# Blue Ortho

- Location (FDA's records): Meylan, FR
- FDA decisions: 9 (2010–2024): 9 510(k) clearances
- Product codes: OLO (8), HAW (1)
- 510(k) review time since 2016: median 130 days, against 90 for FDA's reviews in the same codes and years (2 of 8 faster)
- Predicates its devices cite: 13 (8 its own); citations of its devices by later devices: 13 (8 its own)
- Recalls linked to its devices: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Praxim Medivision, SA: 1 (https://510kreport.com/company/praxim-medivision)
- Custom Orthopaedic Solutions, Inc.: 1 (https://510kreport.com/company/custom-orthopaedic-solutions)
- Tornier, Inc.: 1 (https://510kreport.com/company/tornier)
- Stryker Leibinger GmbH & Co KG: 1 (https://510kreport.com/company/stryker-leibinger)
- Praxim S.A: 1 (https://510kreport.com/company/praxim-s-a)

## Firms that cite its devices most
- Orthosoft Inc (D/B/A Zimmer Cas): 1 (https://510kreport.com/company/orthosoft-d-b-a-zimmer-cas)
- Blue Belt Technologies, Inc.: 1 (https://510kreport.com/company/blue-belt-technologies)
- Tornier, Inc.: 1 (https://510kreport.com/company/tornier)
- Arthrex, Inc.: 1 (https://510kreport.com/company/arthrex)
- Medacta International S.A.: 1 (https://510kreport.com/company/medacta-international)

## Its most-cited devices
- K213546: ExactechGPS Total Shoulder Application, Equinoxe Planning Software (2022), cited by 4
- K173372: ExactechGPS Total Shoulder Application (2017), cited by 3
- K152764: Exactech GPS (2016), cited by 2
- K162567: ExactechGPS Total Shoulder Application, Equinoxe Planning Software (2017), cited by 1
- K193618: ExactechGPS System (2020), cited by 1
- K213877: ExactechGPS® System (2022), cited by 1

## Recent decisions
- K233299: ExactechGPS® System (Jan 26, 2024)
- K232521: ExactechGPS® Total Ankle Application (Nov 16, 2023)
- K213877: ExactechGPS® System (May 2, 2022)
- K213546: ExactechGPS Total Shoulder Application, Equinoxe Planning Software (Jan 6, 2022)
- K193618: ExactechGPS System (Sep 2, 2020)
- K173372: ExactechGPS Total Shoulder Application (Nov 24, 2017)
- K162567: ExactechGPS Total Shoulder Application, Equinoxe Planning Software (Apr 5, 2017)
- K152764: Exactech GPS (Jul 13, 2016)

Source page: https://510kreport.com/company/blue-ortho