510(k) Report

FDA applicant

Paradigm Spine, LLC

Washington, DC16 decisions2008–20221 recall

FDA records 16 decisions for Paradigm Spine, LLC (Washington, DC) from 2008 to 2022: 16 510(k) clearances. Most are in product codes NQP (Posterior Metal/Polymer Spinal System, Fusion) and NKB (Thoracolumbosacral Pedicle Screw System). Since 2016 its 510(k)s took a median of 128 days from receipt to decision, against 106 for FDA’s reviews in the same codes and years. Its devices cite 51 predicates, 23 of them its own earlier devices. 1 recall is linked to its devices.

FDA’s records also spell it “Paradigm Spine”, “Paradigm Spine GmbH”.

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 Paradigm Spine, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2008: 42009: 32010: 22012: 32016: 12020: 22022: 1
2008high 4 (2008) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

1in 2012

2012: 1
2008high 1 (2012) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Paradigm Spine, LLC by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Paradigm Spine, LLC’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?

  • NQPPosterior Metal/Polymer Spinal System, Fusion5decisions
  • NKBThoracolumbosacral Pedicle Screw System3decisions
  • PEKSpinous Process Plate2decisions
  • KWPAppliance, Fixation, Spinal Interlaminal2decisions
  • ODPIntervertebral Fusion Device With Bone Graft, Cervical1decision
  • MNHOrthosis, Spondylolisthesis Spinal Fixation1decision

Also: MNI (1), MAX (1).

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 128 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 106 days; 1 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 51 predicates; 23 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 30 times; 23 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.

  • K080241DDS Stabilization SystemParadigm Spine, LLC · 20085cite it
  • K090408Modification to: DSS Stabilization SystemParadigm Spine, LLC · 20094cite it
  • K090099DSS Stabilization SystemParadigm Spine, LLC · 20094cite it
  • K071668Orthobiom Spinal SystemParadigm Spine · 20083cite it
  • K093438Paradigm Interspinous Fusion PlateParadigm Spine, LLC · 20103cite it
  • K153302coflex-IFParadigm Spine, LLC · 20162cite it

What has FDA decided for it lately?

  • K213493Fortilink with TiPlus TechnologyParadigm Spine · 2022
  • K201453Fortilink Cages with TiPlus TechnologyParadigm Spine GmbH · 2020
  • K201704CoFix SystemParadigm Spine GmbH · 2020
  • K153302coflex-IFParadigm Spine, LLC · 2016
  • K120491DSS Stabilization System-RigidParadigm Spine, LLC · 2012
  • K112595Coflex-FParadigm Spine, LLC · 2012
  • K113625DSS Stabilization SystemParadigm Spine, LLC · 2012
  • K093438Paradigm Interspinous Fusion PlateParadigm Spine, LLC · 20101 recall

All 11 as Paradigm Spine, LLC →All 3 as Paradigm Spine →All 2 as Paradigm Spine GmbH →

What has been recalled?

1 recall linked to its devices; the latest:

  • K093438Spine Frontier Inspan compressors Part Number: 11-60004. Inspan compressors provide…Aug 28, 2012Class II

Other applicant names beginning “Paradigm”

FDA records each applicant name separately; these may or may not be the same firm.

Paradigm Medical Industries, Inc. 10Paradigm Medical, Inc. 3Paradigm Trex, LLC 1Paradigm Lasers, Inc. 1