510(k) Report

FDA applicant

Vivorte, Inc.

Fort Wayne, IN4 decisions2013–20151 recall

FDA records 4 decisions for Vivorte, Inc. (Fort Wayne, IN) from 2013 to 2015: 4 510(k) clearances. Most are in product codes MBP (Filler, Bone Void, Osteoinduction (W/O Human…) and MQV (Filler, Bone Void, Calcium Compound). Its devices cite 5 predicates, 2 of them its own earlier devices. 1 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 Vivorte, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2015

2013: 22015: 2
2013high 2 (2013) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

1in 2018

2018: 1
2013high 1 (2018) · low 0 (2013)2026

Class I Class II/III not classified

FIG. 1 — Vivorte, Inc. by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Vivorte, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • MBPFiller, Bone Void, Osteoinduction (W/O Human Growth Factor)2decisions
  • MQVFiller, Bone Void, Calcium Compound2decisions

Whose devices does it build on?

Its devices cite 5 predicates; 2 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K130703Vivorte BVFVivorte, Inc. · 20131cites it
  • K131133Vivorte BVF LiteVivorte, Inc. · 20131cites it

What has FDA decided for it lately?

  • K143547Vivorte Trabexus EBVivorte, Inc. · 20151 recall
  • K143549Vivorte TrabexusVivorte, Inc. · 2015
  • K130703Vivorte BVFVivorte, Inc. · 20131 recall
  • K131133Vivorte BVF LiteVivorte, Inc. · 2013

All 4 as Vivorte, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K130703Vivorte Trabexus EB 10 cc Bone Void Filler -Fill bone and/or defect in skeletal system…Sep 9, 2018Class II