ExactechGPS® Total Ankle Application
FDA 510(k) K232521 · Blue Ortho
510(k) numberK232521
Submission
- Device name
- ExactechGPS® Total Ankle Application
- Applicant
- Blue Ortho
Meylan, FR - Received
- August 18, 2023
- Decision date
- November 16, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OLO – Orthopedic Stereotaxic Instrument
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.4560
- Specialty
- Neurology
Stereotaxic guidance during orthopedic surgery procedures. Indicated for Orthopedic joint or spine surgery. Neurological stereotaxic instruments are classified under product code HAW.
Other 510(k)s with product code OLO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262506 | Remex Spine Surgery Navigation - Universal InstrumentsOLO · Special | Remex Medical Corp. | 08/20/2026SE |
| K261410 | Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration…OLO · Traditional | Suite 201, National Innovation Centre | 07/30/2026SE |
| K261205 | SPINEART Navigation Instrument SystemOLO · Traditional | Spineart SA | 07/29/2026SE |
| K262121 | Ion-L Navigated InstrumentsOLO · Special | SurGenTec, LLC | 07/24/2026SE |
| K261024 | TMINI Miniature Robotic SystemOLO · Traditional | THINK Surgical, Inc. | 07/24/2026SE |
| K261113 | Op.n Spine Navigation and Robotic GuidanceOLO · Traditional | Ecential Robotics | 07/22/2026SE |
| K261852 | OTS HipOLO · Special | Ortoma AB | 07/01/2026SE |
| K253921 | VERTICALE® Navigation InstrumentsOLO · Traditional | Silony Medical GmbH | 06/26/2026SE |
| K260480 | VELYS Robotic-Assisted SolutionOLO · Traditional | Depuy Ireland UC | 06/25/2026SE |
| K260369 | Dynamis Robotic Surgical SystemOLO · Traditional | LEM Surgical AG | 06/20/2026SE |
More from LEM Surgical AG
| 510(k) | Device | Decision |
|---|---|---|
| K233299 | ExactechGPS® SystemOLO · Traditional | 01/26/2024SE |
| K213877 | ExactechGPS® SystemOLO · Traditional | 05/02/2022SE |
| K213546 | ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareOLO · Traditional | 01/06/2022SE |
| K193618 | ExactechGPS SystemOLO · Traditional | 09/02/2020SE |
| K173372 | ExactechGPS Total Shoulder ApplicationOLO · Special | 11/24/2017SE |
| K162567 | ExactechGPS Total Shoulder Application, Equinoxe Planning SoftwareOLO · Traditional | 04/05/2017SE |
| K152764 | Exactech GPSHAW · Traditional | 07/13/2016SE |
| K100742 | Exactech GPSOLO · Traditional | 10/21/2010SE |
Questions and answers
When was ExactechGPS® Total Ankle Application cleared by the FDA?
ExactechGPS® Total Ankle Application (K232521) received a 510(k) decision of Substantially Equivalent on November 16, 2023, 90 days after the submission was received.
What is the product code of K232521?
The FDA product code is OLO – Orthopedic Stereotaxic Instrument, a Class II (moderate risk) device regulated under 21 CFR 882.4560.