510(k) · Cleared
ClearedCoral 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 Feb 3, 2012 as substantially equivalent to K070962 (Theken Spine, LLC, 2007) and 4 other predicates after a 28-day review. Its family tree reaches back 10 generations to 1990. 14 later devices descend from it.
- Decided
- Feb 3, 2012
- Review
- 28 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 10 generations to K901587 (1990). 39 ancestors in all. 14 later devices descend from it, 1 citing it directly.
- Root · 10 generations backK901587 TSRH Sacral L-ConnectorDanek Medical, Inc. · 1990
- 6 generations between
- 3 generations backK043232 Ucr Spinal SystemSeaspine · 2004 · Recalled
- 2 generations backK051663 Malibu Spinal SystemSeaspine, Inc. · 2005
- 1 generation backK061342 Malibu Spinal SystemSeaspine, Inc. · 2006 · Recalled
- This deviceK120047 Coral Spinal SystemTheken Spine, LLC · 2012
- Descendant · cites it directly · 13 of its ownK141222 Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc. · 2015
- Descendant · 2 generations on · 12 of its ownK151196 Nautilus Spinal SystemLife Spine, Inc. · 2015
- Descendant · 3 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
Show all 10 generations
- Root · 10 generations backK901587 TSRH Sacral L-ConnectorDanek Medical, Inc. · 1990
- 9 generations backK950099 Synergy (TM) TI Posterior Spinal SystemBuckman Co., Inc. · 1997
- 8 generations backK973836 Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the…Cross Medical Products, Inc. · 1998
- 7 generations backK974749 Synergy Closed Variable Locking Screw (VLS), Part of the Cross…Cross Medical Products, Inc. · 1998
- 6 generations backK993503 Haider-Ucr Spinal SystemInternational Advanced Medical Enterprises, Inc. · 2000
- 5 generations backK021623 Ucr Spinal System, 5.5MM, 8.0MM Screws & InstrumentsIame, Inc. · 2002
- 4 generations backK032739 Ucr Spinal SystemSeaspine · 2003
- 3 generations backK043232 Ucr Spinal SystemSeaspine · 2004 · Recalled
- 2 generations backK051663 Malibu Spinal SystemSeaspine, Inc. · 2005
- 1 generation backK061342 Malibu Spinal SystemSeaspine, Inc. · 2006 · Recalled
- This deviceK120047 Coral Spinal SystemTheken Spine, LLC · 2012
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · 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
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K901587 | TSRH Sacral L-Connector | Danek Medical, Inc. | 1990 | — |
| −9 | K950099 | Synergy (TM) TI Posterior Spinal System | Buckman Co., Inc. | 1997 | — |
| −8 | K973836 | Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the Cross… | Cross Medical Products, Inc. | 1998 | — |
| −7 | K974749 | Synergy Closed Variable Locking Screw (VLS), Part of the Cross Medical-Synergy… | Cross Medical Products, Inc. | 1998 | — |
| −6 | K993503 | Haider-Ucr Spinal System | International Advanced Medical Enterprises, Inc. | 2000 | — |
| −5 | K021623 | Ucr Spinal System, 5.5MM, 8.0MM Screws & Instruments | Iame, Inc. | 2002 | — |
| −4 | K032739 | Ucr Spinal System | Seaspine | 2003 | — |
| −3 | K043232 | Ucr Spinal System | Seaspine | 2004 | 1 |
| −2 | K051663 | Malibu Spinal System | Seaspine, Inc. | 2005 | — |
| −1 | K061342 | Malibu Spinal System | Seaspine, Inc. | 2006 | 1 |
| 0 (this device) | K120047 | Coral Spinal System | Theken Spine, LLC | 2012 | — |
| +1 | K141222 | Nautilus Spinal System and Solstice Oct System | Life Spine, Inc. | 2015 | — |
| +2 | K151196 | Nautilus Spinal System | Life Spine, Inc. | 2015 | — |
| +3 | 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 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1992 | 5 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2007 | 3 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 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? (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 |
|---|---|---|---|
| * | K070962 | Coral Pedicle Screw SystemSummary page 1…aminal Fixation Orthosis NKB 888.3070 - Spondylolisthesis Spinal Fixation System Predicate Device: Theken Surgical CoraI TM Spinal System, K070962, K08 1414, K091266, K04 1592 SeaSpine, Inc. Malibu Spinal System, K061342 Device… | 2007 |
| * | K081414 | Modification to Coral Spinal SystemSummary page 1…xation Orthosis NKB 888.3070 - Spondylolisthesis Spinal Fixation System Predicate Device: Theken Surgical CoraI TM Spinal System, K070962, K08 1414, K091266, K04 1592 SeaSpine, Inc. Malibu Spinal System, K061342 Device Descripti… | 2008 |
| * | K091266 | Theken Coral Spinal SystemSummary page 1…hosis NKB 888.3070 - Spondylolisthesis Spinal Fixation System Predicate Device: Theken Surgical CoraI TM Spinal System, K070962, K08 1414, K091266, K04 1592 SeaSpine, Inc. Malibu Spinal System, K061342 Device Description: T… | 2009 |
| * | K041592 | Coral Spinal SystemSummary page 1…888.3070 - Spondylolisthesis Spinal Fixation System Predicate Device: Theken Surgical CoraI TM Spinal System, K070962, K08 1414, K091266, K04 1592 SeaSpine, Inc. Malibu Spinal System, K061342 Device Description: The purpose of this submission is t… | 2004 |
| * | K061342 | Malibu Spinal SystemSummary page 1…: Theken Surgical CoraI TM Spinal System, K070962, K08 1414, K091266, K04 1592 SeaSpine, Inc. Malibu Spinal System, K061342 Device Description: The purpose of this submission is the addition of the Malibu adjustable cross co… | 2006 |
What descends from it? (14)
See all 141 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K141222 | Nautilus Spinal System and Solstice Oct System | 2015 | 13 |
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 22 years and passes through 8 companies; a new generation was cleared every 1.3 years on median.
- 6 of the 39 ancestors have a recall of any class.
- Of its descendants, K141222 (Life Spine, Inc., 2015) has gone furthest, with 13 descendants of its own.
- 5 other devices also cite its predicate K070962.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 CoralT 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/K120047 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120047: 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/K120047
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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