Blue Ortho
Meylan Isere, FR
BLUE ORTHO appears in FDA device records in Meylan Isere, FR. FDA records list 9 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 3 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 9 510(k) clearances for Blue Ortho between 2010 and 2024. The busiest year on record is 2017, with 2. The most recent is 2024, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2010 | 1 |
| 2016 | 1 |
| 2017 | 2 |
| 2020 | 1 |
| 2022 | 2 |
| 2023 | 1 |
| 2024 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K233299 | ExactechGPS® System | OLO | Substantially Equivalent | |
| K232521 | ExactechGPS® Total Ankle Application | OLO | Substantially Equivalent | |
| K213877 | ExactechGPS® System | OLO | Substantially Equivalent | |
| K213546 | ExactechGPS Total Shoulder Application, Equinoxe Planning Software | OLO | Substantially Equivalent | |
| K193618 | ExactechGPS System | OLO | Substantially Equivalent | |
| K173372 | ExactechGPS Total Shoulder Application | OLO | Substantially Equivalent | |
| K162567 | ExactechGPS Total Shoulder Application, Equinoxe Planning Software | OLO | Substantially Equivalent | |
| K152764 | EXACTECH GPS | HAW | Substantially Equivalent | |
| K100742 | EXACTECH GPS | OLO | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3008027912 | 3008027912 | BLUE ORTHO | 22 Chemin du Vieux Chene, Meylan Isere 38240 FR | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0209-2025 | 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. | Class II | Open, Classified | |
| Z-0288-2021 | 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. | Class II | Terminated | |
| Z-1149-2020 | 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). | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain