510(k) · Cleared
ClearedCaplox II Pedicle Screw System/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 Aug 8, 2013 as substantially equivalent to K122332 (Captiva Spine, 2012) and 2 other predicates after a 71-day review. Its family tree reaches back 14 generations to 1985. 6 later devices descend from it.
- Decided
- Aug 8, 2013
- Review
- 71 days
- Class
- Class II
- Product code
- MNH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 14 generations to K853033 (1985). 207 ancestors in all, the oldest K841189 (1984). 6 later devices descend from it, 3 citing it directly.
- Root · 14 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 10 generations between
- 3 generations backK080313 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2008
- 2 generations backK111571 Viper SystemsJohnson & Johnson · 2011
- 1 generation backK121020 Viper SystemDepuy Spine, Inc. · 2012
- This deviceK131538 Caplox II Pedicle Screw System/Towerlox Pedicle Screw SystemCaptiva Spine · 2013
- Descendant · cites it directly · 3 of its ownK151116 CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine · 2015
- Descendant · 2 generations on · 1 of its ownK172105 The Plateau-LO Spacer SystemLife Spine, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK193270 CapLOX II®/TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc. · 2020
- Descendant · 3 generations on · 0 of its ownK182470 Plateau Spacer SystemLife Spine · 2018
- Descendant · cites it directly · 0 of its ownK180475 CapLOX II® / TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc. · 2018
Show all 14 generations
- Root · 14 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 13 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
- 12 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
- 11 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
- 10 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
- 9 generations backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
- 8 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
- 7 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
- 6 generations backK062174 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 5 generations backK063156 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
- 4 generations backK063741 Expedium Spine SystemDepuy Spine, Inc. · 2007
- 3 generations backK080313 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2008
- 2 generations backK111571 Viper SystemsJohnson & Johnson · 2011
- 1 generation backK121020 Viper SystemDepuy Spine, Inc. · 2012
- This deviceK131538 Caplox II Pedicle Screw System/Towerlox Pedicle Screw SystemCaptiva Spine · 2013
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K151116CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine · 2015 · cites it directly3descendants
- K172105The Plateau-LO Spacer SystemLife Spine, Inc. · 2018 · 2 generations on1descendant
- K193270CapLOX II®/TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc. · 2020 · cites it directly0descendants
- K182470Plateau Spacer SystemLife Spine · 2018 · 3 generations on0descendants
- K180475CapLOX II® / TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc. · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K853033 | Hartshill Rect & Wires, Spinal Fixation System | A.W. Showell (Surgicraft), Ltd. | 1985 | — |
| −13 | K965221 | Ransford Cervical Fixation System | Surgicraft, Ltd. | 1997 | — |
| −12 | K982322 | Synthes Spine Occipital-Cervical Plate/Rod and Hook System | Synthes (Usa) | 1998 | — |
| −11 | K002733 | Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2000 | — |
| −10 | K013222 | Summit Occipito-Cervico- Thoracic (Oct) Spinal System | Depuyacromed | 2001 | — |
| −9 | K022190 | Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2002 | — |
| −8 | K030103 | Summit Oct Spinal System Minipolyaxial Screws | Depuyacromed | 2003 | — |
| −7 | K041203 | Summit Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
| −6 | K062174 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| −5 | K063156 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2006 | — |
| −4 | K063741 | Expedium Spine System | Depuy Spine, Inc. | 2007 | — |
| −3 | K080313 | Modification to Expedium Spine System | Depuy Spine, Inc. | 2008 | — |
| −2 | K111571 | Viper Systems | Johnson & Johnson | 2011 | — |
| −1 | K121020 | Viper System | Depuy Spine, Inc. | 2012 | — |
| 0 (this device) | K131538 | Caplox II Pedicle Screw System/Towerlox Pedicle Screw System | Captiva Spine | 2013 | — |
| +1 | K151116 | CapLOX II/TowerLOX Pedicle Screw System | Captiva Spine | 2015 | — |
| +2 | K172105 | The Plateau-LO Spacer System | Life Spine, Inc. | 2018 | — |
| +1 | K193270 | CapLOX II®/TowerLOX® MIS Pedicle Screw System | Captiva Spine, Inc. | 2020 | — |
| +3 | K182470 | Plateau Spacer System | Life Spine | 2018 | — |
| +1 | K180475 | CapLOX II® / TowerLOX® MIS Pedicle Screw System | Captiva Spine, Inc. | 2018 | — |
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 |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 3 | 0 |
| 2020 | 1 | 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? (3)
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 |
|---|---|---|---|
| * | K122332 | Towerlox Pedicle Screw SystemSummary page 2…dicate Device(s): The CapLOX Il/TowerLOX Pedlicle Screw System is substantially equivalent to the previously cleared CapL-OX Il/TowerL-OX pedicle screw system found in K(122332, the CapLOX 11Pedicle Screw System (K120292) and the Depuy Viper Spinal System (K121020). Performance Standards: Based on the ri… | 2012 |
| * | K120292 | Caplox II Pedicle Screw SystemSummary page 2…dlicle Screw System is substantially equivalent to the previously cleared CapL-OX Il/TowerL-OX pedicle screw system found in K(122332, the CapLOX 11Pedicle Screw System (K120292) and the Depuy Viper Spinal System (K121020). Performance Standards: Based on the risk analysis for the proposed changes, no new… | 2012 |
| * | K121020 | Viper SystemSummary page 2…ent to the previously cleared CapL-OX Il/TowerL-OX pedicle screw system found in K(122332, the CapLOX 11Pedicle Screw System (K120292) and the Depuy Viper Spinal System (K121020). Performance Standards: Based on the risk analysis for the proposed changes, no new performance testing is required. Conclusio… | 2012 |
What descends from it? (6)
3 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 28 years and passes through 7 companies; a new generation was cleared every 1.3 years on median.
- 19 of the 207 ancestors have a recall of any class.
- Of its descendants, K151116 (Captiva Spine, 2015) has gone furthest, with 3 descendants of its own.
- 2 other devices also cite its predicate K122332.
How does its category compare?
All MNH devicesMNH Orthosis, Spondylolisthesis Spinal Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 ]I/TowerLOX Pedicle Screw System isa 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 (146 words)
The CapLOX ]I/TowerLOX Pedicle Screw System isa 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, pseudoarthrosis and failed previous fusion.
In addition, when used as a pedicle screw fixation system, the CapLOX Il/TowerLOX Pedicle Screw System isintended for skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral, LS-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 13 to the sacruni/iliurn), 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/K131538 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131538: Caplox II Pedicle Screw System/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/K131538
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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