VELYS Robotic-Assisted Solution
FDA 510(k) K260480 · Depuy Ireland UC
510(k) numberK260480
Submission
- Device name
- VELYS Robotic-Assisted Solution
- Applicant
- Depuy Ireland UC
Ringaskiddy, Co. Cork, IE - Received
- February 13, 2026
- Decision date
- June 25, 2026
- 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 |
| K260369 | Dynamis Robotic Surgical SystemOLO · Traditional | LEM Surgical AG | 06/20/2026SE |
| K261665 | CORUS Navigation System-GNOLO · Special | Providence Medical Technology, Inc. | 06/18/2026SE |
More from Providence Medical Technology, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K261458 | ATTUNE Total Knee System; ATTUNE Cementless Knee SystemJWH · Traditional | 06/25/2026SE |
| K260536 | Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone CementKWL · Traditional | 05/15/2026SE |
| K253624 | INHANCE Reverse Shoulder SystemPHX · Traditional | 03/11/2026SE |
| K253551 | VELYS Hip NavigationQIH · Traditional | 03/06/2026SE |
| K253197 | ATTUNE Total Knee System; ATTUNE Revision Sleeve LPS Femoral AdaptorsJWH · Traditional | 11/19/2025SE |
| K251292 | RECLAIM Monobloc Revision Femoral StemLZO · Special | 05/23/2025SE |
| K243977 | EMPHASYS Acetabular SystemLPH · Special | 01/22/2025SE |
| K243248 | Inhance IntactPKC · Traditional | 12/23/2024SE |
| K242871 | ATTUNE Revision Hinge KneeKRO · Traditional | 11/21/2024SE |
| K242084 | EMPHASYS Acetabular Shell with RapiTite HALPH · Traditional | 10/07/2024SE |
Questions and answers
When was VELYS Robotic-Assisted Solution cleared by the FDA?
VELYS Robotic-Assisted Solution (K260480) received a 510(k) decision of Substantially Equivalent on June 25, 2026, 132 days after the submission was received.
What is the product code of K260480?
The FDA product code is OLO – Orthopedic Stereotaxic Instrument, a Class II (moderate risk) device regulated under 21 CFR 882.4560.