510(k) Report

FDA applicant

Paragon 28, Inc.

Englewood, CO61 decisions2014–20268 recalls

FDA records 61 decisions for Paragon 28, Inc. (Englewood, CO) from 2014 to 2026: 61 510(k) clearances. Most are in product codes MBI (Fastener, Fixation, Nondegradable, Soft Tissue) and HSB (Rod, Fixation, Intramedullary And Accessories). Since 2016 its 510(k)s took a median of 72 days from receipt to decision, against 94 for FDA’s reviews in the same codes and years. Its devices cite 126 predicates, 60 of them its own earlier devices. 8 recalls are linked to its devices.

FDA’s records also spell it “Paragon 28”.

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 Paragon 28, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

6in 2025

2014: 12015: 22017: 42018: 22019: 72020: 72021: 82022: 52023: 72024: 62025: 62026 (partial year): 6
2014high 8 (2021) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

1in 2025

2017: 12018: 12022: 22023: 32025: 1
2014high 3 (2023) · low 0 (2014)2026

Class I Class II/III not classified

FIG. 1 — Paragon 28, Inc. by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Paragon 28, Inc.’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 Tissue13decisions
  • HSBRod, Fixation, Intramedullary And Accessories8decisions
  • HSNProsthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer8decisions
  • HWCScrew, Fixation, Bone8decisions
  • HRSPlate, Fixation, Bone8decisions
  • KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component6decisions

Also: JDR (4), HTY (3), PLF (2), KTW (1).

How long do its 510(k) reviews take?

Since 2016, its 51 510(k)s took a median of 72 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 94 days; 31 of its 51 were faster than that.

Whose devices does it build on?

Its devices cite 126 predicates; 60 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 94 times; 60 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.

  • K140397Paralock Plating System / Tuffnek ScrewParagon 28 · 20147cite it
  • K211002Grappler Suture Anchor SystemParagon 28, Inc. · 20216cite it
  • K203011Monster Screw SystemParagon 28, Inc. · 20206cite it
  • K190365Baby Gorilla/Gorilla Plating SystemParagon 28, Inc. · 20196cite it
  • K190586Monster® Screw SystemParagon 28, Inc. · 20196cite it
  • K203511Baby Gorilla/Gorilla Plating SystemParagon 28, Inc. · 20206cite it

What has FDA decided for it lately?

  • K261120APEX 3D S Diamond TibiaParagon 28, Inc. · 2026
  • K262722Primal K-Wire (P99-193-1410)Paragon 28, Inc. · 2026
  • K261121Megalodon Dynamic Compression SystemParagon 28, Inc. · 2026
  • K262047Grappler Suture Anchor SystemParagon 28, Inc. · 2026
  • K253886Grappler Suture Anchor PCFD Tether SystemParagon 28, Inc. · 2026
  • K253591Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc. · 2026
  • K253613Monkey Rings External Ring Fixation SystemParagon 28, Inc. · 2025
  • K252106External Fixation Mini Rail SystemParagon 28, Inc. · 2025

All 54 as Paragon 28, Inc. →All 7 as Paragon 28 →

What has been recalled?

8 recalls linked to its devices; the latest:

  • K234128Phantom Fibula Nail, 2.8mm x 130mm, Right, Ti, Fibula Nail, REF: P36-128-130R-SOct 13, 2025Class II
  • K210869Phantom TTC Nail, TTC Nail, 11.5 X 250mm, RIGHT, REF: P31-615-250RDec 21, 2023Class II
  • K210869Phantom TTC Nail, TTC Nail, 10.0 X 150mm, RIGHT , REF: P31-600-175LDec 21, 2023Class II
  • K210869Phantom TTC Nail, 10.0 X 200mm, RightDec 21, 2023Class II
  • K211002Grappler Suture Anchor, Titanium, 3.0 x 10mm, Sterile Kit, REF: P44-110-3010-SK, for use…Jul 13, 2022Class II
  • K171715HammerTube Implant, 2.75mm, 10¿ Cannulated (Sterile)May 26, 2022Class II

Other applicant names beginning “Paragon”

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

Paragon Vision Sciences 16Paragon Trade Brands, Inc. 14Paragon Diagnostics, Inc. 7Paragon Medical 5Paragon Implant Mfg., LLC 5Paragon Optical Co. 2Paragon Medical and Scientific, Inc. 1Paragon Bioteck, Inc. 1