510(k) Report

FDA applicant

Republic Spine, LLC

Boca Raton, FL7 decisions2015–20230 recalls

FDA records 7 decisions for Republic Spine, LLC (Boca Raton, FL) from 2015 to 2023: 7 510(k) clearances. Most are in product codes NKB (Thoracolumbosacral Pedicle Screw System) and ODP (Intervertebral Fusion Device With Bone Graft…). Since 2016 its 510(k)s took a median of 148 days from receipt to decision, against 82 for FDA’s reviews in the same codes and years. Its devices cite 14 predicates, 3 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 Republic Spine, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2015: 12018: 12019: 22021: 22023: 1
2015high 2 (2019) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2015.

FIG. 1 — Republic Spine, LLC by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Republic 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?

  • NKBThoracolumbosacral Pedicle Screw System3decisions
  • ODPIntervertebral Fusion Device With Bone Graft, Cervical1decision
  • MAXIntervertebral Fusion Device With Bone Graft, Lumbar1decision
  • MNHOrthosis, Spondylolisthesis Spinal Fixation1decision
  • OLOOrthopedic Stereotaxic Instrument1decision

How long do its 510(k) reviews take?

Since 2016, its 6 510(k)s took a median of 148 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 82 days; 3 of its 6 were faster than that.

Whose devices does it build on?

Its devices cite 14 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 times; 3 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.

  • K181495Republic Spine Dark Star Spinal SystemRepublic Spine, LLC · 20181cites it
  • K150283Republic Spine Dark Star Spinal SystemRepublic Spine, LLC · 20151cites it
  • K201420Republic Spine Dark Star Spinal SystemRepublic Spine, LLC · 20211cites it
  • K223096Dark Star Deformity Pedicle Screw SystemRepublic Spine, LLC · 20231cites it

What has FDA decided for it lately?

  • K223096Dark Star Deformity Pedicle Screw SystemRepublic Spine, LLC · 2023
  • K212028Dark Star Navigation Instrument SystemRepublic Spine, LLC · 2021
  • K201420Republic Spine Dark Star Spinal SystemRepublic Spine, LLC · 2021
  • K190398Republic Spine Restore Intervertebral Body Fusion SystemRepublic Spine, LLC · 2019
  • K190889Republic Spine Restore Cervical Interbody Fusion SystemRepublic Spine, LLC · 2019
  • K181495Republic Spine Dark Star Spinal SystemRepublic Spine, LLC · 2018
  • K150283Republic Spine Dark Star Spinal SystemRepublic Spine, LLC · 2015

All 7 as Republic Spine, LLC →