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 Nov 20, 2013 as substantially equivalent to K062513 (Spinecraft, Inc., 2006) and 10 other predicates after a 92-day review. Its family tree reaches back 11 generations to 1999. 25 later devices descend from it.
- Decided
- Nov 20, 2013
- Review
- 92 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 12
Its longest line of descent runs back 11 generations to K990745 (1999). 165 ancestors in all, the oldest K781443 (1978). 25 later devices descend from it, 2 citing it directly.
- Root · 11 generations backK990745 Modification to Synthes Universal Spinal SystemSynthes Spine · 1999
- 7 generations between
- 3 generations backK100788 Cocr RodsGlobus Medical, Inc. · 2010
- 2 generations backK102488 Apex Spine System W/ Cocr RodsSpinecraft, LLC · 2010
- 1 generation backK110906 Apex Spine SystemSpinecraft, LLC · 2011
- This deviceK132603 Apex Spine SystemSpinecraft, LLC · 2013
- Descendant · cites it directly · 21 of its ownK150417 Astra Spine SystemSpinecraft, LLC · 2015
- Descendant · 2 generations on · 12 of its ownK211323 ASTRA Spine SystemSpinecraft, LLC · 2021
- Descendant · 2 generations on · 8 of its ownK223273 ASTRA Spine SystemSpinecraft, LLC · 2022
- Descendant · 2 generations on · 6 of its ownK162786 PASS LP Spinal SystemMedicrea International SA · 2017
- Descendant · 3 generations on · 5 of its ownK233508 iFuse Bedrock Granite® Implant SystemSI-BONE, Inc. · 2024
Show all 11 generations
- Root · 11 generations backK990745 Modification to Synthes Universal Spinal SystemSynthes Spine · 1999
- 10 generations backK992739 Click'xSynthes Spine · 2000 · Recalled
- 9 generations backK040442 Protex Stabilization SystemGlobus Medical, Inc. · 2004
- 8 generations backK052069 Protex Stabilization System with Additional ComponentesGlobus Medical, Inc. · 2005
- 7 generations backK061202 Revere Stabilization SystemGlobus Medical, Inc. · 2006
- 6 generations backK081195 Revere Uniplanar ScrewsGlobus Medical, Inc. · 2008
- 5 generations backK091782 Revere 6.35 Stabilization SystemGlobus Medical, Inc. · 2009
- 4 generations backK093294 Revere Stabilization SystemGlobus Medical, Inc. · 2010
- 3 generations backK100788 Cocr RodsGlobus Medical, Inc. · 2010
- 2 generations backK102488 Apex Spine System W/ Cocr RodsSpinecraft, LLC · 2010
- 1 generation backK110906 Apex Spine SystemSpinecraft, LLC · 2011
- This deviceK132603 Apex Spine SystemSpinecraft, LLC · 2013
Showing 5 of 25 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 25 · See all- K150417Astra Spine SystemSpinecraft, LLC · 2015 · cites it directly21descendants
- K211323ASTRA Spine SystemSpinecraft, LLC · 2021 · 2 generations on12descendants
- K223273ASTRA Spine SystemSpinecraft, LLC · 2022 · 2 generations on8descendants
- K162786PASS LP Spinal SystemMedicrea International SA · 2017 · 2 generations on6descendants
- K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc. · 2024 · 3 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K990745 | Modification to Synthes Universal Spinal System | Synthes Spine | 1999 | — |
| −10 | K992739 | Click'x | Synthes Spine | 2000 | 1 |
| −9 | K040442 | Protex Stabilization System | Globus Medical, Inc. | 2004 | — |
| −8 | K052069 | Protex Stabilization System with Additional Componentes | Globus Medical, Inc. | 2005 | — |
| −7 | K061202 | Revere Stabilization System | Globus Medical, Inc. | 2006 | — |
| −6 | K081195 | Revere Uniplanar Screws | Globus Medical, Inc. | 2008 | — |
| −5 | K091782 | Revere 6.35 Stabilization System | Globus Medical, Inc. | 2009 | — |
| −4 | K093294 | Revere Stabilization System | Globus Medical, Inc. | 2010 | — |
| −3 | K100788 | Cocr Rods | Globus Medical, Inc. | 2010 | — |
| −2 | K102488 | Apex Spine System W/ Cocr Rods | Spinecraft, LLC | 2010 | — |
| −1 | K110906 | Apex Spine System | Spinecraft, LLC | 2011 | — |
| 0 (this device) | K132603 | Apex Spine System | Spinecraft, LLC | 2013 | — |
| +1 | K150417 | Astra Spine System | Spinecraft, LLC | 2015 | — |
| +2 | K211323 | ASTRA Spine System | Spinecraft, LLC | 2021 | — |
| +2 | K223273 | ASTRA Spine System | Spinecraft, LLC | 2022 | — |
| +2 | K162786 | PASS LP Spinal System | Medicrea International SA | 2017 | — |
| +3 | K233508 | iFuse Bedrock Granite® Implant System | SI-BONE, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1990 | 2 | 0 |
| 1992 | 5 | 0 |
| 1993 | 2 | 0 |
| 1994 | 3 | 0 |
| 1995 | 5 | 0 |
| 1996 | 7 | 0 |
| 1997 | 6 | 0 |
| 1998 | 12 | 0 |
| 1999 | 3 | 0 |
| 2000 | 12 | 0 |
| 2001 | 11 | 0 |
| 2002 | 8 | 0 |
| 2003 | 10 | 0 |
| 2004 | 14 | 0 |
| 2005 | 9 | 0 |
| 2006 | 10 | 0 |
| 2007 | 5 | 0 |
| 2008 | 10 | 0 |
| 2009 | 7 | 0 |
| 2010 | 8 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 3 | 0 |
| 2024 | 3 | 0 |
| 2025 | 5 | 0 |
| 2026 | 3 | 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? (12)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K062513 | Apex Spine SystemSummary page 1…per KWO 888.3060 Class III 3. Predicate or legally marketed devices which are substantially equivalent: * APEX Spine System (K062513 / K092825 / K102488 / K1 10906) SpineCraft * Viper Spine System (K090648 / K1 02701) DePuy * Xia Spinal Syste… | 2006 |
| * | K092825 | Apex Spine System 5.50 MM Titanium Rod & Polyaxial Screw WasherSummary page 1…8.3060 Class III 3. Predicate or legally marketed devices which are substantially equivalent: * APEX Spine System (K062513 / K092825 / K102488 / K1 10906) SpineCraft * Viper Spine System (K090648 / K1 02701) DePuy * Xia Spinal System (K1 1366… | 2010 |
| * | K102488 | Apex Spine System W/ Cocr RodsSummary page 1…Class III 3. Predicate or legally marketed devices which are substantially equivalent: * APEX Spine System (K062513 / K092825 / K102488 / K1 10906) SpineCraft * Viper Spine System (K090648 / K1 02701) DePuy * Xia Spinal System (K1 13666 / K071 3… | 2010 |
| * | K110906 | Apex Spine SystemSummary page 1…Class III 3. Predicate or legally marketed devices which are substantially equivalent: * APEX Spine System (K062513 / K092825 / K102488 / K1 10906) SpineCraft * Viper Spine System (K090648 / K1 02701) DePuy * Xia Spinal System (K1 13666 / K071 373 / K06074… | 2011 |
| * | K090648 | Viper 2 SystemSummary page 1…y marketed devices which are substantially equivalent: * APEX Spine System (K062513 / K092825 / K102488 / K1 10906) SpineCraft * Viper Spine System (K090648 / K1 02701) DePuy * Xia Spinal System (K1 13666 / K071 373 / K060748) Stryker * Tiger Spine System (K1 20969)… | 2009 |
| * | K102701 | Viper Spine SystemSummary page 1…devices which are substantially equivalent: * APEX Spine System (K062513 / K092825 / K102488 / K1 10906) SpineCraft * Viper Spine System (K090648 / K1 02701) DePuy * Xia Spinal System (K1 13666 / K071 373 / K060748) Stryker * Tiger Spine System (K1 20969) CoreLink S… | 2010 |
| * | K113666 | Xia 3 Spinal SystemSummary page 1…* APEX Spine System (K062513 / K092825 / K102488 / K1 10906) SpineCraft * Viper Spine System (K090648 / K1 02701) DePuy * Xia Spinal System (K1 13666 / K071 373 / K060748) Stryker * Tiger Spine System (K1 20969) CoreLink Surgical * Firebird Spinal Fixation Sy… | 2012 |
| * | K071373 | Stryker Spine Xia Iii Spinal SystemSummary page 1…APEX Spine System (K062513 / K092825 / K102488 / K1 10906) SpineCraft * Viper Spine System (K090648 / K1 02701) DePuy * Xia Spinal System (K1 13666 / K071 373 / K060748) Stryker * Tiger Spine System (K1 20969) CoreLink Surgical * Firebird Spinal Fixation System, (K1 2… | 2007 |
| * | K060748 | Modification to Xia 4.5 Spinal SystemSummary page 1…System (K062513 / K092825 / K102488 / K1 10906) SpineCraft * Viper Spine System (K090648 / K1 02701) DePuy * Xia Spinal System (K1 13666 / K071 373 / K060748) Stryker * Tiger Spine System (K1 20969) CoreLink Surgical * Firebird Spinal Fixation System, (K1 22901) Orth… | 2006 |
| Kept off the family tree | K120969 | FDA’s K120969 is AC Lens Branded Contact Lens Case Our reading of the summary gave K120969, FDA’s number for AC Lens Branded Contact Lens Case (Arlington Contact Lens Services,Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Tiger Spine System”. Kept off the family tree. Summary page 1…pineCraft * Viper Spine System (K090648 / K1 02701) DePuy * Xia Spinal System (K1 13666 / K071 373 / K060748) Stryker * Tiger Spine System (K1 20969) CoreLink Surgical * Firebird Spinal Fixation System, (K1 22901) Orthofix, Inc. * REVERE® Stabilization Syste… | 2012 |
| * | K122901 | Firebird Spinal Fixation System, Phoenix Mis Spinal Fixation SystemSummary page 1…* Xia Spinal System (K1 13666 / K071 373 / K060748) Stryker * Tiger Spine System (K1 20969) CoreLink Surgical * Firebird Spinal Fixation System, (K1 22901) Orthofix, Inc. * REVERE® Stabilization System, (K093294) Globus Medical Inc 4. Description of the device: Th… | 2012 |
| * | K093294 | Revere Stabilization SystemSummary page 1…* Tiger Spine System (K1 20969) CoreLink Surgical * Firebird Spinal Fixation System, (K1 22901) Orthofix, Inc. * REVERE® Stabilization System, (K093294) Globus Medical Inc 4. Description of the device: The purpose of this submission is to add x-large and uniplanar pedicl… | 2010 |
What descends from it? (25)
See all 252 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 14 years and passes through 3 companies; a new generation was cleared every 11 months on median.
- 13 of the 165 ancestors have a recall of any class.
- Of its descendants, K150417 (Spinecraft, LLC, 2015) has gone furthest, with 21 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. 2013, 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-S1 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-S1 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-SI 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 sacrafiliac 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, lordlosis and/or kyphosis), tumor, and previous failed fusion (pseudo-arthrosis).
When used in a percutaneous, posterior approach with AIM 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 patents . Levels of fixation are for the thoracic, lumbar and sacral spine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132603 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132603: Apex Spine System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132603
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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