FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Catalyst R1 Reverse Shoulder System
K Number: K223655
·
Decision May 9, 2023
Classifications
1
FEI Numbers
191
Registration Numbers
191
Same Product Code
203
Applicant Total
12
Review Days
154
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Basic Information
- Device Name
- Catalyst R1 Reverse Shoulder System
- K Number
- K223655
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3660
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Catalyst Orthoscience, Inc.
- Date Received
- December 6, 2022
- Decision Date
- May 9, 2023
- Product Code
- PHX
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| PHX | Shoulder Prosthesis, Reverse Configuration | FDA class 2 | Orthopedic |
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Other Clearances by Catalyst Orthoscience, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K252418 | Catalyst F1x Shoulder System | Nov 6, 2025 | Substantially Equivalent |
| K234105 | Catalyst F1x Shoulder System | Apr 5, 2024 | Substantially Equivalent |
| K232583 | Catalyst R1 Reverse Shoulder System | Sep 20, 2023 | Substantially Equivalent |
| K222317 | Catalyst EA Convertible Stemmed Shoulder | Nov 10, 2022 | Substantially Equivalent |
| K213349 | Catalyst R1 Reverse Shoulder System | Jun 23, 2022 | Substantially Equivalent |
| K211991 | Catalyst R1 Reverse Shoulder System | Jul 28, 2021 | Substantially Equivalent |
| K202611 | Catalyst OrthoScience R1 Reverse Shoulder System | Feb 12, 2021 | Substantially Equivalent |
| K191811 | Catalyst OrthoScience CSR Shoulder System | Sep 11, 2019 | Substantially Equivalent |
| K182500 | Catalyst CSR Press-Fit Humeral Components | Jan 11, 2019 | Substantially Equivalent |
| K181287 | Catalyst CSR Shoulder System | Jul 12, 2018 | Substantially Equivalent |