510(k) · Cleared
ClearedCapLOX II/TowerLOX Pedicle Screw System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Captiva Spine · MNH Orthosis, Spondylolisthesis Spinal Fixation
Cleared on Jun 26, 2015 as substantially equivalent to K131538 (Captiva Spine, 2013) after a 60-day review. Its family tree reaches back 15 generations to 1985. 3 later devices descend from it.
- Decided
- Jun 26, 2015
- Review
- 60 days
- Class
- Class II
- Product code
- MNH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 15 generations to K853033 (1985). 208 ancestors in all, the oldest K841189 (1984). 3 later devices descend from it, 2 citing it directly.
- Root · 15 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 11 generations between
- 3 generations backK111571 Viper SystemsJohnson & Johnson · 2011
- 2 generations backK121020 Viper SystemDepuy Spine, Inc. · 2012
- 1 generation backK131538 Caplox II Pedicle Screw System/Towerlox Pedicle Screw SystemCaptiva Spine · 2013
- This deviceK151116 CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine · 2015
- Descendant · cites it directly · 1 of its ownK172105 The Plateau-LO Spacer SystemLife Spine, Inc. · 2018
- Descendant · 2 generations on · 0 of its ownK182470 Plateau Spacer SystemLife Spine · 2018
- Descendant · cites it directly · 0 of its ownK160020 Captiva Spine and CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine · 2016
Show all 15 generations
- Root · 15 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 14 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
- 13 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
- 12 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
- 11 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
- 10 generations backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
- 9 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
- 8 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
- 7 generations backK062174 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 6 generations backK063156 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 5 generations backK063741 Expedium Spine SystemDepuy Spine, Inc. · 2007
- 4 generations backK080313 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2008
- 3 generations backK111571 Viper SystemsJohnson & Johnson · 2011
- 2 generations backK121020 Viper SystemDepuy Spine, Inc. · 2012
- 1 generation backK131538 Caplox II Pedicle Screw System/Towerlox Pedicle Screw SystemCaptiva Spine · 2013
- This deviceK151116 CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine · 2015
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K853033 | Hartshill Rect & Wires, Spinal Fixation System | A.W. Showell (Surgicraft), Ltd. | 1985 | — |
| −14 | K965221 | Ransford Cervical Fixation System | Surgicraft, Ltd. | 1997 | — |
| −13 | K982322 | Synthes Spine Occipital-Cervical Plate/Rod and Hook System | Synthes (Usa) | 1998 | — |
| −12 | K002733 | Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2000 | — |
| −11 | K013222 | Summit Occipito-Cervico- Thoracic (Oct) Spinal System | Depuyacromed | 2001 | — |
| −10 | K022190 | Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2002 | — |
| −9 | K030103 | Summit Oct Spinal System Minipolyaxial Screws | Depuyacromed | 2003 | — |
| −8 | K041203 | Summit Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
| −7 | K062174 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| −6 | K063156 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| −5 | K063741 | Expedium Spine System | Depuy Spine, Inc. | 2007 | — |
| −4 | K080313 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2008 | — |
| −3 | K111571 | Viper Systems | Johnson & Johnson | 2011 | — |
| −2 | K121020 | Viper System | Depuy Spine, Inc. | 2012 | — |
| −1 | K131538 | Caplox II Pedicle Screw System/Towerlox Pedicle Screw System | Captiva Spine | 2013 | — |
| 0 (this device) | K151116 | CapLOX II/TowerLOX Pedicle Screw System | Captiva Spine | 2015 | — |
| +1 | K172105 | The Plateau-LO Spacer System | Life Spine, Inc. | 2018 | — |
| +2 | K182470 | Plateau Spacer System | Life Spine | 2018 | — |
| +1 | K160020 | Captiva Spine and CapLOX II/TowerLOX Pedicle Screw System | Captiva Spine | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1990 | 2 | 0 |
| 1992 | 5 | 0 |
| 1993 | 3 | 0 |
| 1994 | 1 | 0 |
| 1995 | 5 | 0 |
| 1996 | 5 | 0 |
| 1997 | 3 | 0 |
| 1998 | 10 | 0 |
| 1999 | 9 | 0 |
| 2000 | 13 | 0 |
| 2001 | 14 | 0 |
| 2002 | 9 | 0 |
| 2003 | 11 | 0 |
| 2004 | 25 | 0 |
| 2005 | 23 | 0 |
| 2006 | 12 | 0 |
| 2007 | 8 | 0 |
| 2008 | 9 | 0 |
| 2009 | 10 | 0 |
| 2010 | 7 | 0 |
| 2011 | 5 | 0 |
| 2012 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2018 | 2 | 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? (1)
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 |
|---|---|---|---|
| * | K131538 | Caplox II Pedicle Screw System/Towerlox Pedicle Screw SystemSummary page 6…sing tower pedicle screw head assembly Table 5-1 Predicate Devices 510k Number Trade or Proprietary or Model Name Manufacturer Type K131538 CapLOX II/TowerLOX Pedicle Screw System Captiva Spine Primary CONCLUSION The subject modified is CapLO… | 2013 |
What descends from it? (3)
2 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 30 years and passes through 7 companies; a new generation was cleared every 1.3 years on median.
- 19 of the 208 ancestors have a recall of any class.
- Of its descendants, K172105 (Life Spine, Inc., 2018) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K131538.
How does its category compare?
All MNH devicesMNH Orthosis, Spondylolisthesis Spinal Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 CapLOX II/TowerLOX Pedicle Screw System is a posterior, non-cervical pedicle fixation 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 including degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation…
Read the full statement (148 words)
The CapLOX II/TowerLOX Pedicle Screw System is a posterior, non-cervical pedicle fixation 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 including degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, pseudloarthrosis and failed previous fusion.
In addition, when used as a pedicle screw fixation system, the CapLOX II/TowerLOX Pedicle Screw System is intended for skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral, L5-S1 vertebra, who are receiving fusion by autogenous bone graft only, who are having the device attached to the lumbar and sacral spine (levels may be from L3 to the sacrum/ilium), who are having the device removed after the attainment of a solid fusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151116 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151116: CapLOX II/TowerLOX Pedicle Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151116
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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