INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible Glenoid
FDA 510(k) K230831 · Depuy Ireland UC
510(k) numberK230831
Submission
- Device name
- INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible Glenoid
- Applicant
- Depuy Ireland UC
Ringaskiddy, IE - Received
- March 27, 2023
- Decision date
- November 13, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MBF – Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3670
- Specialty
- Orthopedic
- Implant
- Yes
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|---|---|---|---|
| K253592 | Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral…MBF · Traditional | Zimmer, Inc. | 04/13/2026SE |
| K251098 | Identity Revision Humeral StemsMBF · Traditional | Zimmer, Inc. | 08/11/2025SE |
| K250848 | Identity Shoulder SystemMBF · Traditional | Zimmer, Inc. | 07/02/2025SE |
| K240876 | Identity Shoulder SystemMBF · Traditional | Zimmer, Inc. | 06/12/2024SE |
| K233712 | PRIMA Humeral System; PRIMA TT GlenoidMBF · Traditional | Lima Corporate S.P.A. | 01/11/2024SE |
| K231099 | SMR Hybrid Glenoid SystemMBF · Traditional | Lima Corporate S.P.A. | 12/21/2023SE |
| K231516 | INHANCE Shoulder System, Sterile Single Use InstrumentationMBF · Traditional | Depuy Ireland UC | 07/21/2023SE |
| K223876 | SMR Shoulder SystemMBF · Traditional | Lima Corporate S.P.A. | 02/03/2023SE |
| K222427 | PRIMA TT GlenoidMBF · Traditional | Lima Corporate S.P.A. | 10/06/2022SE |
| K213856 | Identity Shoulder SystemMBF · Traditional | Zimmer, Inc. | 09/15/2022SE |
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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 INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible Glenoid cleared by the FDA?
INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible Glenoid (K230831) received a 510(k) decision of Substantially Equivalent on November 13, 2023, 231 days after the submission was received.
What is the product code of K230831?
The FDA product code is MBF – Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented, a Class II (moderate risk) device regulated under 21 CFR 888.3670.