ENCORE REVERSE SHOULDER PROSTHESIS
FDA 510(k) clearance K051075 · decided 2005-05-27
Clearance details
- K-number
- K051075
- Device name
- ENCORE REVERSE SHOULDER PROSTHESIS
- Applicant
- Encore Medical L.P.
- Decision
- Substantially Equivalent
- Date received
- 2005-04-27
- Decision date
- 2005-05-27
- Days to decision
- 30 days
- Clearance type
- Special
- Product code
- PHX
- Device class
- 2
- Regulation number
- 888.3660
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Austin, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP STANDARD HUMERAL SOCKET IN recall (Z-1460-2026) | Encore Medical, LP | 2026-02-24 |
| Reverse Shoulder System e+, REF 509-01-032, RSP Humeral Socket Insert, Sz. 32mm, Semi-Cons recall (Z-0625-2024) | Encore Medical, LP | 2024-01-02 |
| RSP Humeral Socket Insert Size 36mm Semi-Constrained +4 mm, REF: 509-01-436, orthopedic sh recall (Z-0282-2024) | Encore Medical, LP | 2023-11-08 |
| DJO Surgical: Reverse Shoulder System (RSP) Semi Humeral Socket Insert, 32mm, REF: 508-01- recall (Z-2606-2023) | Encore Medical, LP | 2023-09-19 |
| Reverse Shoulder Prosthesis System RSP Humeral Socket Shell DJO 9800 Metric Blvd. Austin, recall (Z-2739-2011) | Encore Medical, Lp | 2011-07-06 |