510(k) · Cleared
ClearedCoral Pedicle Screw 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 Aug 22, 2007 as substantially equivalent to K041592 (Theken Surgical, 2004) after a 139-day review. Its family tree reaches back 2 generations to 1996. 118 later devices descend from it.
- Decided
- Aug 22, 2007
- Review
- 139 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K955348 (1996). 3 ancestors in all. 118 later devices descend from it, 6 citing it directly.
- Root · 2 generations backK955348 Titanium Moss Miami Spinal SystemDepuy, Inc. · 1996
- 1 generation backK041592 Coral Spinal SystemTheken Surgical · 2004 · Recalled
- This deviceK070962 Coral Pedicle Screw SystemTheken Spine, LLC · 2007
- Descendant · cites it directly · 95 of its ownK110280 Revlok Fenestrated Screw SystemGlobus Medical, Inc. · 2011
- Descendant · 2 generations on · 67 of its ownK160989 NuVasive® Reline® SystemNu Vasive, Incorporated · 2016
- Descendant · 3 generations on · 41 of its ownK180498 NuVasive Reline Fenestrated Screws, High V+ Bone CementNu Vasive, Incorporated · 2018
- Descendant · 3 generations on · 39 of its ownK170126 NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated · 2017
- Descendant · 4 generations on · 28 of its ownK190526 High V+ Bone Cement, CarboClear® Fenestrated Pedicle ScrewsCarboFix Orthopedics, Ltd. · 2019
Showing 5 of 118 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 118 · See all- K110280Revlok Fenestrated Screw SystemGlobus Medical, Inc. · 2011 · cites it directly95descendants
- K160989NuVasive® Reline® SystemNu Vasive, Incorporated · 2016 · 2 generations on67descendants
- K180498NuVasive Reline Fenestrated Screws, High V+ Bone CementNu Vasive, Incorporated · 2018 · 3 generations on41descendants
- K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated · 2017 · 3 generations on39descendants
- K190526High V+ Bone Cement, CarboClear® Fenestrated Pedicle ScrewsCarboFix Orthopedics, Ltd. · 2019 · 4 generations on28descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K955348 | Titanium Moss Miami Spinal System | Depuy, Inc. | 1996 | — |
| −1 | K041592 | Coral Spinal System | Theken Surgical | 2004 | 1 |
| 0 (this device) | K070962 | Coral Pedicle Screw System | Theken Spine, LLC | 2007 | — |
| +1 | K110280 | Revlok Fenestrated Screw System | Globus Medical, Inc. | 2011 | — |
| +2 | K160989 | NuVasive® Reline® System | Nu Vasive, Incorporated | 2016 | — |
| +3 | K180498 | NuVasive Reline Fenestrated Screws, High V+ Bone Cement | Nu Vasive, Incorporated | 2018 | — |
| +3 | K170126 | NuVasive® Reline® 4.5-5.0 System | Nu Vasive, Incorporated | 2017 | — |
| +4 | K190526 | High V+ Bone Cement, CarboClear® Fenestrated Pedicle Screws | CarboFix Orthopedics, Ltd. | 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 |
|---|---|---|
| 2008 | 3 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 3 | 0 |
| 2013 | 3 | 0 |
| 2014 | 3 | 0 |
| 2015 | 3 | 0 |
| 2016 | 4 | 0 |
| 2017 | 2 | 0 |
| 2018 | 5 | 0 |
| 2019 | 7 | 0 |
| 2020 | 7 | 0 |
| 2021 | 7 | 0 |
| 2022 | 6 | 0 |
| 2023 | 17 | 0 |
| 2024 | 15 | 0 |
| 2025 | 12 | 0 |
| 2026 | 16 | 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 |
|---|---|---|---|
| * | K041592 | Coral Spinal SystemSummary page 1…Fixation Orthosis NKB 888.3060 - Spondylolisthesis Spinal Fixation System Predicate Device: Theken Surgical Coral TM Spinal System, K041592 Comparative Devices: Sofamor Danek Colorado 1i Spinal System, K991031 (et al) DePuy-Motech Moss… | 2004 |
| † | K991031 | Colorado II Spinal System | 2000 |
| † | K955348 | Titanium Moss Miami Spinal System | 1996 |
| † | K052385 | Tangors Polyaxial System | 2005 |
What descends from it? (118)
See all 1186 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 3 companies; a new generation was cleared every 8.6 years on median.
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K110280 (Globus Medical, Inc., 2011) has gone furthest, with 95 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. 2007, 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 Coral T M 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/K070962 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070962: Coral Pedicle Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070962
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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