510(k) Report

510(k) · Cleared

Cleared

Towerlox Pedicle Screw System

K122332510(k) SpecialCleared Oct 16, 201275-day reviewClass II21 CFR 888.3070

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Captiva Spine · MNI Orthosis, Spinal Pedicle Fixation

Cleared on Oct 16, 2012 as substantially equivalent to K111115 (Captiva Spine, Inc., 2011) and 6 other predicates after a 75-day review. Its family tree reaches back 13 generations to 2004. 14 later devices descend from it.

Decided
Oct 16, 2012
Review
75 days
Class
Class II
Product code
MNI
Recalls
None
Predicates
7

Its longest line of descent runs back 13 generations to K040583 (2004). 141 ancestors in all, the oldest K841189 (1984). 14 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2012: 1 other ancestor2011: 3 other ancestors2009: 6 other ancestors2006: 8 other ancestors2005: 14 other ancestors2010: 4 other ancestors2008: 5 other ancestors2003: 8 other ancestors1997: 2 other ancestors2007: 5 other ancestors2004: 21 other ancestors2002: 7 other ancestors2000: 9 other ancestors1999: 3 other ancestors1993: 2 other ancestors1992: 5 other ancestors1990: 2 other ancestors1996: 5 other ancestors2001: 7 other ancestors1998: 6 other ancestors1984: 1 other ancestor1995: 3 other ancestors1994: 1 other ancestor2013: 1 descendant cleared2016: 3 descendants cleared2015: 1 descendant cleared2020: 1 descendant cleared2018: 3 descendants cleared2023: 2 descendants cleared2021: 1 descendant cleared2024: 1 descendant cleared2025: 1 descendant cleared×7: 7 generations cleared close together, K040583 (2004), K041118 (2004), K042025 (2004), K043151 (2005), K050809 (2005), K052187 (2005), K053101 (2006) ×2: 2 generations cleared close together, K091442 (2009), K091974 (2009) K102555 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2010×2: 2 generations cleared close together, K112473 (2011), K113174 (2011) K121680 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 201219801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 6 other ancestors2 generations back: 12 other ancestors3 generations back: 45 other ancestors4 generations back: 21 other ancestors5 generations back: 16 other ancestors6 generations back: 12 other ancestors7 generations back: 16 other ancestors 1 generation forward: 3 descendants2 generations forward: 7 descendants3 generations forward: 3 descendants4 generations forward: 1 descendant K121680 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2012K113174 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2011 · recalledK112473 · CD Horizon Spinal System · Medtronic Sofamor Danek, Inc. · 2011K102555 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2010K091974 · Modification to CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2009 · recalledK091442 · CD Horizon Spinal System · Medtronic Sofamor Danek · 2009K053101 · CD Horizon Spinal System · Medtronic Sofamor Danek · 2006K052187 · Modification to: CD Horizon Spinal System · Medtronic Sofamor Danek · 2005K050809 · CD Horizon Spinal System · Medtronic Sofamor Danek USA, Inc. · 2005K043151 · Modification to: CD Horizon Spinal System · Medtronic Sofamor Danek · 2005K042025 · Modification to CD Horizon Spinal System · Medtronic Sofamor Danek, Inc. · 2004 · recalledK041118 · Modification to CD Horizon Spinal System · Medtronic Sofamor Danek · 2004K040583 · Modification to: CD Horizon Spinal System · Medtronic Sofamor Danek · 2004−10−50
  1. Root · 13 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  2. 9 generations between
  3. 3 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
  4. 2 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
  5. 1 generation backK121680 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
  6. This deviceK122332 Towerlox Pedicle Screw SystemCaptiva Spine · 2012
  7. Descendant · cites it directly · 6 of its ownK131538 Caplox II Pedicle Screw System/Towerlox Pedicle Screw SystemCaptiva Spine · 2013
  8. Descendant · cites it directly · 5 of its ownK152781 Adena-Zina SystemShanghai Sanyou Medical Co, Ltd. · 2016
  9. Descendant · 2 generations on · 3 of its ownK212066 Adena-Zina SystemShanghai Sanyou Medical Co, Ltd. · 2021
  10. Descendant · 2 generations on · 3 of its ownK151116 CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine · 2015
  11. Descendant · 2 generations on · 2 of its ownK230961 Zeus Spinal SystemShanghai Sanyou Medical Co, Ltd. · 2023
Show all 13 generations
  1. Root · 13 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  2. 12 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  3. 11 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
  4. 10 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
  5. 9 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
  6. 8 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
  7. 7 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
  8. 6 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
  9. 5 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
  10. 4 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
  11. 3 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
  12. 2 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
  13. 1 generation backK121680 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
  14. This deviceK122332 Towerlox Pedicle Screw SystemCaptiva Spine · 2012

Showing 5 of 14 descendants. See all descendants

Descendants cleared per year

2013: 12015: 12016: 32018: 32020: 12021: 12023: 22024: 12025: 1
2013high 3 (2016) · low 0 (2014)2026

Most influential descendants

Showing 5 of 14 · See all
  • K131538Caplox II Pedicle Screw System/Towerlox Pedicle Screw SystemCaptiva Spine · 2013 · cites it directly6descendants
  • K152781Adena-Zina SystemShanghai Sanyou Medical Co, Ltd. · 2016 · cites it directly5descendants
  • K212066Adena-Zina SystemShanghai Sanyou Medical Co, Ltd. · 2021 · 2 generations on3descendants
  • K151116CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine · 2015 · 2 generations on3descendants
  • K230961Zeus Spinal SystemShanghai Sanyou Medical Co, Ltd. · 2023 · 2 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−13K040583Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2004—
−12K041118Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek2004—
−11K042025Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.20044
−10K043151Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005—
−9K050809CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2005—
−8K052187Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005—
−7K053101CD Horizon Spinal SystemMedtronic Sofamor Danek2006—
−6K091442CD Horizon Spinal SystemMedtronic Sofamor Danek2009—
−5K091974Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20091
−4K102555CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2010—
−3K112473CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2011—
−2K113174CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20111
−1K121680CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2012—
0 (this device)K122332Towerlox Pedicle Screw SystemCaptiva Spine2012—
+1K131538Caplox II Pedicle Screw System/Towerlox Pedicle Screw SystemCaptiva Spine2013—
+1K152781Adena-Zina SystemShanghai Sanyou Medical Co, Ltd.2016—
+2K212066Adena-Zina SystemShanghai Sanyou Medical Co, Ltd.2021—
+2K151116CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine2015—
+2K230961Zeus Spinal SystemShanghai Sanyou Medical Co, Ltd.2023—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198410
199020
199250
199320
199410
199530
199650
199720
199860
199930
200090
200170
200270
200380
2004210
2005140
200680
200750
200850
200960
201040
201130
201210

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201310
201510
201630
201830
202010
202110
202320
202410
202510
FIG. 1 — Lineage of K122332, 2004–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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
Get a 510(k) Report

What was it cleared against? (7)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K111115Captiva Spine Caplox II Spinal Fixation SystemCaptiva Spine, Inc.2011—
*K120292Caplox II Pedicle Screw System
Summary page 1
…MNI, MNhH Panel Code: 87 Predicate Device(s): CapLOX II Pedicle Screw System (Ki 11115, SE 9-13-1 1), (K 120292, SE 4-13 -12) Laguna Pedicle Screw System (K103748, SE 3-2-11) Denali…
Captiva Spine, Inc.20121
*K103748Laguna Pedicle Screw System
Summary page 1
…CapLOX II Pedicle Screw System (Ki 11115, SE 9-13-1 1), (K 120292, SE 4-13 -12) Laguna Pedicle Screw System (K103748, SE 3-2-11) Denali Spinal System (K042635, SE 1-10-05) Spherx Pedicle…
Phygen, LLC2011—
*K042635Denali Spine System
Summary page 1
…(K 120292, SE 4-13 -12) Laguna Pedicle Screw System (K103748, SE 3-2-11) Denali Spinal System (K042635, SE 1-10-05) Spherx Pedicle Screw System (K092287, SE 10-6-09) Sextan…
K2m, LLC2005—
*K092287Nuvasive Spherx II - Pedicle Screw System
Summary page 1
…cle Screw System (K103748, SE 3-2-11) Denali Spinal System (K042635, SE 1-10-05) Spherx Pedicle Screw System (K092287, SE 10-6-09) Sextant/CD Horizon MIS System (K121680, SE 7-5-12) Array…
Nuvasive, Inc.2009—
*K121680CD Horizon Spinal System
Summary page 1
…System (K042635, SE 1-10-05) Spherx Pedicle Screw System (K092287, SE 10-6-09) Sextant/CD Horizon MIS System (K121680, SE 7-5-12) Array Spinal System (K061978, SE 8-11-06) Reason for this Submission: This Special 5 1…
Medtronic Sofamor Danek USA, Inc.2012—
*K061978Ebi, L.P.'S Line Extension to the Array Spinal System
Summary page 1
…le Screw System (K092287, SE 10-6-09) Sextant/CD Horizon MIS System (K121680, SE 7-5-12) Array Spinal System (K061978, SE 8-11-06) Reason for this Submission: This Special 5 10(k) involves several changes to the previously cleared CapLOX 11 Syste…
Ebi, L.P.2006—

Also cleared against K111115: 1 other device →

What descends from it? (14)

See all 14

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K131538Caplox II Pedicle Screw System/Towerlox Pedicle Screw SystemCaptiva Spine20136
K152781Adena-Zina SystemShanghai Sanyou Medical Co, Ltd.20165
K162576FORTEZZA Spinal Stabilization SystemOsso Surgical20160

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 8 years and passes through 4 companies; a new generation was cleared every 4 months on median.
  • 18 of the 141 ancestors have a recall of any class.
  • Of its descendants, K131538 (Captiva Spine, 2013) has gone furthest, with 6 descendants of its own.
  • 1 other device also cites its predicate K111115.

How does its category compare?

All MNI devices

MNI Orthosis, Spinal Pedicle Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.

FDA decisions per year · MNI

1in 2017

2007: 202008: 232009: 182010: 162011: 172012: 192013: 142014: 62015: 122016: 72017: 1
2007high 23 (2008) · low 0 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MNI

168in 2016

2007: 82 days median2008: 64 days median2009: 86 days median2010: 74 days median2011: 111 days median2012: 75 days median2013: 77 days median2014: 104 days median2015: 54 days median2016: 168 days median
2007high 168 (2016) · low 54 (2015)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MNI

1in 2018

2007: 262008: 82009: 32010: 12012: 12013: 42015: 12018: 1
2007high 26 (2007) · low 0 (2011)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MNI

80in 2025

2007: 832008: 1082009: 1382010: 1262011: 1462012: 2002013: 8242014: 3012015: 2602016: 1172017: 2472018: 1342019: 1882020: 1152021: 2702022: 2142023: 1222024: 1142025: 80
2007high 824 (2013) · low 80 (2025)2025

MAUDE reports naming product code MNI, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200720822683
200823648108
200918863138
201016741126
2011171110146
201219751200
201314774824
201461040301
201512541260
201671680117
20171—0247
20180—1134
20190—0188
20200—0115
20210—0270
20220—0214
20230—0122
20240—0114
20250—080
20260—0—

What is it indicated for?

The TowerLOX Spinal 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…

Read the full statement (144 words)

The TowerLOX Spinal 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, pseudoarthrosis and failed previous fusion.

In addition, when used as a pedicle screw fixation system, the TowerLOX Spinal 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.

Also cleared against K111115

1 other device cites the same predicate.

  • K120292Caplox II Pedicle Screw SystemCaptiva Spine, Inc. · 20121 recall

More from Captiva Spine

7 FDA decisions under this applicant name. See the company

  • K160020Captiva Spine and CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine · 2016
  • K151116CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine · 2015
  • K141332Captiva Spine SmartLOX Cervical Plate SystemCaptiva Spine · 2015
  • K142586Captiva Spine FuselOX Cervical IBF SystemCaptiva Spine · 2015
  • K131538Caplox II Pedicle Screw System/Towerlox Pedicle Screw SystemCaptiva Spine · 2013

Recent decisions in MNI

The MNI category page

  • K171497Mikron Spinal Fixation SystemMikron Makina Sanayi Ticaret Co., Ltd. · 2017
  • K160731LumFix Spinal Fixation SytemCG Bio Co., Ltd. · 2016
  • K151458Double Medical Universal Spine SystemDouble Medical Technology, Inc. · 2016
  • K153273MySpine Pedicle Screw Placement Guides - LPMedacta International S.A. · 2016
  • K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A. · 2016

https://510kreport.com/device/K122332 · printed Nov 6, 2026

Cite this page

510(k) Report. “K122332: 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/K122332

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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