510(k) Report

510(k) · Cleared

Cleared

Theken Coral Spinal System

K091266510(k) SpecialCleared Jun 10, 200941-day reviewClass II21 CFR 888.3070

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Theken Spine, LLC · NKB Thoracolumbosacral Pedicle Screw System

Cleared on Jun 10, 2009 as substantially equivalent to K041592 (Theken Surgical, 2004) and 4 other predicates after a 41-day review. Its family tree reaches back 4 generations to 1996. 15 later devices descend from it.

Decided
Jun 10, 2009
Review
41 days
Class
Class II
Product code
NKB
Recalls
None
Predicates
5

Its longest line of descent runs back 4 generations to K955348 (1996). 9 ancestors in all. 15 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2008: 1 other ancestor2007: 2 other ancestors2004: 1 other ancestor2000: 1 other ancestor2012: 1 descendant cleared2015: 2 descendants cleared2022: 2 descendants cleared2020: 2 descendants cleared2021: 2 descendants cleared2019: 2 descendants cleared2026: 2 descendants cleared2024: 1 descendant cleared2023: 1 descendant clearedK955348 · Titanium Moss Miami Spinal System · Depuy, Inc. · 1996K041592 · Coral Spinal System · Theken Surgical · 2004 · recalledK070962 · Coral Pedicle Screw System · Theken Spine, LLC · 2007K081414 · Modification to Coral Spinal System · Theken Spine, LLC · 20081995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 3 other ancestors 1 generation forward: 1 descendant2 generations forward: 1 descendant3 generations forward: 2 descendants4 generations forward: 4 descendants5 generations forward: 4 descendants6 generations forward: 2 descendants7 generations forward: 1 descendant K081414 · Modification to Coral Spinal System · Theken Spine, LLC · 2008K070962 · Coral Pedicle Screw System · Theken Spine, LLC · 2007K041592 · Coral Spinal System · Theken Surgical · 2004 · recalledK955348 · Titanium Moss Miami Spinal System · Depuy, Inc. · 19960+5
  1. Root · 4 generations backK955348 Titanium Moss Miami Spinal SystemDepuy, Inc. · 1996
  2. 3 generations backK041592 Coral Spinal SystemTheken Surgical · 2004 · Recalled
  3. 2 generations backK070962 Coral Pedicle Screw SystemTheken Spine, LLC · 2007
  4. 1 generation backK081414 Modification to Coral Spinal SystemTheken Spine, LLC · 2008
  5. This deviceK091266 Theken Coral Spinal SystemTheken Spine, LLC · 2009
  6. Descendant · cites it directly · 14 of its ownK120047 Coral Spinal SystemTheken Spine, LLC · 2012
  7. Descendant · 2 generations on · 13 of its ownK141222 Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc. · 2015
  8. Descendant · 3 generations on · 12 of its ownK151196 Nautilus Spinal SystemLife Spine, Inc. · 2015
  9. Descendant · 4 generations on · 10 of its ownK191575 ARx Spinal SystemLife Spine, Inc. · 2019
  10. Descendant · 4 generations on · 9 of its ownK200070 ARx Spinal SystemLife Spine, Inc. · 2020

Showing 5 of 15 descendants. See all descendants

Descendants cleared per year

2012: 12015: 22019: 22020: 22021: 22022: 22023: 12024: 12026: 2
2012high 2 (2015) · low 0 (2013)2026

Most influential descendants

Showing 5 of 15 · See all
  • 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
  • K200070ARx Spinal SystemLife Spine, Inc. · 2020 · 4 generations on9descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K955348Titanium Moss Miami Spinal SystemDepuy, Inc.1996—
−3K041592Coral Spinal SystemTheken Surgical20041
−2K070962Coral Pedicle Screw SystemTheken Spine, LLC2007—
−1K081414Modification to Coral Spinal SystemTheken Spine, LLC2008—
0 (this device)K091266Theken Coral Spinal SystemTheken Spine, LLC2009—
+1K120047Coral Spinal SystemTheken Spine, LLC2012—
+2K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc.2015—
+3K151196Nautilus Spinal SystemLife Spine, Inc.2015—
+4K191575ARx Spinal SystemLife Spine, Inc.2019—
+4K200070ARx Spinal SystemLife Spine, Inc.2020—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200010
200410
200720
200810

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201210
201520
201920
202020
202120
202220
202310
202410
202620
FIG. 1 — Lineage of K091266, 1996–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K223494 CD Horizon Spinal Systemscore 40.4 · 30 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K041592Coral Spinal System
Summary page 1
…Fixation Orthosis NKLB 888.3070 - Spondylolisthesis Spinal Fixation System Predicate Device: Theken Surgical Coral TM Spinal System, K04 1592 Theken Surgical Coral TM Spinal System, K070962 Theken Surgical Coral TM Sp…
Theken Surgical20041
*K070962Coral Pedicle Screw System
Summary page 1
…is Spinal Fixation System Predicate Device: Theken Surgical Coral TM Spinal System, K04 1592 Theken Surgical Coral TM Spinal System, K070962 Theken Surgical Coral TM Spinal System, K08 1414 K2M Range Spinal System, K…
Theken Spine, LLC2007—
*K081414Modification to Coral Spinal System
Summary page 1
…TM Spinal System, K04 1592 Theken Surgical Coral TM Spinal System, K070962 Theken Surgical Coral TM Spinal System, K08 1414 K2M Range Spinal System, K080792 Pioneer Surgical Quantum Spinal System, K0…
Theken Spine, LLC2008—
*K080792K2M Cocr Rod
Summary page 1
…Surgical Coral TM Spinal System, K070962 Theken Surgical Coral TM Spinal System, K08 1414 K2M Range Spinal System, K080792 Pioneer Surgical Quantum Spinal System, K07055 1 Device Description: The purpose of this submi…
K2m, Inc.2008—
*K070551Modification to: Pioneer Surgical Technology Quantum Spinal System
Summary page 1
…Surgical Coral TM Spinal System, K08 1414 K2M Range Spinal System, K080792 Pioneer Surgical Quantum Spinal System, K07055 1 Device Description: The purpose of this submission is the addition of cobalt chrome rods to th…
Pioneer Surgical Technology2007—

Also cleared against K041592: 7 other devices →

What descends from it? (15)

See all 15

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K120047Coral Spinal SystemTheken Spine, LLC201214

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 13 years and passes through 3 companies; a new generation was cleared every 2.9 years on median.
  • 3 of the 9 ancestors have a recall of any class.
  • Of its descendants, K120047 (Theken Spine, LLC, 2012) has gone furthest, with 14 descendants of its own.
  • 7 other devices also cite its predicate K041592.

How does its category compare?

All NKB devices

NKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · NKB

24in 2025

2007: 382008: 362009: 442010: 372011: 482012: 602013: 352014: 462015: 552016: 502017: 632018: 562019: 392020: 482021: 322022: 342023: 442024: 392025: 242026 (partial year): 30
2007high 63 (2017) · low 24 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NKB

61in 2025

2007: 87 days median2008: 59 days median2009: 71 days median2010: 111 days median2011: 84 days median2012: 79 days median2013: 73 days median2014: 90 days median2015: 90 days median2016: 84 days median2017: 69 days median2018: 61 days median2019: 84 days median2020: 68 days median2021: 61 days median2022: 88 days median2023: 72 days median2024: 57 days median2025: 61 days median2026 (partial year): 91 days median
2007high 111 (2010) · low 57 (2024)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · NKB

1in 2025

2007: 42008: 52009: 332010: 42011: 32012: 132014: 3, 1 Class I2015: 32016: 12017: 12018: 32019: 12020: 12022: 52023: 22024: 32025: 12026 (partial year): 3
2007high 33 (2009) · low 0 (2013)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · NKB

1,171in 2025

2007: 342008: 822009: 1712010: 4622011: 5772012: 1,7472013: 1,9622014: 1,6712015: 1,4462016: 1,5852017: 1,6182018: 1,6842019: 1,9152020: 2,0762021: 1,7452022: 1,3392023: 9192024: 1,6142025: 1,171
2007high 2,076 (2020) · low 34 (2007)2025

MAUDE reports naming product code NKB, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20073887434
20083659582
2009447133171
2010371114462
201148843577
20126079131,747
2013357301,962
201446903 (1)1,671
2015559031,446
2016508411,585
2017636911,618
2018566131,684
2019398411,915
2020486812,076
2021326101,745
2022348851,339
202344722919
2024395731,614
2025246111,171
202630913—

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.

Also cleared against K041592

7 other devices cite the same predicate.

  • K120047Coral Spinal SystemTheken Spine, LLC · 2012
  • K112759Apclo Pedicle Screw SystemsAtlas Spine, Inc. · 2011
  • K102204Choice Spine Starfire Pedicle Screw SystemChoicespine, LP · 2010
  • K100970Stainless Steel Spinal SystemTheken Spine, LLC · 2010
  • K081414Modification to Coral Spinal SystemTheken Spine, LLC · 2008
  • K072407Bodyform Thoracic Fixation SystemTheken Spine, LLC · 2007

More from Theken Spine, LLC

23 FDA decisions under this applicant name. See the company

  • K121482Instrument System for Endoscopic Spinal SurgeryTheken Spine, LLC · 2012
  • K121211VU Apod Intervertebral Body Fusion DeviceTheken Spine, LLC · 2012
  • K120829Stainless Steel Spinal SystemTheken Spine, LLC · 2012
  • K120047Coral Spinal SystemTheken Spine, LLC · 2012
  • K111675VU C*Pod Intervertebral Body Fusion DeviceTheken Spine, LLC · 2011

Recent decisions in NKB

The NKB category page

  • K261217AnyPlus II Spinal Fixation SystemGS Medical Co., Ltd. · 2026
  • K263062NOVIX Pedicle Screw SystemTdm Co., Ltd. · 2026
  • K262712Duet™ Spinal Fixation SystemDuet Spine Holdings, LLC · 2026
  • K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc. · 2026
  • K252139Kentrospine Viktr-MIS® Pedicle screw systemRivarp Medical Pvt., Ltd. · 2026

https://510kreport.com/device/K091266 · printed Nov 5, 2026

Cite this page

510(k) Report. “K091266: Theken Coral Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K091266

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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