CORAIL Cemented Femoral Stem
FDA 510(k) K231526 · Depuy Ireland UC
510(k) numberK231526
Submission
- Device name
- CORAIL Cemented Femoral Stem
- Applicant
- Depuy Ireland UC
Co. Cork, IE - Received
- May 26, 2023
- Decision date
- December 19, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KWY – Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3390
- Specialty
- Orthopedic
- Implant
- Yes
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| K261458 | ATTUNE Total Knee System; ATTUNE Cementless Knee SystemJWH · Traditional | 06/25/2026SE |
| 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 |
| 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 |
Questions and answers
When was CORAIL Cemented Femoral Stem cleared by the FDA?
CORAIL Cemented Femoral Stem (K231526) received a 510(k) decision of Substantially Equivalent on December 19, 2023, 207 days after the submission was received.
What is the product code of K231526?
The FDA product code is KWY – Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented, a Class II (moderate risk) device regulated under 21 CFR 888.3390.