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 Oct 3, 2013 as substantially equivalent to K123373 (Life Spine, 2013) after a 29-day review. Its family tree reaches back 13 generations to 1985. 14 later devices descend from it.
- Decided
- Oct 3, 2013
- Review
- 29 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 13 generations to K853033 (1985). 143 ancestors in all. 14 later devices descend from it, 2 citing it directly.
- Root · 13 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 9 generations between
- 3 generations backK073430 Valeo Pedicle Screw Spinal SystemAmedica Corp. · 2008
- 2 generations backK080767 Conquest Spinal SystemLife Spine · 2008
- 1 generation backK123373 Nautilus Spinal SystemLife Spine · 2013
- This deviceK132760 Nautilus Spinal SystemLife Spine, Inc. · 2013
- Descendant · cites it directly · 13 of its ownK133564 Modification to Nautilus Spinal SystemLife Spine, LLC · 2014
- Descendant · 2 generations on · 10 of its ownK191575 ARx Spinal SystemLife Spine, Inc. · 2019
- Descendant · 3 generations on · 9 of its ownK200070 ARx Spinal SystemLife Spine, Inc. · 2020
- Descendant · 4 generations on · 5 of its ownK203163 ARx Illiac Spinal Screw SystemLife Spine, Inc. · 2020
- Descendant · 2 generations on · 3 of its ownK140457 Nautilus Spinal SystemLife Spine, Inc. · 2014
Show all 13 generations
- Root · 13 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 12 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
- 11 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
- 10 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
- 9 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
- 8 generations backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
- 7 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
- 6 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
- 5 generations backK062174 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 4 generations backK070387 Expedium Spine SystemDepuy Spine, Inc. · 2007
- 3 generations backK073430 Valeo Pedicle Screw Spinal SystemAmedica Corp. · 2008
- 2 generations backK080767 Conquest Spinal SystemLife Spine · 2008
- 1 generation backK123373 Nautilus Spinal SystemLife Spine · 2013
- This deviceK132760 Nautilus Spinal SystemLife Spine, Inc. · 2013
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K133564Modification to Nautilus Spinal SystemLife Spine, LLC · 2014 · cites it directly13descendants
- K191575ARx Spinal SystemLife Spine, Inc. · 2019 · 2 generations on10descendants
- K200070ARx Spinal SystemLife Spine, Inc. · 2020 · 3 generations on9descendants
- K203163ARx Illiac Spinal Screw SystemLife Spine, Inc. · 2020 · 4 generations on5descendants
- K140457Nautilus Spinal SystemLife Spine, Inc. · 2014 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K853033 | Hartshill Rect & Wires, Spinal Fixation System | A.W. Showell (Surgicraft), Ltd. | 1985 | — |
| −12 | K965221 | Ransford Cervical Fixation System | Surgicraft, Ltd. | 1997 | — |
| −11 | K982322 | Synthes Spine Occipital-Cervical Plate/Rod and Hook System | Synthes (Usa) | 1998 | — |
| −10 | K002733 | Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2000 | — |
| −9 | K013222 | Summit Occipito-Cervico- Thoracic (Oct) Spinal System | Depuyacromed | 2001 | — |
| −8 | K022190 | Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2002 | — |
| −7 | K030103 | Summit Oct Spinal System Minipolyaxial Screws | Depuyacromed | 2003 | — |
| −6 | K041203 | Summit Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
| −5 | K062174 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| −4 | K070387 | Expedium Spine System | Depuy Spine, Inc. | 2007 | — |
| −3 | K073430 | Valeo Pedicle Screw Spinal System | Amedica Corp. | 2008 | — |
| −2 | K080767 | Conquest Spinal System | Life Spine | 2008 | — |
| −1 | K123373 | Nautilus Spinal System | Life Spine | 2013 | — |
| 0 (this device) | K132760 | Nautilus Spinal System | Life Spine, Inc. | 2013 | — |
| +1 | K133564 | Modification to Nautilus Spinal System | Life Spine, LLC | 2014 | — |
| +2 | K191575 | ARx Spinal System | Life Spine, Inc. | 2019 | — |
| +3 | K200070 | ARx Spinal System | Life Spine, Inc. | 2020 | — |
| +4 | K203163 | ARx Illiac Spinal Screw System | Life Spine, Inc. | 2020 | — |
| +2 | K140457 | Nautilus Spinal System | Life Spine, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 2 | 0 |
| 1992 | 5 | 0 |
| 1993 | 3 | 0 |
| 1994 | 3 | 0 |
| 1995 | 7 | 0 |
| 1996 | 4 | 0 |
| 1997 | 4 | 0 |
| 1998 | 11 | 0 |
| 1999 | 11 | 0 |
| 2000 | 10 | 0 |
| 2001 | 9 | 0 |
| 2002 | 8 | 0 |
| 2003 | 13 | 0 |
| 2004 | 16 | 0 |
| 2005 | 10 | 0 |
| 2006 | 6 | 0 |
| 2007 | 8 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 2 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K123373 | Nautilus Spinal SystemSummary page 1…, Class III MNH. CFR 888.3070, Class 11 MN. CER 888.3070, Class 11 Predicate Device: NAUTILUS Spinal System (K 123373) Device Description: The NAUTILUS Thoracolumbar Spinal System consists of an assortment of rods, screws, cross connectors, a… | 2013 |
What descends from it? (14)
See all 142 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 28 years and passes through 8 companies; a new generation was cleared every 11 months on median.
- 13 of the 143 ancestors have a recall of any class.
- Of its descendants, K133564 (Life Spine, LLC, 2014) has gone furthest, with 13 descendants of its own.
- 2 other devices also cite its predicate K123373.
How does its category compare?
All NKB devicesNKB 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
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 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.
https://510kreport.com/device/K132760 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132760: 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/K132760
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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