510(k) Report

FDA applicant

Ctl Medical Corporation

Addison, TX14 decisions2017–20240 recalls

FDA records 14 decisions for Ctl Medical Corporation (Addison, TX) from 2017 to 2024: 14 510(k) clearances. Most are in product codes MAX (Intervertebral Fusion Device With Bone Graft…) and ODP (Intervertebral Fusion Device With Bone Graft…). Since 2016 its 510(k)s took a median of 263 days from receipt to decision, against 100 for FDA’s reviews in the same codes and years. Its devices cite 39 predicates, 9 of them its own earlier devices. No recall is linked to its devices.

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 Ctl Medical Corporation’s devices, and how often a recall has named them.

FDA decisions per year

2in 2024

2017: 12018: 42020: 12022: 42023: 22024: 2
2017high 4 (2018) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2017.

FIG. 1 — Ctl Medical Corporation by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

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Which product codes does it file in?

  • MAXIntervertebral Fusion Device With Bone Graft, Lumbar4decisions
  • ODPIntervertebral Fusion Device With Bone Graft, Cervical4decisions
  • KWQAppliance, Fixation, Spinal Intervertebral Body2decisions
  • NKBThoracolumbosacral Pedicle Screw System1decision
  • OURSacroiliac Joint Fixation1decision
  • OVEIntervertebral Fusion Device With Integrated Fixation, Cervical1decision

Also: OLO (1).

How long do its 510(k) reviews take?

Since 2016, its 14 510(k)s took a median of 263 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 100 days; 2 of its 14 were faster than that.

Whose devices does it build on?

Its devices cite 39 predicates; 9 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 10 times; 9 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.

  • K162682MATISSE Anterior Cervical Interbody Fusion Cage SystemCtl Medical Corporation · 20174cite it
  • K192863MONDRIAN Lumbar Interbody Fusion Cage SystemCtl Medical Corporation · 20202cite it
  • K172212MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEK™Ctl Medical Corporation · 20181cites it
  • K213641MONDRIAN ALIF Cage with Supplementary Fixation PlateCtl Medical Corporation · 20221cites it
  • K172788MONET™ Anterior Cervical Interbody Fusion Cage SystemCtl Medical Corporation · 20181cites it
  • K182151MONET Anterior Cervical Interbody Fusion Cage System with Supplementary Fixation PlateCtl Medical Corporation · 20181cites it

What has FDA decided for it lately?

  • K233947KLIMT™ Expandable Lumbar Interbody Fusion (LIF) Cage SystemCtl Medical Corporation · 2024
  • K231715MONDRIAN™ Anterior Lumbar Plate SystemCtl Medical Corporation · 2024
  • K231359RODIN™ Expandable Lumbar Cage SystemCtl Medical Corporation · 2023
  • K220513NITRO Interbody Fusion Cage System FamilyCtl Medical Corporation · 2023
  • K220334MONET Anterior Cervical Plate SystemCtl Medical Corporation · 2022
  • K211785CASSATT™ SIJ Fixation SystemCtl Medical Corporation · 2022
  • K213641MONDRIAN ALIF Cage with Supplementary Fixation PlateCtl Medical Corporation · 2022
  • K213491Universal Pilot Guidance Instrument SystemCtl Medical Corporation · 2022

All 14 as Ctl Medical Corporation →