510(k) Report

FDA applicant

Prosidyan, Inc.

New Providence, NJ12 decisions2014–20250 recalls

FDA records 12 decisions for Prosidyan, Inc. (New Providence, NJ) from 2014 to 2025: 12 510(k) clearances. Most are in product codes MQV (Filler, Bone Void, Calcium Compound) and FMF (Syringe, Piston). Since 2016 its 510(k)s took a median of 73 days from receipt to decision, against 124 for FDA’s reviews in the same codes and years. Its devices cite 31 predicates, 14 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 Prosidyan, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2025

2014: 22015: 22017: 22018: 22022: 12024: 12025: 2
2014high 2 (2014) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

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

Planning a device like Prosidyan, 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?

  • MQVFiller, Bone Void, Calcium Compound10decisions
  • FMFSyringe, Piston2decisions

How long do its 510(k) reviews take?

Since 2016, its 8 510(k)s took a median of 73 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 124 days; 7 of its 8 were faster than that.

Whose devices does it build on?

Its devices cite 31 predicates; 14 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 15 times; 14 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.

  • K180080FIBERGRAFT BG Matrix Bone Graft SubstituteProsidyan, Inc. · 20183cite it
  • K132805BG MorselsProsidyan, Inc. · 20143cite it
  • K141956Fibergraft BG MorselsProsidyan, Inc. · 20143cite it
  • K170306FIBERGRAFT BG Putty Bone Graft SubstituteProsidyan, Inc. · 20171cites it
  • K151154FIBERGRAFT BG MorselsProsidyan, Inc. · 20151cites it
  • K213803FIBERGRAFT Aeridyan Matrix Bone Graft SubstituteProsidyan, Inc. · 20221cites it

What has FDA decided for it lately?

  • K253147FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft Substitute FIBERGRAFT™…Prosidyan, Inc. · 2025
  • K251648GPS Advanced; GPS Advanced CannulaProsidyan, Inc. · 2025
  • K241426GPS Advanced; 5 cc GPS Advanced CannulaProsidyan, Inc. · 2024
  • K213803FIBERGRAFT Aeridyan Matrix Bone Graft SubstituteProsidyan, Inc. · 2022
  • K182670FIBERGRAFT AERIDYAN Matrix Bone Graft SubstituteProsidyan, Inc. · 2018
  • K180080FIBERGRAFT BG Matrix Bone Graft SubstituteProsidyan, Inc. · 2018
  • K171284FIBERGRAFT BG Matrix Bone Graft SubstituteProsidyan, Inc. · 2017
  • K170306FIBERGRAFT BG Putty Bone Graft SubstituteProsidyan, Inc. · 2017

All 12 as Prosidyan, Inc. →