510(k) · Cleared
ClearedApex Spine System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spinecraft, Inc. · KWP Appliance, Fixation, Spinal Interlaminal
Cleared on Dec 22, 2006 as substantially equivalent to K010576 (Depuyacromed, 2001) and 4 other predicates after a 116-day review. Its family tree reaches back 4 generations to 1995. 179 later devices descend from it.
- Decided
- Dec 22, 2006
- Review
- 116 days
- Class
- Class II
- Product code
- KWP
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 4 generations to K944736 (1995). 16 ancestors in all. 179 later devices descend from it, 8 citing it directly.
- Root · 4 generations backK944736 VSP (Variable Screw Placement)Acromed Corp. · 1995
- 3 generations backK981274 Acromed Timx Plate Based Low Back SystemAcromed Corp. · 1998
- 2 generations backK010576 Monarch Spine SystemDepuyacromed · 2001
- 1 generation backK024348 Monarch Spine SystemDepuyacromed · 2003
- This deviceK062513 Apex Spine SystemSpinecraft, Inc. · 2006
- Descendant · cites it directly · 178 of its ownK092825 Apex Spine System 5.50 MM Titanium Rod & Polyaxial Screw WasherSpinecraft, Inc. · 2010
- Descendant · cites it directly · 177 of its ownK102488 Apex Spine System W/ Cocr RodsSpinecraft, LLC · 2010
- Descendant · cites it directly · 111 of its ownK120270 Venus Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2012
- Descendant · cites it directly · 103 of its ownK110906 Apex Spine SystemSpinecraft, LLC · 2011
- Descendant · 2 generations on · 81 of its ownK113058 Tiger Spine SystemCorelink, LLC · 2012
Showing 5 of 179 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 179 · See all- K092825Apex Spine System 5.50 MM Titanium Rod & Polyaxial Screw WasherSpinecraft, Inc. · 2010 · cites it directly178descendants
- K102488Apex Spine System W/ Cocr RodsSpinecraft, LLC · 2010 · cites it directly177descendants
- K120270Venus Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2012 · cites it directly111descendants
- K110906Apex Spine SystemSpinecraft, LLC · 2011 · cites it directly103descendants
- K113058Tiger Spine SystemCorelink, LLC · 2012 · 2 generations on81descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K944736 | VSP (Variable Screw Placement) | Acromed Corp. | 1995 | — |
| −3 | K981274 | Acromed Timx Plate Based Low Back System | Acromed Corp. | 1998 | — |
| −2 | K010576 | Monarch Spine System | Depuyacromed | 2001 | — |
| −1 | K024348 | Monarch Spine System | Depuyacromed | 2003 | — |
| 0 (this device) | K062513 | Apex Spine System | Spinecraft, Inc. | 2006 | — |
| +1 | K092825 | Apex Spine System 5.50 MM Titanium Rod & Polyaxial Screw Washer | Spinecraft, Inc. | 2010 | — |
| +1 | K102488 | Apex Spine System W/ Cocr Rods | Spinecraft, LLC | 2010 | — |
| +1 | K120270 | Venus Spinal Fixation System | L&K BIOMED Co., Ltd. | 2012 | — |
| +1 | K110906 | Apex Spine System | Spinecraft, LLC | 2011 | — |
| +2 | K113058 | Tiger Spine System | Corelink, LLC | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 4 | 0 |
| 2013 | 6 | 0 |
| 2014 | 6 | 0 |
| 2015 | 10 | 0 |
| 2016 | 4 | 0 |
| 2017 | 10 | 0 |
| 2018 | 13 | 0 |
| 2019 | 9 | 0 |
| 2020 | 16 | 0 |
| 2021 | 9 | 0 |
| 2022 | 13 | 0 |
| 2023 | 20 | 0 |
| 2024 | 22 | 0 |
| 2025 | 19 | 0 |
| 2026 | 15 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K010576 | Monarch Spine SystemSummary page 2…The APEX Spine System is substantially equivalent to the following predicate devices: * MONARCH Spine System: K010576, K024348 - DePuy AcroMed. * MOSS MIAMI… | 2001 |
| * | K024348 | Monarch Spine SystemSummary page 2…Spine System is substantially equivalent to the following predicate devices: * MONARCH Spine System: K010576, K024348 - DePuy AcroMed. * MOSS MIAMI Spinal S… | 2003 |
| * | K965145 | Depuy Motech Moss Miami Spinal SystemSummary page 2…CH Spine System: K010576, K024348 - DePuy AcroMed. * MOSS MIAMI Spinal System: K965145 - DePuy, Inc. * OPTIMA Spinal System: K051971 - U&I Corp. * G… | 1997 |
| * | K051971 | Optima Spinal SystemSummary page 2…DePuy AcroMed. * MOSS MIAMI Spinal System: K965145 - DePuy, Inc. * OPTIMA Spinal System: K051971 - U&I Corp. * Global Spinal Fixation System: K001668 - D.K.M. Co.,… | 2005 |
| * | K001668 | Global Spinal Fixation SystemSummary page 2…m: K965145 - DePuy, Inc. * OPTIMA Spinal System: K051971 - U&I Corp. * Global Spinal Fixation System: K001668 - D.K.M. Co., Ltd. The substantial equivalence of the APEX spine sy… | 2000 |
What descends from it? (179)
See all 1798 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K092825 | Apex Spine System 5.50 MM Titanium Rod & Polyaxial Screw Washer | 2010 | 178 |
| K102488 | Apex Spine System W/ Cocr Rods | 2010 | 177 |
| K120270 | Venus Spinal Fixation System | 2012 | 111 |
| K110906 | Apex Spine System | 2011 | 103 |
| K132603 | Apex Spine System | 2013 | 25 |
| K150417 | Astra Spine System | 2015 | 21 |
| K143683 | APEX-DL Spine System | 2015 | 3 |
| K121568 | Dali Spinal Fixation System | 2012 | 1 |
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 11 years and passes through 3 companies; a new generation was cleared every 3.1 years on median.
- None of the 16 ancestors has a recall.
- Of its descendants, K092825 (Spinecraft, Inc., 2010) has gone furthest, with 178 descendants of its own.
- 10 other devices also cite its predicate K010576.
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 APEX Spine System 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 (227 words)
The APEX Spine System 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-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
The APEX Spine System is also a hook and 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).
The APEX Spine System when used with pedicle screws are indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies). Levels of fixation are for the thoracic, lumbar and sacral spine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062513 · printed Nov 5, 2026
Cite this page
510(k) Report. “K062513: Apex Spine System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K062513
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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