510(k) Report

FDA applicant

Captiva Spine, Inc.

Jupiter, FL15 decisions2009–20201 recall

FDA records 15 decisions for Captiva Spine, Inc. (Jupiter, FL) from 2009 to 2020: 15 510(k) clearances. Most are in product codes MNI (Orthosis, Spinal Pedicle Fixation) and MNH (Orthosis, Spondylolisthesis Spinal Fixation). Since 2016 its 510(k)s took a median of 66 days from receipt to decision, against 93 for FDA’s reviews in the same codes and years. Its devices cite 44 predicates, 13 of them its own earlier devices. 1 recall is linked to its devices.

FDA’s records also spell it “Captiva Spine”.

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

FIG. A — Illustration, orthopedic panel, where it files most

How often FDA has decided Captiva Spine, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2009: 12011: 22012: 32013: 12015: 32016: 12018: 32020: 1
2009high 3 (2012) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

1in 2012

2012: 1
2009high 1 (2012) · low 0 (2009)2026

Class I Class II/III not classified

FIG. 1 — Captiva Spine, Inc. by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Captiva Spine, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • MNIOrthosis, Spinal Pedicle Fixation3decisions
  • MNHOrthosis, Spondylolisthesis Spinal Fixation3decisions
  • MAXIntervertebral Fusion Device With Bone Graft, Lumbar3decisions
  • ODPIntervertebral Fusion Device With Bone Graft, Cervical3decisions
  • NKBThoracolumbosacral Pedicle Screw System2decisions
  • KWQAppliance, Fixation, Spinal Intervertebral Body1decision

How long do its 510(k) reviews take?

Since 2016, its 5 510(k)s took a median of 66 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 93 days; 3 of its 5 were faster than that.

Whose devices does it build on?

Its devices cite 44 predicates; 13 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 20 times; 13 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K092017Pivotec Lumbar Interbody Fusion Device (Lifd)Captiva Spine, Inc. · 20094cite it
  • K131538Caplox II Pedicle Screw System/Towerlox Pedicle Screw SystemCaptiva Spine · 20133cite it
  • K122332Towerlox Pedicle Screw SystemCaptiva Spine · 20123cite it
  • K111115Captiva Spine Caplox II Spinal Fixation SystemCaptiva Spine, Inc. · 20112cite it
  • K151116CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine · 20152cite it
  • K120292Caplox II Pedicle Screw SystemCaptiva Spine, Inc. · 20122cite it

What has FDA decided for it lately?

  • K193270CapLOX II®/TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc. · 2020
  • K181229TirboLOX-C Cervical IBFDCaptiva Spine, Inc. · 2018
  • K180990TirboLOX-L Lumbar IBFDCaptiva Spine, Inc. · 2018
  • K180475CapLOX II® / TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc. · 2018
  • 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

All 8 as Captiva Spine, Inc. →All 7 as Captiva Spine →

What has been recalled?

1 recall linked to its devices; the latest:

  • K120292CapLOX II Final Torque Driver, Indicator is a Pedicle screw spinal system. The CapLOX II…Sep 20, 2012Class II