510(k) Report

FDA applicant

Blue Ortho

Meylan, FR9 decisions2010–20244 recalls

FDA records 9 decisions for Blue Ortho (Meylan, FR) from 2010 to 2024: 9 510(k) clearances. Most are in product codes OLO (Orthopedic Stereotaxic Instrument) and HAW (Neurological Stereotaxic Instrument). Since 2016 its 510(k)s took a median of 130 days from receipt to decision, against 90 for FDA’s reviews in the same codes and years. Its devices cite 13 predicates, 8 of them its own earlier devices. 4 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 Blue Ortho’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2010: 12016: 12017: 22020: 12022: 22023: 12024: 1
2010high 2 (2017) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

1in 2023

2017: 12019: 12020: 12023: 1
2010high 1 (2017) · low 0 (2010)2026

Class I Class II/III not classified

FIG. 1 — Blue Ortho by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • OLOOrthopedic Stereotaxic Instrument8decisions
  • HAWNeurological Stereotaxic Instrument1decision

How long do its 510(k) reviews take?

Since 2016, its 8 510(k)s took a median of 130 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 90 days; 2 of its 8 were faster than that.

Whose devices does it build on?

Its devices cite 13 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.

  • K213546ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho · 20224cite it
  • K173372ExactechGPS Total Shoulder ApplicationBlue Ortho · 20173cite it
  • K152764Exactech GPSBlue Ortho · 20162cite it
  • K162567ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho · 20171cites it
  • K193618ExactechGPS SystemBlue Ortho · 20201cites it
  • K213877ExactechGPS® SystemBlue Ortho · 20221cites it

What has FDA decided for it lately?

  • K233299ExactechGPS® SystemBlue Ortho · 2024
  • K232521ExactechGPS® Total Ankle ApplicationBlue Ortho · 2023
  • K213877ExactechGPS® SystemBlue Ortho · 2022
  • K213546ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho · 20221 recall
  • K193618ExactechGPS SystemBlue Ortho · 20201 recall
  • K173372ExactechGPS Total Shoulder ApplicationBlue Ortho · 20171 recall
  • K162567ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareBlue Ortho · 20171 recall
  • K152764Exactech GPSBlue Ortho · 20161 recall

All 9 as Blue Ortho →

What has been recalled?

4 recalls linked to its devices; the latest:

  • K213546Exactech Shoulder GPS Impactor Handle, Catalog #531-07-05.Jun 5, 2023Class II
  • K193618Instructions For Use document of the GPS Trackers.Sep 10, 2020Class II
  • K152764Blue Ortho TKA Pro v2.1 software installed on the Exactech GPS system -indicated for…Sep 22, 2019Class II
  • K162567Exactech GPS Total Shoulder Application 3.2mm Vix Bit Orthopedic surgical toolJul 11, 2017Class II

Other applicant names beginning “Blue”

FDA records each applicant name separately; these may or may not be the same firm.

Blue Belt Technologies, Inc. 22Blue Sky Bio, LLC 21Blue Ridge Media Co. 11Blue Sky Medical Group Incorporated 4Blue Planet Industries, Inc. 3Blue Torch Medical Technologies 2Blue Sail Medical Co.,Ltd 2Blue X Imaging Srl 2Blue Spark Technologies, Inc. 2Blue & Red Corp. 1Blue Focus 1Blue Gem Sunglasses, Inc. 1