510(k) · Cleared
ClearedApex Spine System 5.50 MM Titanium Rod & Polyaxial Screw Washer
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 Mar 16, 2010 as substantially equivalent to K062513 (Spinecraft, Inc., 2006) and 2 other predicates after a 186-day review. Its family tree reaches back 5 generations to 1995. 178 later devices descend from it.
- Decided
- Mar 16, 2010
- Review
- 186 days
- Class
- Class II
- Product code
- KWP
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 5 generations to K944736 (1995). 20 ancestors in all. 178 later devices descend from it, 7 citing it directly.
- Root · 5 generations backK944736 VSP (Variable Screw Placement)Acromed Corp. · 1995
- 4 generations backK981274 Acromed Timx Plate Based Low Back SystemAcromed Corp. · 1998
- 3 generations backK010576 Monarch Spine SystemDepuyacromed · 2001
- 2 generations backK024348 Monarch Spine SystemDepuyacromed · 2003
- 1 generation backK062513 Apex Spine SystemSpinecraft, Inc. · 2006
- This deviceK092825 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
- Descendant · 2 generations on · 75 of its ownK123549 Polaris Spinal System - Ballista II Percutaneous Screw Placement…Biomet Spine (Aka Ebi, LLC) · 2013 · Recalled
Showing 5 of 178 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 178 · See all- 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
- K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC) · 2013 · 2 generations on75descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K944736 | VSP (Variable Screw Placement) | Acromed Corp. | 1995 | — |
| −4 | K981274 | Acromed Timx Plate Based Low Back System | Acromed Corp. | 1998 | — |
| −3 | K010576 | Monarch Spine System | Depuyacromed | 2001 | — |
| −2 | K024348 | Monarch Spine System | Depuyacromed | 2003 | — |
| −1 | K062513 | Apex Spine System | Spinecraft, Inc. | 2006 | — |
| 0 (this device) | 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 | — |
| +2 | K123549 | Polaris Spinal System - Ballista II Percutaneous Screw Placement System | Biomet Spine (Aka Ebi, LLC) | 2013 | 2 |
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 | 4 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 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? (4)
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 2…ine System is substantially equivalent to the following predicate devices: *APEX Spine System: K062513 - SpineCraft *MONARCH Spine System: K0l10576, K024348 - DePuy… | 2006 |
| Kept off the family tree | K011057 | FDA’s K011057 is Intercept Oral Fluid Drug Test Oral Specimen Collection Device, Model 503-XXXX Our reading of the summary gave K011057, FDA’s number for Intercept Oral Fluid Drug Test Oral Specimen Collection… (OraSure Technologies, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “MONARCH Spine System”. Kept off the family tree. | 2001 |
| * | K024348 | Monarch Spine SystemSummary page 2…cate devices: *APEX Spine System: K062513 - SpineCraft *MONARCH Spine System: K0l10576, K024348 - DePuy AcroMed, Inc. *MOSS MIAMI Spin… | 2003 |
| * | K013296 | Moss Miami Spinal SystemsSummary page 2…ystem: K0l10576, K024348 - DePuy AcroMed, Inc. *MOSS MIAMI Spinal System: K013296 - DePuy AcroMed, Inc. The substantial equivale… | 2001 |
What descends from it? (178)
See all 1787 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 15 years and passes through 3 companies; a new generation was cleared every 3.1 years on median.
- None of the 20 ancestors has a recall.
- Of its descendants, K102488 (Spinecraft, LLC, 2010) has gone furthest, with 177 descendants of its own.
- 7 other devices also cite its predicate K062513.
How does its category compare?
All KWP devicesKWP Appliance, Fixation, Spinal Interlaminal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
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 5.5mm Rod and Polyaxial Screw Washers 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 LS-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment…
Read the full statement (250 words)
The APEX Spine System 5.5mm Rod and Polyaxial Screw Washers 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 LS-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 5.5mm Rod and Polyaxial Screw Washers 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 (L_3 to sacrum) with removal of the implants after the attainment of a~solid fusion,
The APEX Spine System 5.5mm Rod and Polyaxial Screw Washers 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 studfies); 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 5.5mm Rod and Polyaxial Screw Washers 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/K092825 · printed Nov 4, 2026
Cite this page
510(k) Report. “K092825: Apex Spine System 5.50 MM Titanium Rod & Polyaxial Screw Washer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092825
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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