510(k) Report

FDA applicant

Bioventus, LLC

Durham, NC9 decisions1994–20263 recalls

FDA records 9 decisions for Bioventus, LLC (Durham, NC) from 1994 to 2026: 7 510(k) clearances and 2 original PMA approvals. Most are in product codes MQV (Filler, Bone Void, Calcium Compound) and GZF (Stimulator, Peripheral Nerve, Implanted (Pain…). Since 2016 its 510(k)s took a median of 153 days from receipt to decision, against 127 for FDA’s reviews in the same codes and years. Its devices cite 13 predicates, 0 of them its own earlier devices. 3 recalls are linked to its devices.

FDA’s records also spell it “Bioventus”.

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

FDA decisions per year

2in 2025

2017: 22020: 12023: 12024: 12025: 22026 (partial year): 1
2007high 2 (2017) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2020

2009: 22020: 1
2007high 2 (2009) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Bioventus, LLC by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Bioventus, 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?

  • MQVFiller, Bone Void, Calcium Compound3decisions
  • GZFStimulator, Peripheral Nerve, Implanted (Pain Relief)3decisions
  • LOFStimulator, Bone Growth, Non-Invasive1decision
  • FMFSyringe, Piston1decision
  • MOZAcid, Hyaluronic, Intraarticular1decision

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 153 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 127 days; 1 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 13 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 0 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.

  • K233490SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE PuttyBioventus, LLC · 20231cites it

What has FDA decided for it lately?

  • K253877StimTrial Neuromodulation SystemBioventus, LLC · 2026
  • K243782StimTrial Neuromodulation SystemBioventus, LLC · 2025
  • K243678TalisMann Neuromodulation SystemBioventus, LLC · 2025
  • K233368Allograft Delivery Device (OFAC-C)Bioventus, LLC · 2024
  • K233490SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE PuttyBioventus, LLC · 2023
  • K193513SIGNAFUSE Bioactive Bone GraftBioventus · 2020
  • P170007DurolaneBioventus, LLC · 2017
  • K162860MCS Bone GraftBioventus, LLC · 2017

All 8 as Bioventus, LLC →The one decision as Bioventus →

What has been recalled?

3 recalls linked to its devices; the latest:

  • P900009EXOGEN Ultrasound Coupling GelDec 17, 2020Class II
  • P900009Exogen 4000+ Ultrasound Bone Healing System, SAFHS, Part Numbers 71034100 and 71034101…Jun 5, 2009
  • P900009Exogen Express Bone Healing System, SAFHS, Part Numbers 71034200 and 71034140, Rx only…Jun 5, 2009