510(k) Report

FDA applicant

Cerapedics, Inc.

Westminster2 decisions2015–20252 recalls

FDA records 2 decisions for Cerapedics, Inc. (Westminster) from 2015 to 2025: 2 original PMA approvals. All are in product code NOX (Filler, Bone Void, Synthetic Peptide). 2 recalls are linked to its devices.

FDA’s records also spell it “Cerapedics, LLC”.

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

FDA decisions per year

1in 2025

2015: 12025: 1
2015high 1 (2015) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

1in 2025

2022: 12025: 1
2015high 1 (2022) · low 0 (2015)2026

Class I Class II/III not classified

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

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Which product codes does it file in?

  • NOXFiller, Bone Void, Synthetic Peptide2decisions

What has FDA decided for it lately?

  • P240001PearlMatrix™ Bone GraftCerapedics, Inc. · 20251 recall
  • P140019I-Factor Peptide Enhanced Bone GraftCerapedics, LLC · 20151 recall

The one decision as Cerapedics, Inc. →The one decision as Cerapedics, LLC →

What has been recalled?

2 recalls linked to its devices; the latest:

  • P240001PearMatrix P-15 Peptide Enhanced Bone Graft Bone Graft, 1.0cc REF: 730-010Dec 29, 2025Class II
  • P140019putty i-FACTOR Peptide Enhanced Bone Graft 1.0cc Syringe REF 700-010, PUTTYApr 14, 2022Class III