510(k) Report

FDA applicant

Parcus Medical, LLC

Sarasota, FL31 decisions2009–20230 recalls

FDA records 31 decisions for Parcus Medical, LLC (Sarasota, FL) from 2009 to 2023: 31 510(k) clearances. Most are in product codes MBI (Fastener, Fixation, Nondegradable, Soft Tissue) and HWC (Screw, Fixation, Bone). Since 2016 its 510(k)s took a median of 65 days from receipt to decision, against 83 for FDA’s reviews in the same codes and years. Its devices cite 68 predicates, 45 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Parcus Medical”.

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

FDA decisions per year

1in 2023

2009: 52010: 22011: 12012: 22013: 12014: 12015: 12016: 12017: 22019: 62020: 42021: 22022: 22023: 1
2009high 6 (2019) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2009.

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

Planning a device like Parcus Medical, 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?

  • MBIFastener, Fixation, Nondegradable, Soft Tissue23decisions
  • HWCScrew, Fixation, Bone5decisions
  • MAIFastener, Fixation, Biodegradable, Soft Tissue3decisions

How long do its 510(k) reviews take?

Since 2016, its 18 510(k)s took a median of 65 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 83 days; 10 of its 18 were faster than that.

Whose devices does it build on?

Its devices cite 68 predicates; 45 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 59 times; 45 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.

  • K120942Parcus Twist 4 5MM Peek Suture Anchor, Parcus Twist 5.5MM Peek Suture Anchor & Parcus Triple Twist 5.5MM…Parcus Medical, LLC · 20126cite it
  • K133757GFS II Standard, GFS II Large, GFS MimiParcus Medical, LLC · 20145cite it
  • K162198GFS UltimateParcus Medical, LLC · 20164cite it
  • K191783Parcus Synd-EZ TiParcus Medical, LLC · 20193cite it
  • K113730Parcus 35 Knotless Peek CF Push-in Suture Anchors, Parcus 45 Knotless Peek CF Push-in Suture AnchorsParcus Medical, LLC · 20123cite it
  • K111000Parcus 2.0MM / 2.5MM / 3.5MM Miti Titanium Suture AnchorParcus Medical, LLC · 20113cite it

What has FDA decided for it lately?

  • K232513X-Twist Biocomposite Suture AnchorParcus Medical · 2023
  • K221502Parcus Synd-EZ SSParcus Medical, LLC · 2022
  • K221135X-Twist PEEK Suture AnchorParcus Medical, LLC · 2022
  • K212739ActiFlipParcus Medical, LLC · 2021
  • K202662Parcus Titanium Interference ScrewsParcus Medical, LLC · 2021
  • K202259Parcus GFS II and GFS Mini, GFS Naked, GFS Ultimate, GFS BTB, ATLAS, Synd-EZ Ti, Actiflip Naked, Actiflip…Parcus Medical, LLC · 2020
  • K201083Parcus V-lox Titanium Suture Anchors, Parcus Miti Suture AnchorsParcus Medical, LLC · 2020
  • K193295Parcus Knotless PEEK and PEEK CF Push-In Suture AnchorParcus Medical, LLC · 2020

All 28 as Parcus Medical, LLC →All 3 as Parcus Medical →