Genesys Spine Sacroiliac Joint Fusion System with Navigation
FDA 510(k) K233595 · Genesys Spine
510(k) numberK233595
Submission
- Device name
- Genesys Spine Sacroiliac Joint Fusion System with Navigation
- Applicant
- Genesys Spine
Austin, TX, US - Received
- November 8, 2023
- Decision date
- March 29, 2024
- 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 |
|---|---|---|
| K252322 | SIros-X SystemOUR · Traditional | 10/22/2025SE |
| K242483 | Genesys Spine AIS-C II Cervical Interbody Fusion SystemOVE · Traditional | 02/07/2025SE |
| K233594 | Genesys Spine 3DP AIS-C II Cervical Interbody SystemOVE · Special | 12/13/2023SE |
| K220096 | Genesys Spine 3DP Lumbar Interbody SystemMAX · Special | 03/09/2022SE |
| K191489 | Genesys Spine 3DP Cervical Interbody SystemOVE · Traditional | 01/08/2020SE |
| K182987 | Genesys Spine 3DP Lumbar Interbody SystemMAX · Traditional | 12/12/2019SE |
| K192678 | Genesys Spine Binary® Lumbar Plate SystemKWQ · Special | 10/24/2019SE |
| K191748 | Genesys Spine Sacroiliac Joint Fusion SystemOUR · Traditional | 09/26/2019SE |
| K192076 | Binary® Anterior Cervical Plate SystemKWQ · Special | 08/29/2019SE |
| K181295 | Genesys Spine AIS-C Cervical Stand-Alone SystemOVE · Traditional | 08/29/2018SE |
Questions and answers
When was Genesys Spine Sacroiliac Joint Fusion System with Navigation cleared by the FDA?
Genesys Spine Sacroiliac Joint Fusion System with Navigation (K233595) received a 510(k) decision of Substantially Equivalent on March 29, 2024, 142 days after the submission was received.
What is the product code of K233595?
The FDA product code is OLO – Orthopedic Stereotaxic Instrument, a Class II (moderate risk) device regulated under 21 CFR 882.4560.