510(k) · Cleared
ClearedApex Spine System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spinecraft, LLC · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Jul 26, 2011 as substantially equivalent to K062513 (Spinecraft, Inc., 2006) and 8 other predicates after a 117-day review. Its family tree reaches back 10 generations to 1999. 103 later devices descend from it.
- Decided
- Jul 26, 2011
- Review
- 117 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 9
Its longest line of descent runs back 10 generations to K990745 (1999). 110 ancestors in all, the oldest K901587 (1990). 103 later devices descend from it, 3 citing it directly.
- Root · 10 generations backK990745 Modification to Synthes Universal Spinal SystemSynthes Spine · 1999
- 6 generations between
- 3 generations backK093294 Revere Stabilization SystemGlobus Medical, Inc. · 2010
- 2 generations backK100788 Cocr RodsGlobus Medical, Inc. · 2010
- 1 generation backK102488 Apex Spine System W/ Cocr RodsSpinecraft, LLC · 2010
- This deviceK110906 Apex Spine SystemSpinecraft, LLC · 2011
- Descendant · cites it directly · 81 of its ownK113058 Tiger Spine SystemCorelink, LLC · 2012
- Descendant · 2 generations on · 40 of its ownK131250 Tiger Spine SystemCorelink, LLC · 2013
- Descendant · 2 generations on · 30 of its ownK151977 icotec Pedicle SystemIcotec AG · 2016
- Descendant · 2 generations on · 29 of its ownK190545 VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG · 2019 · Recalled
- Descendant · 3 generations on · 29 of its ownK133369 Tiger Spine SystemCorelink, LLC · 2014
Show all 10 generations
- Root · 10 generations backK990745 Modification to Synthes Universal Spinal SystemSynthes Spine · 1999
- 9 generations backK992739 Click'xSynthes Spine · 2000 · Recalled
- 8 generations backK040442 Protex Stabilization SystemGlobus Medical, Inc. · 2004
- 7 generations backK052069 Protex Stabilization System with Additional ComponentesGlobus Medical, Inc. · 2005
- 6 generations backK061202 Revere Stabilization SystemGlobus Medical, Inc. · 2006
- 5 generations backK081195 Revere Uniplanar ScrewsGlobus Medical, Inc. · 2008
- 4 generations backK091782 Revere 6.35 Stabilization SystemGlobus Medical, Inc. · 2009
- 3 generations backK093294 Revere Stabilization SystemGlobus Medical, Inc. · 2010
- 2 generations backK100788 Cocr RodsGlobus Medical, Inc. · 2010
- 1 generation backK102488 Apex Spine System W/ Cocr RodsSpinecraft, LLC · 2010
- This deviceK110906 Apex Spine SystemSpinecraft, LLC · 2011
Showing 5 of 103 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 103 · See all- K113058Tiger Spine SystemCorelink, LLC · 2012 · cites it directly81descendants
- K131250Tiger Spine SystemCorelink, LLC · 2013 · 2 generations on40descendants
- K151977icotec Pedicle SystemIcotec AG · 2016 · 2 generations on30descendants
- K190545VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG · 2019 · 2 generations on29descendants
- K133369Tiger Spine SystemCorelink, LLC · 2014 · 3 generations on29descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K990745 | Modification to Synthes Universal Spinal System | Synthes Spine | 1999 | — |
| −9 | K992739 | Click'x | Synthes Spine | 2000 | 1 |
| −8 | K040442 | Protex Stabilization System | Globus Medical, Inc. | 2004 | — |
| −7 | K052069 | Protex Stabilization System with Additional Componentes | Globus Medical, Inc. | 2005 | — |
| −6 | K061202 | Revere Stabilization System | Globus Medical, Inc. | 2006 | — |
| −5 | K081195 | Revere Uniplanar Screws | Globus Medical, Inc. | 2008 | — |
| −4 | K091782 | Revere 6.35 Stabilization System | Globus Medical, Inc. | 2009 | — |
| −3 | K093294 | Revere Stabilization System | Globus Medical, Inc. | 2010 | — |
| −2 | K100788 | Cocr Rods | Globus Medical, Inc. | 2010 | — |
| −1 | K102488 | Apex Spine System W/ Cocr Rods | Spinecraft, LLC | 2010 | — |
| 0 (this device) | K110906 | Apex Spine System | Spinecraft, LLC | 2011 | — |
| +1 | K113058 | Tiger Spine System | Corelink, LLC | 2012 | — |
| +2 | K131250 | Tiger Spine System | Corelink, LLC | 2013 | — |
| +2 | K151977 | icotec Pedicle System | Icotec AG | 2016 | — |
| +2 | K190545 | VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0 | Icotec AG | 2019 | 1 |
| +3 | K133369 | Tiger Spine System | Corelink, LLC | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 2 | 0 |
| 1992 | 5 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 4 | 0 |
| 1996 | 3 | 0 |
| 1997 | 3 | 0 |
| 1998 | 5 | 0 |
| 1999 | 2 | 0 |
| 2000 | 8 | 0 |
| 2001 | 7 | 0 |
| 2002 | 2 | 0 |
| 2003 | 7 | 0 |
| 2004 | 13 | 0 |
| 2005 | 8 | 0 |
| 2006 | 7 | 0 |
| 2007 | 4 | 0 |
| 2008 | 4 | 0 |
| 2009 | 6 | 0 |
| 2010 | 5 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 2 | 0 |
| 2013 | 3 | 0 |
| 2014 | 2 | 0 |
| 2015 | 5 | 0 |
| 2016 | 3 | 0 |
| 2017 | 4 | 0 |
| 2018 | 5 | 0 |
| 2019 | 5 | 0 |
| 2020 | 6 | 0 |
| 2021 | 4 | 0 |
| 2022 | 7 | 0 |
| 2023 | 13 | 0 |
| 2024 | 18 | 0 |
| 2025 | 16 | 0 |
| 2026 | 10 | 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? (9)
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 |
|---|---|---|---|
| * | K062513 | Apex Spine SystemSummary page 1…l Classification Panel: Orthopedics 3. Predicate or legally marketed devices which are substantially equivalent: * APEX Spine System (K062513/I K092825/IK102488) I SpineCraft * Viper Spine System (K090648/I K102701) / DePuy Spine * Polaris S… | 2006 |
| * | K092825 | Apex Spine System 5.50 MM Titanium Rod & Polyaxial Screw WasherSummary page 1…Classification Panel: Orthopedics 3. Predicate or legally marketed devices which are substantially equivalent: * APEX Spine System (K062513/I K092825/IK102488) I SpineCraft * Viper Spine System (K090648/I K102701) / DePuy Spine * Polaris Spinal Syst… | 2010 |
| * | K102488 | Apex Spine System W/ Cocr RodsSummary page 1…fication Panel: Orthopedics 3. Predicate or legally marketed devices which are substantially equivalent: * APEX Spine System (K062513/I K092825/IK102488) I SpineCraft * Viper Spine System (K090648/I K102701) / DePuy Spine * Polaris Spinal System (K1033… | 2010 |
| * | K090648 | Viper 2 SystemSummary page 1…y marketed devices which are substantially equivalent: * APEX Spine System (K062513/I K092825/IK102488) I SpineCraft * Viper Spine System (K090648/I K102701) / DePuy Spine * Polaris Spinal System (K103393 / K100409 / K100438) / BIOMET Spine/ EBI, L.P.… | 2009 |
| * | K102701 | Viper Spine SystemSummary page 1…devices which are substantially equivalent: * APEX Spine System (K062513/I K092825/IK102488) I SpineCraft * Viper Spine System (K090648/I K102701) / DePuy Spine * Polaris Spinal System (K103393 / K100409 / K100438) / BIOMET Spine/ EBI, L.P. " Sy… | 2010 |
| * | K103393 | Polaris Spinal SystemSummary page 1…APEX Spine System (K062513/I K092825/IK102488) I SpineCraft * Viper Spine System (K090648/I K102701) / DePuy Spine * Polaris Spinal System (K103393 / K100409 / K100438) / BIOMET Spine/ EBI, L.P. " Synthes Pangea System (K052123) / Synthes Spine 4. Descript… | 2011 |
| * | K100409 | Polaris Spinal System, Polaris/Synergy Structue Anterior Fixation SystemSummary page 1…System (K062513/I K092825/IK102488) I SpineCraft * Viper Spine System (K090648/I K102701) / DePuy Spine * Polaris Spinal System (K103393 / K100409 / K100438) / BIOMET Spine/ EBI, L.P. " Synthes Pangea System (K052123) / Synthes Spine 4. Description of the… | 2010 |
| * | K100438 | Polaris Spinal System, Polaris/Synergy Structure Anterior Fixation SystemSummary page 1…062513/I K092825/IK102488) I SpineCraft * Viper Spine System (K090648/I K102701) / DePuy Spine * Polaris Spinal System (K103393 / K100409 / K100438) / BIOMET Spine/ EBI, L.P. " Synthes Pangea System (K052123) / Synthes Spine 4. Description of the device:… | 2010 |
| * | K052123 | Synthes Pangea SystemSummary page 1…(K090648/I K102701) / DePuy Spine * Polaris Spinal System (K103393 / K100409 / K100438) / BIOMET Spine/ EBI, L.P. " Synthes Pangea System (K052123) / Synthes Spine 4. Description of the device: The purpose of this submission is to add cannulated screws to… | 2005 |
What descends from it? (103)
See all 1033 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 12 years and passes through 3 companies; a new generation was cleared every 11 months on median.
- 6 of the 110 ancestors have a recall of any class.
- Of its descendants, K113058 (Corelink, LLC, 2012) has gone furthest, with 81 descendants of its own.
- 7 other devices also cite its predicate K062513.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 APEX Spine System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-Sl vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis…
Read the full statement (276 words)
The APEX Spine System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-Sl vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudoarthrosis).
The APEX Spine System is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-Sl vertebra in skeletally mature patients receiving fusion by autogenous bone graft, with the device fixed or attached to the lumbar and sacral spine (levels of pedicle screw fixation are L3 to Si), and for whom the device is intended to be removed after solid fusion is attained.
The APEX Spine System is also a sacral/iliac screw fixation system of the non-cervical spine indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudo-arthrosis).
When used in a percutaneous, posterior approach with AIM Spine MIS instrumentation, the APEX Spine System is intended for non-cervical pedicle fixation 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, curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion in skeletally mature patients. Levels of fixation are for the thoracic, lumbar and sacral spine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110906 · printed Nov 4, 2026
Cite this page
510(k) Report. “K110906: Apex Spine System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K110906
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