VELYS Hip Navigation
FDA 510(k) K253551 · Depuy Ireland UC
510(k) numberK253551
Submission
- Device name
- VELYS Hip Navigation
- Applicant
- Depuy Ireland UC
Ringaskiddy, Co. Cork, IE - Received
- November 14, 2025
- Decision date
- March 6, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QIH – Automated Radiological Image Processing Software
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 892.2050
- Specialty
- Radiology
To provide automated radiological image processing and analysis tools. Software implementing artificial intelligence including nonadaptive machine learning algorithms trained with clinical and/or artificial data. In these devices, the algorithm training data typically impacts device performance. Adaptive AI algorithms are not within scope of this product code.
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| K260480 | VELYS Robotic-Assisted SolutionOLO · 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 |
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| 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 |
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Questions and answers
When was VELYS Hip Navigation cleared by the FDA?
VELYS Hip Navigation (K253551) received a 510(k) decision of Substantially Equivalent on March 6, 2026, 112 days after the submission was received.
What is the product code of K253551?
The FDA product code is QIH – Automated Radiological Image Processing Software, a Class II (moderate risk) device regulated under 21 CFR 892.2050.