510(k) · Cleared
ClearedCaptiva Spine Caplox II Spinal Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Captiva Spine, Inc. · MNI Orthosis, Spinal Pedicle Fixation
Cleared on Sep 13, 2011 as substantially equivalent to K100956 (Allure Spine LLC, 2010) and 3 other predicates after a 145-day review. Its family tree reaches back 8 generations to 1995. 16 later devices descend from it.
- Decided
- Sep 13, 2011
- Review
- 145 days
- Class
- Class II
- Product code
- MNI
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 8 generations to K951116 (1995). 50 ancestors in all, the oldest K901587 (1990). 16 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK951116 Acromed Pedicle ScrewAcromed Corp. · 1995
- 7 generations backK963639 Acromed Pedicle ScrewAcromed Corp. · 1996
- 6 generations backK982511 Depuy Motech Moss Miami Spinal SystemsDepuy, Inc. · 1998
- 5 generations backK030383 Modification to Moss Miami Spinal System Polyaxial ScrewsDepuyacromed · 2003
- 4 generations backK070245 Capsure Pedicle Screw SystemSpine Wave, Inc. · 2007
- 3 generations backK081228 Capsure PS (R) Spine SystemSpine Wave, Inc. · 2008
- 2 generations backK083353 Capsure (R) PS SystemSpine Wave, Inc. · 2008
- 1 generation backK100605 Mis SystemSpine Wave, Inc. · 2010
- This deviceK111115 Captiva Spine Caplox II Spinal Fixation SystemCaptiva Spine, Inc. · 2011
- Descendant · cites it directly · 15 of its ownK120292 Caplox II Pedicle Screw SystemCaptiva Spine, Inc. · 2012 · Recalled
- Descendant · cites it directly · 14 of its ownK122332 Towerlox Pedicle Screw SystemCaptiva Spine · 2012
- Descendant · 2 generations on · 6 of its ownK131538 Caplox II Pedicle Screw System/Towerlox Pedicle Screw SystemCaptiva Spine · 2013
- Descendant · 2 generations on · 5 of its ownK152781 Adena-Zina SystemShanghai Sanyou Medical Co, Ltd. · 2016
- Descendant · 3 generations on · 3 of its ownK212066 Adena-Zina SystemShanghai Sanyou Medical Co, Ltd. · 2021
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K120292Caplox II Pedicle Screw SystemCaptiva Spine, Inc. · 2012 · cites it directly15descendants
- K122332Towerlox Pedicle Screw SystemCaptiva Spine · 2012 · cites it directly14descendants
- K131538Caplox II Pedicle Screw System/Towerlox Pedicle Screw SystemCaptiva Spine · 2013 · 2 generations on6descendants
- K152781Adena-Zina SystemShanghai Sanyou Medical Co, Ltd. · 2016 · 2 generations on5descendants
- K212066Adena-Zina SystemShanghai Sanyou Medical Co, Ltd. · 2021 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K951116 | Acromed Pedicle Screw | Acromed Corp. | 1995 | — |
| −7 | K963639 | Acromed Pedicle Screw | Acromed Corp. | 1996 | — |
| −6 | K982511 | Depuy Motech Moss Miami Spinal Systems | Depuy, Inc. | 1998 | — |
| −5 | K030383 | Modification to Moss Miami Spinal System Polyaxial Screws | Depuyacromed | 2003 | — |
| −4 | K070245 | Capsure Pedicle Screw System | Spine Wave, Inc. | 2007 | — |
| −3 | K081228 | Capsure PS (R) Spine System | Spine Wave, Inc. | 2008 | — |
| −2 | K083353 | Capsure (R) PS System | Spine Wave, Inc. | 2008 | — |
| −1 | K100605 | Mis System | Spine Wave, Inc. | 2010 | — |
| 0 (this device) | K111115 | Captiva Spine Caplox II Spinal Fixation System | Captiva Spine, Inc. | 2011 | — |
| +1 | K120292 | Caplox II Pedicle Screw System | Captiva Spine, Inc. | 2012 | 1 |
| +1 | K122332 | Towerlox Pedicle Screw System | Captiva Spine | 2012 | — |
| +2 | K131538 | Caplox II Pedicle Screw System/Towerlox Pedicle Screw System | Captiva Spine | 2013 | — |
| +2 | K152781 | Adena-Zina System | Shanghai Sanyou Medical Co, Ltd. | 2016 | — |
| +3 | K212066 | Adena-Zina System | Shanghai Sanyou Medical Co, Ltd. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 2 | 0 |
| 1992 | 5 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 4 | 0 |
| 1999 | 2 | 0 |
| 2000 | 3 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 3 | 0 |
| 2004 | 4 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 3 | 0 |
| 2018 | 3 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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 MNI? 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K100956 | Spondy Spinal Fixation SystemSummary page 1…070 Product Code: MNI, MNH Predicate Device(s): The subject device is substantially equivalent to the following devices: K100956 Spondy Spinal Fixation System K024096 Optima, Spinal System K950099 Synergy… | 2010 |
| * | K024096 | Optima, Spinal SystemSummary page 1…The subject device is substantially equivalent to the following devices: K100956 Spondy Spinal Fixation System K024096 Optima, Spinal System K950099 Synergy VILS System K100605 Spine Wave MIS Sy… | 2003 |
| * | K950099 | Synergy (TM) TI Posterior Spinal SystemSummary page 1…e following devices: K100956 Spondy Spinal Fixation System K024096 Optima, Spinal System K950099 Synergy VILS System K100605 Spine Wave MIS System Device Description: The Captiva Spine CapLOX… | 1997 |
| * | K100605 | Mis SystemSummary page 1…Spondy Spinal Fixation System K024096 Optima, Spinal System K950099 Synergy VILS System K100605 Spine Wave MIS System Device Description: The Captiva Spine CapLOX 11 Spinal System is a top-loading spinal… | 2010 |
What descends from it? (16)
See all 162 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 16 years and passes through 5 companies; a new generation was cleared every 1.5 years on median.
- 5 of the 50 ancestors have a recall of any class.
- Of its descendants, K120292 (Captiva Spine, Inc., 2012) has gone furthest, with 15 descendants of its own.
How does its category compare?
All MNI devicesMNI Orthosis, Spinal Pedicle Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · MNI
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · MNI
168in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MNI
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MNI
80in 2025
MAUDE reports naming product code MNI, 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 | 20 | 82 | 26 | 83 |
| 2008 | 23 | 64 | 8 | 108 |
| 2009 | 18 | 86 | 3 | 138 |
| 2010 | 16 | 74 | 1 | 126 |
| 2011 | 17 | 111 | 0 | 146 |
| 2012 | 19 | 75 | 1 | 200 |
| 2013 | 14 | 77 | 4 | 824 |
| 2014 | 6 | 104 | 0 | 301 |
| 2015 | 12 | 54 | 1 | 260 |
| 2016 | 7 | 168 | 0 | 117 |
| 2017 | 1 | — | 0 | 247 |
| 2018 | 0 | — | 1 | 134 |
| 2019 | 0 | — | 0 | 188 |
| 2020 | 0 | — | 0 | 115 |
| 2021 | 0 | — | 0 | 270 |
| 2022 | 0 | — | 0 | 214 |
| 2023 | 0 | — | 0 | 122 |
| 2024 | 0 | — | 0 | 114 |
| 2025 | 0 | — | 0 | 80 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The CapLOX 11Spinal 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 sacrat spine including degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis…
Read the full statement (144 words)
The CapLOX 11Spinal 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 sacrat 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 11Spinal System is intended for skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral, [S-Si 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 [3 to the sacrum/ilium), who are having the device removed after the attainment of a solid fusion.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K111115 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111115: Captiva Spine Caplox II Spinal Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111115
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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