510(k) Report

FDA applicant

SurGenTec, LLC

Boca Raton, FL33 decisions2017–20260 recalls

FDA records 33 decisions for SurGenTec, LLC (Boca Raton, FL) from 2017 to 2026: 33 510(k) clearances. Most are in product codes OUR (Sacroiliac Joint Fixation) and MRW (System, Facet Screw Spinal Device). Since 2016 its 510(k)s took a median of 93 days from receipt to decision, against 103 for FDA’s reviews in the same codes and years. Its devices cite 59 predicates, 30 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Surgentec”.

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

FDA decisions per year

4in 2025

2017: 12018: 12019: 12020: 32022: 12023: 42024: 92025: 42026 (partial year): 9
2017high 9 (2024) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2017.

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

Planning a device like SurGenTec, 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?

  • OURSacroiliac Joint Fixation8decisions
  • MRWSystem, Facet Screw Spinal Device6decisions
  • FMFSyringe, Piston6decisions
  • MQVFiller, Bone Void, Calcium Compound5decisions
  • OLOOrthopedic Stereotaxic Instrument3decisions
  • KNWInstrument, Biopsy2decisions

Also: PDQ (1), GZT (1), HRX (1).

How long do its 510(k) reviews take?

Since 2016, its 32 510(k)s took a median of 93 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 103 days; 17 of its 32 were faster than that.

Whose devices does it build on?

Its devices cite 59 predicates; 30 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 38 times; 30 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.

  • K170675Graftgun Universal Graft Delivery SystemSurGenTec, LLC · 20177cite it
  • K211855Ion Facet Screw SystemSurGenTec, LLC · 20226cite it
  • K180937Graftgun Universal Graft Delivery SystemSurGenTec, LLC · 20184cite it
  • K230446TiLink-L SI Joint Fusion SystemSurGenTec, LLC · 20232cite it
  • K240720TiLink-P SI Joint Fusion SystemSurGenTec, LLC · 20242cite it
  • K240086Ion 3DSurGenTec, LLC · 20242cite it

What has FDA decided for it lately?

  • K263208Vantage Lumbar Decompression KitSurGenTec, LLC · 2026
  • K252995Durashield Device KitSurGenTec, LLC · 2026
  • K262581GraftGun Universal Graft Delivery System (GDS®)SurGenTec, LLC · 2026
  • K261381TiLink-L™ SI Joint Fusion SystemSurGenTec, LLC · 2026
  • K262121Ion-L Navigated InstrumentsSurGenTec, LLC · 2026
  • K261209Ion-LSurGenTec, LLC · 2026
  • K260329Ion-C Navigation InstrumentsSurGenTec, LLC · 2026
  • K253604TiLink-L Navigation InstrumentsSurGenTec, LLC · 2026

All 30 as SurGenTec, LLC →All 3 as Surgentec →