Data / Medical devices / France / Blue Ortho

Blue Ortho: FDA-registered device maker in Meylan Isere, France, 9 510(k) clearances

Name: Blue Ortho FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Blue Ortho is registered with the FDA (registration 3008027912) in Meylan Isere, France. It lists 4 device types. The FDA files 9 510(k) clearances under its listings, the newest dated January 26, 2024. 3 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3008027912
Address: 22 Chemin du Vieux Chene, Meylan Isere, France, 38240
Owner or operator: BLUE ORTHO (10037278)
Roles: Manufacturer
First device listed: June 29, 2011
Registered through: 2026
Brand names listed: Blue Ortho, ExactechGPS System, ExactechGPS Total Shoulder Application, ExactechGPS® System, ExactechGPS® Total Ankle Application, ExactechGPS® Total Shoulder Application

Devices it lists

Device	Product code	Class	Role	Source
Neurological Stereotaxic Instrument	HAW	2	Manufacturer	accessdata.fda.gov
Orthopedic Stereotaxic Instrument	OLO	2	Manufacturer	accessdata.fda.gov
System, Digital Image Communications, Radiological	LMD	1	Manufacturer	accessdata.fda.gov
System, Image Processing, Radiological	LLZ	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
January 26, 2024	K233299	ExactechGPS® System	OLO	Substantially Equivalent	Blue Ortho	accessdata.fda.gov
November 16, 2023	K232521	ExactechGPS® Total Ankle Application	OLO	Substantially Equivalent	Blue Ortho	accessdata.fda.gov
May 2, 2022	K213877	ExactechGPS® System	OLO	Substantially Equivalent	Blue Ortho	accessdata.fda.gov
January 6, 2022	K213546	ExactechGPS Total Shoulder Application, Equinoxe Planning Software	OLO	Substantially Equivalent	Blue Ortho	accessdata.fda.gov
September 2, 2020	K193618	ExactechGPS System	OLO	Substantially Equivalent	Blue Ortho	accessdata.fda.gov
November 24, 2017	K173372	ExactechGPS Total Shoulder Application	OLO	Substantially Equivalent	Blue Ortho	accessdata.fda.gov
April 5, 2017	K162567	ExactechGPS Total Shoulder Application, Equinoxe Planning Software	OLO	Substantially Equivalent	Blue Ortho	accessdata.fda.gov
July 13, 2016	K152764	EXACTECH GPS	HAW	Substantially Equivalent	Blue Ortho	accessdata.fda.gov
October 21, 2010	K100742	EXACTECH GPS	OLO	Substantially Equivalent	Blue Ortho	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
August 30, 2024	95322	Class II	Ongoing	Predict+ is a data-driven, clinical decision support tool that uses machine learning to provide predictions of individual patient outcomes after shoulder replacement surgery	Predict+ is being recalled for lack of pre-market clearance/approval.	accessdata.fda.gov
September 10, 2020	86491	Class II	Terminated	Instructions For Use document of the GPS Trackers.	Appropriateness of the language used in the Tracker reprocessing instruction. Reason is that some Low Temperature sterilization conditions mentioned in the IFUs are approved based on rational documents.	accessdata.fda.gov
September 22, 2019	84713	Class II	Terminated	Blue Ortho TKA Pro v2.1 software installed on the Exactech GPS system -indicated for stereotaxic surgery in Knee Arthroplasty Catalog Reference: L00002	The navigated values displayed when using the LPI instrumentation are incorrect due to software inconsistencies (wrong data loaded).	accessdata.fda.gov

Compare with other makers

Updated October 24, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.