510(k) Report

FDA applicant

Conventus Orthopaedics, Inc.

Maple Grove, MN6 decisions2013–20212 recalls

FDA records 6 decisions for Conventus Orthopaedics, Inc. (Maple Grove, MN) from 2013 to 2021: 6 510(k) clearances. Most are in product codes HRS (Plate, Fixation, Bone) and HSB (Rod, Fixation, Intramedullary And Accessories). Its devices cite 15 predicates, 7 of them its own earlier devices. 2 recalls are linked to its devices.

FDA’s records also spell it “Conventus Orthopaedics”, “Conventus Orthopaedics, 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 Conventus Orthopaedics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2013: 12014: 12015: 22016: 12021: 1
2013high 2 (2015) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

1in 2023

2021: 12023: 1
2013high 1 (2021) · low 0 (2013)2026

Class I Class II/III not classified

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

Planning a device like Conventus Orthopaedics, 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?

  • HRSPlate, Fixation, Bone4decisions
  • HSBRod, Fixation, Intramedullary And Accessories1decision
  • JDSNail, Fixation, Bone1decision

Whose devices does it build on?

Its devices cite 15 predicates; 7 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 9 times; 7 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.

  • K102689Conventus Orthopaedics Fracture Fixation SystemConventus Orthopaedics · 20134cite it
  • K131552Conventus DRSConventus Orthopaedics · 20142cite it
  • K202858Flex-ThreadTM Distal Fibula Intramedullary Nail SystemConventus Orthopaedics, LLC · 20212cite it
  • K151379Conventus PRS SystemConventus Orthopaedics, Inc. · 20151cites it

What has FDA decided for it lately?

  • K202858Flex-ThreadTM Distal Fibula Intramedullary Nail SystemConventus Orthopaedics, LLC · 20212 recalls
  • K161048Conventus Orthopaedics Ulna Fixation SystemConventus Orthopaedics, Inc. · 2016
  • K151379Conventus PRS SystemConventus Orthopaedics, Inc. · 2015
  • K141737Conventus PHS SystemConventus Orthopaedics, Inc. · 2015
  • K131552Conventus DRSConventus Orthopaedics · 2014
  • K102689Conventus Orthopaedics Fracture Fixation SystemConventus Orthopaedics · 2013

All 3 as Conventus Orthopaedics, Inc. →All 2 as Conventus Orthopaedics →The one decision as Conventus Orthopaedics, LLC →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K202858Coventus Flower Orthopedics Flex-Thread TM 3.2mm Cannulated Reamer-used to ream and…Aug 29, 2023Class II
  • K202858Flex-Thread Inserter Shaft intended for Fibula intramedullary-intended to be used with…Nov 2, 2021Class II