restor3d Reverse Total Shoulder Arthroplasty System
FDA 510(k) K243643 · Restor3D
510(k) numberK243643
Submission
- Device name
- restor3d Reverse Total Shoulder Arthroplasty System
- Applicant
- Restor3D
Durham, NC, US - Received
- November 26, 2024
- Decision date
- May 19, 2025
- 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 |
|---|---|---|
| K260556 | Veritas Shoulder SystemPHX · Traditional | 07/01/2026SE |
| K253992 | Veritas Reverse Total Shoulder SystemPHX · Traditional | 05/07/2026SE |
| K252067 | Velora Acetabular SystemLPH · Traditional | 12/05/2025SE |
| K252454 | Kinos Total Ankle SystemHSN · Special | 09/03/2025SE |
| K243768 | iTotal® Identity Cruciate Retaining 3DP Porous Knee Replacement SystemMBH · Traditional | 03/27/2025SE |
| K242356 | TIDAL Fusion Cage SystemSAI · Traditional | 03/24/2025SE |
| K242868 | Kinos Total Ankle SystemHSN · Special | 10/18/2024SE |
| K241482 | Kinos Total Ankle SystemHSN · Traditional | 07/22/2024SE |
| K240591 | restor3d Kinos Axiom Total Ankle SystemHSN · Traditional | 04/29/2024SE |
| K234087 | restor3d TIDAL Lumbar Interbody Fusion SystemMAX · Special | 01/22/2024SE |
Questions and answers
When was restor3d Reverse Total Shoulder Arthroplasty System cleared by the FDA?
restor3d Reverse Total Shoulder Arthroplasty System (K243643) received a 510(k) decision of Substantially Equivalent on May 19, 2025, 174 days after the submission was received.
What is the product code of K243643?
The FDA product code is PHX – Shoulder Prosthesis, Reverse Configuration, a Class II (moderate risk) device regulated under 21 CFR 888.3660.