2013 | — |
| −1 | K132866 | Nautilus Spinal System | Life Spine, Inc. | 2013 | — |
| 0 (this device) | K141222 | Nautilus Spinal System and Solstice Oct System | Life Spine, Inc. | 2015 | — |
| +1 | K151196 | Nautilus Spinal System | Life Spine, Inc. | 2015 | — |
| +2 | K191575 | ARx Spinal System | Life Spine, Inc. | 2019 | — |
| +2 | K200070 | ARx Spinal System | Life Spine, Inc. | 2020 | — |
| +3 | K203163 | ARx Illiac Spinal Screw System | Life Spine, Inc. | 2020 | — |
| +2 | K183430 | Modular Spinal Fixation System | Life Spine, Inc. | 2019 | — |
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 | 8 | 0 |
| 1996 | 7 | 0 |
| 1997 | 7 | 0 |
| 1998 | 15 | 0 |
| 1999 | 13 | 0 |
| 2000 | 19 | 0 |
| 2001 | 22 | 0 |
| 2002 | 13 | 0 |
| 2003 | 20 | 0 |
| 2004 | 31 | 0 |
| 2005 | 23 | 0 |
| 2006 | 18 | 0 |
| 2007 | 22 | 0 |
| 2008 | 17 | 0 |
| 2009 | 12 | 0 |
| 2010 | 7 | 0 |
| 2011 | 6 | 0 |
| 2012 | 4 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 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.
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 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? (7)
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 |
|---|---|---|---|
| * | K090343 | Sentinel Spinal SystemSummary page 5…lass II MNI, CFR 888.3070, Class II KWP, CFR 888.3050, Class II Primary Predicate: Sentinel Spinal System (K090343) Additional Predicates: Theken Atoll OCT Spinal System (K083863) 5.5 Lumbar Cross Connector (K13286… | 2009 |
| * | K083863 | Theken Atoll Oct Spinal SystemSummary page 5…KWP, CFR 888.3050, Class II Primary Predicate: Sentinel Spinal System (K090343) Additional Predicates: Theken Atoll OCT Spinal System (K083863) 5.5 Lumbar Cross Connector (K132866) Globus Revere Addition System (K133350)… | 2009 |
| * | K132866 | Nautilus Spinal SystemSummary page 5…icate: Sentinel Spinal System (K090343) Additional Predicates: Theken Atoll OCT Spinal System (K083863) 5.5 Lumbar Cross Connector (K132866) Globus Revere Addition System (K133350) Coral Spinal System (K120047)… | 2013 |
| * | K133350 | Revere Stabilization SystemSummary page 5…ates: Theken Atoll OCT Spinal System (K083863) 5.5 Lumbar Cross Connector (K132866) Globus Revere Addition System (K133350) Coral Spinal System (K120047) Conquest Spinal System (K080767)… | 2014 |
| * | K120047 | Coral Spinal SystemSummary page 5…5.5 Lumbar Cross Connector (K132866) Globus Revere Addition System (K133350) Coral Spinal System (K120047) Conquest Spinal System (K080767) Nautilus Spinal System (K123373) Device De… | 2012 |
| * | K080767 | Conquest Spinal SystemSummary page 5…Globus Revere Addition System (K133350) Coral Spinal System (K120047) Conquest Spinal System (K080767) Nautilus Spinal System (K123373) Device Description: The NAUTILUS Thoracolumbar Spinal System consis… | 2008 |
| * | K123373 | Nautilus Spinal SystemSummary page 5…350) Coral Spinal System (K120047) Conquest Spinal System (K080767) Nautilus Spinal System (K123373) Device Description: The NAUTILUS Thoracolumbar Spinal System consists of an assortment of rods, screws, cross connectors, and… | 2013 |
What descends from it? (13)
See all 132 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 11 years and passes through 5 companies; a new generation was cleared every 4 months on median.
- 31 of the 300 ancestors have a recall of any class.
- Of its descendants, K151196 (Life Spine, Inc., 2015) has gone furthest, with 12 descendants of its own.
- 4 other devices also cite its predicate K090343.
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?
Nautilus Spinal System: 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…
Read the full statement (321 words)
Nautilus Spinal System:
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.
Solstice OCT System:
When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (Occiput – T3), the SOLSTICE OCT System, when properly used, is intended for: Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; spinal stenosis; fracture/dislocation; Atlanto/axial fracture with instability; occipitocervical dislocation; revision of previous cervical spine surgery; and tumors.
When used with occipital plate, the bone screws are limited to occipital fixation only. The bone screws are not intended to be used in the cervical spine.
The use of polyaxial screws is limited to placement in T1-T3 in treating thoracic conditions only. They are not intended to be placed in the cervical spine.
The hooks, rods, and connectors are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.
The Solstice OCT system can also be linked to the Conquest, Pilot, and Nautilus Spinal Systems through the use of transitional rods and rod connectors.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141222 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141222: Nautilus Spinal System and Solstice Oct System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141222
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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