510(k) · Cleared
Clearedicotec Pedicle System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Icotec AG · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Apr 12, 2016 as substantially equivalent to K113058 (Corelink, LLC, 2012) and 1 other predicate after a 270-day review. Its family tree reaches back 12 generations to 1999. 30 later devices descend from it.
- Decided
- Apr 12, 2016
- Review
- 270 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 12 generations to K990745 (1999). 144 ancestors in all, the oldest K901587 (1990). 30 later devices descend from it, 4 citing it directly.
- Root · 12 generations backK990745 Modification to Synthes Universal Spinal SystemSynthes Spine · 1999
- 8 generations between
- 3 generations backK102488 Apex Spine System W/ Cocr RodsSpinecraft, LLC · 2010
- 2 generations backK110906 Apex Spine SystemSpinecraft, LLC · 2011
- 1 generation backK113058 Tiger Spine SystemCorelink, LLC · 2012
- This deviceK151977 icotec Pedicle SystemIcotec AG · 2016
- Descendant · cites it directly · 29 of its ownK190545 VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG · 2019 · Recalled
- Descendant · cites it directly · 27 of its ownK200596 G21 Cement, VADER® Pedicle SystemIcotec AG · 2020 · Recalled
- Descendant · 2 generations on · 14 of its ownK221926 Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc. · 2022
- Descendant · 3 generations on · 11 of its ownK232275 Invictus® Spinal Fixation SystemAlphatec Spine, Inc. · 2023
- Descendant · cites it directly · 6 of its ownK193423 VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG · 2020 · Recalled
Show all 12 generations
- Root · 12 generations backK990745 Modification to Synthes Universal Spinal SystemSynthes Spine · 1999
- 11 generations backK992739 Click'xSynthes Spine · 2000 · Recalled
- 10 generations backK040442 Protex Stabilization SystemGlobus Medical, Inc. · 2004
- 9 generations backK052069 Protex Stabilization System with Additional ComponentesGlobus Medical, Inc. · 2005
- 8 generations backK061202 Revere Stabilization SystemGlobus Medical, Inc. · 2006
- 7 generations backK081195 Revere Uniplanar ScrewsGlobus Medical, Inc. · 2008
- 6 generations backK091782 Revere 6.35 Stabilization SystemGlobus Medical, Inc. · 2009
- 5 generations backK093294 Revere Stabilization SystemGlobus Medical, Inc. · 2010
- 4 generations backK100788 Cocr RodsGlobus Medical, Inc. · 2010
- 3 generations backK102488 Apex Spine System W/ Cocr RodsSpinecraft, LLC · 2010
- 2 generations backK110906 Apex Spine SystemSpinecraft, LLC · 2011
- 1 generation backK113058 Tiger Spine SystemCorelink, LLC · 2012
- This deviceK151977 icotec Pedicle SystemIcotec AG · 2016
Showing 5 of 30 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 30 · See all- K190545VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG · 2019 · cites it directly29descendants
- K200596G21 Cement, VADER® Pedicle SystemIcotec AG · 2020 · cites it directly27descendants
- K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc. · 2022 · 2 generations on14descendants
- K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc. · 2023 · 3 generations on11descendants
- K193423VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG · 2020 · cites it directly6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K990745 | Modification to Synthes Universal Spinal System | Synthes Spine | 1999 | — |
| −11 | K992739 | Click'x | Synthes Spine | 2000 | 1 |
| −10 | K040442 | Protex Stabilization System | Globus Medical, Inc. | 2004 | — |
| −9 | K052069 | Protex Stabilization System with Additional Componentes | Globus Medical, Inc. | 2005 | — |
| −8 | K061202 | Revere Stabilization System | Globus Medical, Inc. | 2006 | — |
| −7 | K081195 | Revere Uniplanar Screws | Globus Medical, Inc. | 2008 | — |
| −6 | K091782 | Revere 6.35 Stabilization System | Globus Medical, Inc. | 2009 | — |
| −5 | K093294 | Revere Stabilization System | Globus Medical, Inc. | 2010 | — |
| −4 | K100788 | Cocr Rods | Globus Medical, Inc. | 2010 | — |
| −3 | K102488 | Apex Spine System W/ Cocr Rods | Spinecraft, LLC | 2010 | — |
| −2 | K110906 | Apex Spine System | Spinecraft, LLC | 2011 | — |
| −1 | K113058 | Tiger Spine System | Corelink, LLC | 2012 | — |
| 0 (this device) | K151977 | icotec Pedicle System | Icotec AG | 2016 | — |
| +1 | K190545 | VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0 | Icotec AG | 2019 | 1 |
| +1 | K200596 | G21 Cement, VADER® Pedicle System | Icotec AG | 2020 | 1 |
| +2 | K221926 | Invictus® Bone Cement, Invictus Spinal Fixation System | Alphatec Spine, Inc. | 2022 | — |
| +3 | K232275 | Invictus® Spinal Fixation System | Alphatec Spine, Inc. | 2023 | — |
| +1 | K193423 | VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0 | Icotec AG | 2020 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 2 | 0 |
| 1992 | 5 | 0 |
| 1993 | 2 | 0 |
| 1994 | 3 | 0 |
| 1995 | 5 | 0 |
| 1996 | 6 | 0 |
| 1997 | 6 | 0 |
| 1998 | 10 | 0 |
| 1999 | 6 | 0 |
| 2000 | 11 | 0 |
| 2001 | 8 | 0 |
| 2002 | 4 | 0 |
| 2003 | 10 | 0 |
| 2004 | 16 | 0 |
| 2005 | 8 | 0 |
| 2006 | 7 | 0 |
| 2007 | 6 | 0 |
| 2008 | 4 | 0 |
| 2009 | 6 | 0 |
| 2010 | 5 | 0 |
| 2011 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 7 | 0 |
| 2024 | 9 | 0 |
| 2025 | 5 | 0 |
| 2026 | 5 | 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 |
|---|---|---|---|
| * | K113058 | Tiger Spine SystemSummary page 4…edicle screw spinal system Class: III Product Code: NKB, MNI, MNH Primary Predicate: CoreLink Tiger Spine System (K113058) Additional Predicate: Amedica Valeo PS System (K072022) Indications for Use: The icotec Pedicle System is intended to… | 2012 |
| * | K072022 | Valeo Pedicle Screw Spinal SystemSummary page 4…oduct Code: NKB, MNI, MNH Primary Predicate: CoreLink Tiger Spine System (K113058) Additional Predicate: Amedica Valeo PS System (K072022) Indications for Use: The icotec Pedicle System is intended to provide immobilization and stabilization of the posterior, non- c… | 2007 |
What descends from it? (30)
See all 304 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 17 years and passes through 5 companies; a new generation was cleared every 11 months on median.
- 10 of the 144 ancestors have a recall of any class.
- Of its descendants, K190545 (Icotec AG, 2019) has gone furthest, with 29 descendants of its own.
- 8 other devices also cite its predicate K113058.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 icotec Pedicle System is intended to provide immobilization and stabilization of the posterior, noncervical spine in
skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (DDD) (defined
as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies);
spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; 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/K151977 · printed Nov 4, 2026
Cite this page
510(k) Report. “K151977: icotec Pedicle System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K151977
Report an extraction error
Are you the manufacturer?
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