Catalyst R1 Reverse Shoulder System
FDA 510(k) K223655 · Catalyst Orthoscience, Inc.
510(k) numberK223655
Submission
- Device name
- Catalyst R1 Reverse Shoulder System
- Applicant
- Catalyst Orthoscience, Inc.
Naples, FL, US - Received
- December 6, 2022
- Decision date
- May 9, 2023
- 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 |
|---|---|---|
| K252418 | Catalyst F1x Shoulder SystemKWS · Traditional | 11/06/2025SE |
| K234105 | Catalyst F1x Shoulder SystemPHX · Traditional | 04/05/2024SE |
| K232583 | Catalyst R1 Reverse Shoulder SystemPHX · Special | 09/20/2023SE |
| K222317 | Catalyst EA Convertible Stemmed ShoulderKWS · Traditional | 11/10/2022SE |
| K213349 | Catalyst R1 Reverse Shoulder SystemPHX · Traditional | 06/23/2022SE |
| K211991 | Catalyst R1 Reverse Shoulder SystemPHX · Special | 07/28/2021SE |
| K202611 | Catalyst OrthoScience R1 Reverse Shoulder SystemPHX · Traditional | 02/12/2021SE |
| K191811 | Catalyst OrthoScience CSR Shoulder SystemKWT · Special | 09/11/2019SE |
| K182500 | Catalyst CSR Press-Fit Humeral ComponentsKWT · Traditional | 01/11/2019SE |
| K181287 | Catalyst CSR Shoulder SystemKWT · Special | 07/12/2018SE |
Questions and answers
When was Catalyst R1 Reverse Shoulder System cleared by the FDA?
Catalyst R1 Reverse Shoulder System (K223655) received a 510(k) decision of Substantially Equivalent on May 9, 2023, 154 days after the submission was received.
What is the product code of K223655?
The FDA product code is PHX – Shoulder Prosthesis, Reverse Configuration, a Class II (moderate risk) device regulated under 21 CFR 888.3660.