510(k) · Cleared
ClearedApex Spine System W/ Cocr Rods
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spinecraft, LLC · MNH Orthosis, Spondylolisthesis Spinal Fixation
Cleared on Dec 10, 2010 as substantially equivalent to K062513 (Spinecraft, Inc., 2006) and 5 other predicates after a 101-day review. Its family tree reaches back 9 generations to 1999. 177 later devices descend from it.
- Decided
- Dec 10, 2010
- Review
- 101 days
- Class
- Class II
- Product code
- MNH
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 9 generations to K990745 (1999). 60 ancestors in all, the oldest K944736 (1995). 177 later devices descend from it, 7 citing it directly.
- Root · 9 generations backK990745 Modification to Synthes Universal Spinal SystemSynthes Spine · 1999
- 5 generations between
- 3 generations backK091782 Revere 6.35 Stabilization SystemGlobus Medical, Inc. · 2009
- 2 generations backK093294 Revere Stabilization SystemGlobus Medical, Inc. · 2010
- 1 generation backK100788 Cocr RodsGlobus Medical, Inc. · 2010
- This deviceK102488 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
- Descendant · 3 generations on · 70 of its ownK131615 Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC) · 2013
Show all 9 generations
- Root · 9 generations backK990745 Modification to Synthes Universal Spinal SystemSynthes Spine · 1999
- 8 generations backK992739 Click'xSynthes Spine · 2000 · Recalled
- 7 generations backK040442 Protex Stabilization SystemGlobus Medical, Inc. · 2004
- 6 generations backK052069 Protex Stabilization System with Additional ComponentesGlobus Medical, Inc. · 2005
- 5 generations backK061202 Revere Stabilization SystemGlobus Medical, Inc. · 2006
- 4 generations backK081195 Revere Uniplanar ScrewsGlobus Medical, Inc. · 2008
- 3 generations backK091782 Revere 6.35 Stabilization SystemGlobus Medical, Inc. · 2009
- 2 generations backK093294 Revere Stabilization SystemGlobus Medical, Inc. · 2010
- 1 generation backK100788 Cocr RodsGlobus Medical, Inc. · 2010
- This deviceK102488 Apex Spine System W/ Cocr RodsSpinecraft, LLC · 2010
Showing 5 of 177 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 177 · See all- 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
- K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC) · 2013 · 3 generations on70descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K990745 | Modification to Synthes Universal Spinal System | Synthes Spine | 1999 | — |
| −8 | K992739 | Click'x | Synthes Spine | 2000 | 1 |
| −7 | K040442 | Protex Stabilization System | Globus Medical, Inc. | 2004 | — |
| −6 | K052069 | Protex Stabilization System with Additional Componentes | Globus Medical, Inc. | 2005 | — |
| −5 | K061202 | Revere Stabilization System | Globus Medical, Inc. | 2006 | — |
| −4 | K081195 | Revere Uniplanar Screws | Globus Medical, Inc. | 2008 | — |
| −3 | K091782 | Revere 6.35 Stabilization System | Globus Medical, Inc. | 2009 | — |
| −2 | K093294 | Revere Stabilization System | Globus Medical, Inc. | 2010 | — |
| −1 | K100788 | Cocr Rods | Globus Medical, Inc. | 2010 | — |
| 0 (this device) | 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 |
| +3 | K131615 | Polaris Spinal System | Biomet Spine (Aka Ebi, LLC) | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 5 | 0 |
| 1999 | 2 | 0 |
| 2000 | 7 | 0 |
| 2001 | 5 | 0 |
| 2002 | 2 | 0 |
| 2003 | 6 | 0 |
| 2004 | 7 | 0 |
| 2005 | 5 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 MNH? 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? (6)
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…888.3050 Class 11 3. Predicate or legally marketed devices which are substantially equivalent: * APEX Spine System w/ Ti Rods (K062513 IK092825) /SpineCraft * Beacon / Revere Ti & CoCr Rods (K(092610/1K100788)/ Globus * Range / Denali Ti & CoCr R… | 2006 |
| * | K092825 | Apex Spine System 5.50 MM Titanium Rod & Polyaxial Screw WasherSummary page 1…Class 11 3. Predicate or legally marketed devices which are substantially equivalent: * APEX Spine System w/ Ti Rods (K062513 IK092825) /SpineCraft * Beacon / Revere Ti & CoCr Rods (K(092610/1K100788)/ Globus * Range / Denali Ti & CoCr Rods (K(07… | 2010 |
| * | K092610 | Modification to Beacon Stabilization SystemSummary page 2…Rods Rods Sponsor SpineCraft SpineCraft Globus K2M 510O(k) Current K062513 IK092610 IK070229 I Number submission K092825 K100788 K080792… | 2009 |
| * | K100788 | Cocr RodsSummary page 1…devices which are substantially equivalent: * APEX Spine System w/ Ti Rods (K062513 IK092825) /SpineCraft * Beacon / Revere Ti & CoCr Rods (K(092610/1K100788)/ Globus * Range / Denali Ti & CoCr Rods (K(070229 / K(080792) / K2M 4. Description of the device: The added 05… | 2010 |
| * | K070229 | Range Spinal SystemSummary page 2…Rods Sponsor SpineCraft SpineCraft Globus K2M 510O(k) Current K062513 IK092610 IK070229 I Number submission K092825 K100788 K080792 05.5mm… | 2007 |
| * | K080792 | K2M Cocr RodSummary page 1…ivalent to the APEX w/ Ti Rod (K(062513/ K092825), Beacon / Revere w/ Ti & Co~r Rods (K(092610 / K(100788) and Range / Denali w/ Ti & CoCr Rods (K(070229 / K080792) in terms of intended use, design, materials used, mechanical Page 1 === Pag… | 2008 |
What descends from it? (177)
See all 1777 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| 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 |
| K132644 | Lospa IS Pedicle Screw (Monoaxial & Polyaxial), Lospa IS Rod- Straight (Standard), Lospa… | 2013 | 0 |
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 11 months on median.
- 4 of the 60 ancestors have a recall of any class.
- Of its descendants, K120270 (L&K BIOMED Co., Ltd., 2012) has gone furthest, with 111 descendants of its own.
- 7 other devices also cite its predicate K062513.
How does its category compare?
All MNH devicesMNH Orthosis, Spondylolisthesis Spinal Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · MNH
8in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · MNH
93in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MNH
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MNH
89in 2025
MAUDE reports naming product code MNH, 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 | 5 | 123 | 0 | 18 |
| 2008 | 13 | 65 | 0 | 30 |
| 2009 | 13 | 151 | 7 | 45 |
| 2010 | 10 | 106 | 0 | 59 |
| 2011 | 17 | 171 | 0 | 107 |
| 2012 | 7 | 93 | 1 | 433 |
| 2013 | 10 | 124 | 1 | 464 |
| 2014 | 12 | 140 | 0 | 286 |
| 2015 | 10 | 99 | 0 | 152 |
| 2016 | 8 | 93 | 1 | 216 |
| 2017 | 0 | — | 0 | 174 |
| 2018 | 0 | — | 0 | 129 |
| 2019 | 0 | — | 0 | 403 |
| 2020 | 0 | — | 0 | 432 |
| 2021 | 0 | — | 0 | 531 |
| 2022 | 0 | — | 0 | 265 |
| 2023 | 0 | — | 0 | 121 |
| 2024 | 0 | — | 0 | 302 |
| 2025 | 0 | — | 0 | 89 |
| 2026 | 0 | — | 0 | — |
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 neurological impairment, fracture, dislocation, scoliosis…
Read the full statement (186 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 neurological impairment, fracture, dislocation, scoliosis, kylphosis, spinal tumor, and failed previous fusion (pseudo-arthrosis).
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).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102488 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102488: Apex Spine System W/ Cocr Rods.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102488
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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