510(k) Report

FDA applicant

Orthosensor, Inc.

Dania Beach, FL8 decisions2009–20207 recalls

FDA records 8 decisions for Orthosensor, Inc. (Dania Beach, FL) from 2009 to 2020: 8 510(k) clearances. All are in product code ONN (Intraoperative Orthopedic Joint Assessment Aid). Since 2016 its 510(k)s took a median of 100 days from receipt to decision, against 100 for FDA’s reviews in the same codes and years. Its devices cite 10 predicates, 8 of them its own earlier devices. 7 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, neurology panel, where it files most

How often FDA has decided Orthosensor, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

3in 2020

2009: 12013: 22016: 12018: 12020: 3
2009high 3 (2020) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

6in 2018

2014: 12018: 6
2009high 6 (2018) · low 0 (2009)2026

Class I Class II/III not classified

FIG. 1 — Orthosensor, Inc. by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Orthosensor, 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?

  • ONNIntraoperative Orthopedic Joint Assessment Aid8decisions

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 100 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 100 days; 1 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 10 predicates; 8 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 13 times; 8 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.

  • K180459VERASENSE for Zimmer Biomet PersonaOrthosensor, Inc. · 20184cite it
  • K150372VERASENSE Knee SystemOrthosensor, Inc. · 20163cite it
  • K130380Orthosensor Knee BalancerOrthosensor, Inc. · 20132cite it
  • K090474Orthorex Intra-Operative Load SensorOrthosensor, Inc. · 20092cite it
  • K193580VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Left, VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Right…Orthosensor, Inc. · 20201cites it
  • K131767Orthosensor Knee Balancer, Verasense Knee SystemOrthosensor, Inc. · 20131cites it

What has FDA decided for it lately?

  • K200587VERASENSE for Exactech Equinoxe Size 38 mm, VERASENSE for Exactech Equinoxe Size 42 mm, LinkStation MINI…Orthosensor, Inc. · 2020
  • K200665VERASENSE for Stryker TriathlonOrthosensor, Inc. · 2020
  • K193580VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Left, VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Right…Orthosensor, Inc. · 2020
  • K180459VERASENSE for Zimmer Biomet PersonaOrthosensor, Inc. · 20186 recalls
  • K150372VERASENSE Knee SystemOrthosensor, Inc. · 2016
  • K131767Orthosensor Knee Balancer, Verasense Knee SystemOrthosensor, Inc. · 2013
  • K130380Orthosensor Knee BalancerOrthosensor, Inc. · 20131 recall
  • K090474Orthorex Intra-Operative Load SensorOrthosensor, Inc. · 2009

All 8 as Orthosensor, Inc. →

What has been recalled?

7 recalls linked to its devices; the latest:

  • K180459OrthoSensor VERASENSE for Zimmer Biomet Persona CR G-H/7-12 Left, REF ZBH-PSNCRGH712-L.Jul 12, 2018Class II
  • K180459OrthoSensor VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Right, REF ZBH-PSNCRCD39-R.Jul 12, 2018Class II
  • K180459OrthoSensor VERASENSE for Zimmer Biomet Persona CR G-H/7-12 Right, REF ZBH-PSNCRGH712-R.Jul 12, 2018Class II
  • K180459OrthoSensor VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Left, REF ZBH-PSNCREF311-L.Jul 12, 2018Class II
  • K180459OrthoSensor VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Right, REF ZBH-PSNCREF311-R.Jul 12, 2018Class II
  • K180459OrthoSensor VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Left, REF ZBH-PSNCRCD39-L.Jul 12, 2018Class II