INHANCETM Reverse Glenoid Peripheral Posts
FDA 510(k) K221467 · Depuy Ireland UC
510(k) numberK221467
Submission
- Device name
- INHANCETM Reverse Glenoid Peripheral Posts
- Applicant
- Depuy Ireland UC
Ringaskiddy, IE - Received
- May 20, 2022
- Decision date
- August 31, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PHX – Shoulder Prosthesis, Reverse Configuration
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3660
- Specialty
- Orthopedic
- Implant
- Yes
Intended to be used to relieve pain and to replace the glenoid and humeral side of the shoulder joint in order to restore mobility in a grossly rotator cuff deficient joint with severe arthropathy or a previous joint replacement with a grossly rotator cuff deficient joint.
Other 510(k)s with product code PHX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260556 | Veritas Shoulder SystemPHX · Traditional | Restor3D | 07/01/2026SE |
| K261683 | Augment Off-Axis Instrument SystemPHX · Special | Zimmer, Inc. | 06/16/2026SE |
| K260102 | Tornier Perform Reversed Glenoid and Tornier Perform Reversed Augmented Glenoid Shoulder…PHX · Traditional | Stryker Corporation (Tornier, Inc.) | 06/12/2026SE |
| K261016 | MSS - Humeral reverse liners extensionPHX · Traditional | Medacta International, SA | 06/10/2026SE |
| K253992 | Veritas Reverse Total Shoulder SystemPHX · Traditional | Restor3D | 05/07/2026SE |
| K252404 | Comprehensive Reverse Shoulder - HA Glenosphere BaseplatesPHX · Traditional | Biomet Orthopedics | 04/15/2026SE |
| K260583 | Equinoxe® Shoulder SystemPHX · Traditional | Exactech, Inc. | 04/14/2026SE |
| K254128 | InSet Reverse Total Shoulder SystemPHX · Traditional | Shoulder Innovations, Inc. | 04/13/2026SE |
| K253674 | Blueprint Patient-Specific InstrumentationPHX · Traditional | Stryker Corporation (Tornier, S.A.S.) | 04/03/2026SE |
| K253624 | INHANCE Reverse Shoulder SystemPHX · Traditional | Depuy Ireland UC | 03/11/2026SE |
More from Depuy Ireland UC
| 510(k) | Device | Decision |
|---|---|---|
| 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 INHANCETM Reverse Glenoid Peripheral Posts cleared by the FDA?
INHANCETM Reverse Glenoid Peripheral Posts (K221467) received a 510(k) decision of Substantially Equivalent on August 31, 2022, 103 days after the submission was received.
What is the product code of K221467?
The FDA product code is PHX – Shoulder Prosthesis, Reverse Configuration, a Class II (moderate risk) device regulated under 21 CFR 888.3660.