510(k) · Cleared
ClearedModification to Coral Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Theken Spine, LLC · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Jun 17, 2008 as substantially equivalent to K041592 (Theken Surgical, 2004) and 1 other predicate after a 28-day review. Its family tree reaches back 3 generations to 1996. 21 later devices descend from it.
- Decided
- Jun 17, 2008
- Review
- 28 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K955348 (1996). 4 ancestors in all. 21 later devices descend from it, 4 citing it directly.
- Root · 3 generations backK955348 Titanium Moss Miami Spinal SystemDepuy, Inc. · 1996
- 2 generations backK041592 Coral Spinal SystemTheken Surgical · 2004 · Recalled
- 1 generation backK070962 Coral Pedicle Screw SystemTheken Spine, LLC · 2007
- This deviceK081414 Modification to Coral Spinal SystemTheken Spine, LLC · 2008
- Descendant · cites it directly · 15 of its ownK091266 Theken Coral Spinal SystemTheken Spine, LLC · 2009
- Descendant · cites it directly · 14 of its ownK120047 Coral Spinal SystemTheken Spine, LLC · 2012
- Descendant · 2 generations on · 13 of its ownK141222 Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc. · 2015
- Descendant · 3 generations on · 12 of its ownK151196 Nautilus Spinal SystemLife Spine, Inc. · 2015
- Descendant · 4 generations on · 10 of its ownK191575 ARx Spinal SystemLife Spine, Inc. · 2019
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K091266Theken Coral Spinal SystemTheken Spine, LLC · 2009 · cites it directly15descendants
- K120047Coral Spinal SystemTheken Spine, LLC · 2012 · cites it directly14descendants
- K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc. · 2015 · 2 generations on13descendants
- K151196Nautilus Spinal SystemLife Spine, Inc. · 2015 · 3 generations on12descendants
- K191575ARx Spinal SystemLife Spine, Inc. · 2019 · 4 generations on10descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K955348 | Titanium Moss Miami Spinal System | Depuy, Inc. | 1996 | — |
| −2 | K041592 | Coral Spinal System | Theken Surgical | 2004 | 1 |
| −1 | K070962 | Coral Pedicle Screw System | Theken Spine, LLC | 2007 | — |
| 0 (this device) | K081414 | Modification to Coral Spinal System | Theken Spine, LLC | 2008 | — |
| +1 | K091266 | Theken Coral Spinal System | Theken Spine, LLC | 2009 | — |
| +1 | K120047 | Coral Spinal System | Theken Spine, LLC | 2012 | — |
| +2 | K141222 | Nautilus Spinal System and Solstice Oct System | Life Spine, Inc. | 2015 | — |
| +3 | K151196 | Nautilus Spinal System | Life Spine, Inc. | 2015 | — |
| +4 | K191575 | ARx Spinal System | Life Spine, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2015 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 3 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K041592 | Coral Spinal SystemSummary page 1…l Fixation Orthosis NKB 888.3070 - Spondylolisthesis Spinal Fixation System Predicate Device: Theken Surgical CoralTM Spinal System, K041592 Theken Surgical CoralTM Spinal System, K070962 Device Description: The purpose of this submiss… | 2004 |
| * | K070962 | Coral Pedicle Screw SystemSummary page 1…hesis Spinal Fixation System Predicate Device: Theken Surgical CoralTM Spinal System, K041592 Theken Surgical CoralTM Spinal System, K070962 Device Description: The purpose of this submission is to add rod to rod connectors and lateral… | 2007 |
What descends from it? (21)
See all 214 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 12 years and passes through 3 companies; a new generation was cleared every 2.9 years on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K091266 (Theken Spine, LLC, 2009) has gone furthest, with 15 descendants of its own.
- 7 other devices also cite its predicate K041592.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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?
The CoralTM Spinal System is a non-cervical spinal fixation device intended for use as a posterior pedicle screw fixation system, a posterior non-pedicle screw fixation system, or as an anterolateral fixation system. Pedicle screw fixation is limited to skeletally mature patients. The device is indicated as an adjunct to fusion for the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081414 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081414: Modification to Coral 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/K081414
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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