510(k) · Cleared
Recalled · 2005Coral Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Theken Surgical · KWP Appliance, Fixation, Spinal Interlaminal
Cleared on Sep 16, 2004 as substantially equivalent to K991031 (Sofamor Danek USA,Inc., 2000) and 1 other predicate after a 94-day review. Its family tree reaches back 1 generation to 1996. 261 later devices descend from it. It has been recalled once.
- Decided
- Sep 16, 2004
- Review
- 94 days
- Class
- Class II
- Product code
- KWP
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 1 generation to K955348 (1996). 2 ancestors in all. 261 later devices descend from it, 8 citing it directly.
- Root · 1 generation backK955348 Titanium Moss Miami Spinal SystemDepuy, Inc. · 1996
- This deviceK041592 Coral Spinal SystemTheken Surgical · 2004
- Descendant · cites it directly · 118 of its ownK070962 Coral Pedicle Screw SystemTheken Spine, LLC · 2007
- Descendant · 2 generations on · 95 of its ownK110280 Revlok Fenestrated Screw SystemGlobus Medical, Inc. · 2011
- Descendant · cites it directly · 88 of its ownK102204 Choice Spine Starfire Pedicle Screw SystemChoicespine, LP · 2010
- Descendant · cites it directly · 87 of its ownK072407 Bodyform Thoracic Fixation SystemTheken Spine, LLC · 2007
- Descendant · 2 generations on · 82 of its ownK132049 Thunderbolt and Lancer Pedicle Screw SystemsChoicespine · 2014
Showing 5 of 261 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 261 · See all- K070962Coral Pedicle Screw SystemTheken Spine, LLC · 2007 · cites it directly118descendants
- K110280Revlok Fenestrated Screw SystemGlobus Medical, Inc. · 2011 · 2 generations on95descendants
- K102204Choice Spine Starfire Pedicle Screw SystemChoicespine, LP · 2010 · cites it directly88descendants
- K072407Bodyform Thoracic Fixation SystemTheken Spine, LLC · 2007 · cites it directly87descendants
- K132049Thunderbolt and Lancer Pedicle Screw SystemsChoicespine · 2014 · 2 generations on82descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K955348 | Titanium Moss Miami Spinal System | Depuy, Inc. | 1996 | — |
| 0 (this device) | K041592 | Coral Spinal System | Theken Surgical | 2004 | — |
| +1 | K070962 | Coral Pedicle Screw System | Theken Spine, LLC | 2007 | — |
| +2 | K110280 | Revlok Fenestrated Screw System | Globus Medical, Inc. | 2011 | — |
| +1 | K102204 | Choice Spine Starfire Pedicle Screw System | Choicespine, LP | 2010 | — |
| +1 | K072407 | Bodyform Thoracic Fixation System | Theken Spine, LLC | 2007 | — |
| +2 | K132049 | Thunderbolt and Lancer Pedicle Screw Systems | Choicespine | 2014 | — |
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 |
|---|---|---|
| 2007 | 2 | 0 |
| 2008 | 3 | 0 |
| 2009 | 3 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 3 | 0 |
| 2013 | 4 | 0 |
| 2014 | 4 | 0 |
| 2015 | 5 | 0 |
| 2016 | 5 | 0 |
| 2017 | 5 | 0 |
| 2018 | 11 | 0 |
| 2019 | 13 | 0 |
| 2020 | 15 | 0 |
| 2021 | 15 | 0 |
| 2022 | 22 | 0 |
| 2023 | 39 | 0 |
| 2024 | 37 | 0 |
| 2025 | 35 | 0 |
| 2026 | 36 | 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 KWP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K991031 | Colorado II Spinal SystemSummary page 1…xation Orthosis NKB 888.3060 - Spondylolisthesis Spinal Fixation System Predicate Device: Sofamor Danek Colorado 1I Spinal System, K991031 (et al) DePuy-Motech Moss Miami Spinal System, K955348 (et al) Device Description: The Coral… | 2000 |
| * | K955348 | Titanium Moss Miami Spinal SystemSummary page 1…Fixation System Predicate Device: Sofamor Danek Colorado 1I Spinal System, K991031 (et al) DePuy-Motech Moss Miami Spinal System, K955348 (et al) Device Description: The Coral TM Spinal System consists of a variety of shapes and sizes of… | 1996 |
What descends from it? (261)
See all 2618 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K070962 | Coral Pedicle Screw System | 2007 | 118 |
| K102204 | Choice Spine Starfire Pedicle Screw System | 2010 | 88 |
| K072407 | Bodyform Thoracic Fixation System | 2007 | 87 |
| K081414 | Modification to Coral Spinal System | 2008 | 21 |
| K091266 | Theken Coral Spinal System | 2009 | 15 |
| K120047 | Coral Spinal System | 2012 | 14 |
| K112759 | Apclo Pedicle Screw Systems | 2011 | 2 |
| K100970 | Stainless Steel Spinal System | 2010 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 4, 2005 | Not classified | Z-0183-06 | Other | The torque value of the device may increase over time. The increase could exceed the tolerance specification. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All KWP devicesKWP Appliance, Fixation, Spinal Interlaminal: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KWP
9in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · KWP
113in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWP
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWP
494in 2025
MAUDE reports naming product code KWP, 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 | 14 | 96 | 2 | 210 |
| 2008 | 13 | 50 | 1 | 594 |
| 2009 | 12 | 89 | 23 | 682 |
| 2010 | 14 | 186 | 2 | 474 |
| 2011 | 12 | 67 | 6 | 792 |
| 2012 | 18 | 112 | 1 | 918 |
| 2013 | 12 | 99 | 3 | 1,090 |
| 2014 | 13 | 138 | 0 | 1,022 |
| 2015 | 9 | 113 | 1 | 1,348 |
| 2016 | 0 | — | 3 | 1,379 |
| 2017 | 0 | — | 0 | 864 |
| 2018 | 0 | — | 1 | 657 |
| 2019 | 0 | — | 2 | 518 |
| 2020 | 0 | — | 0 | 796 |
| 2021 | 0 | — | 0 | 525 |
| 2022 | 0 | — | 2 | 335 |
| 2023 | 0 | — | 0 | 332 |
| 2024 | 0 | — | 0 | 436 |
| 2025 | 0 | — | 0 | 494 |
| 2026 | 0 | — | 0 | — |
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 for all of the following indications regardless of the intended use: degenerative disc disease (defined as discogenic back pain with degeneration of the…
Read the full statement (97 words)
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 for all of the following indications regardless of the intended use: 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/K041592 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041592: 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/K041592
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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