510(k) K051075 ยท PHX Shoulder Prosthesis, Reverse Configuration
ENCORE REVERSE SHOULDER PROSTHESIS
| Applicant | Encore Medical L.P., Austin TX, US |
| Decision | Substantially Equivalent, May 27, 2005 |
| Received | Apr 27, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K051075
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 24, 2026 | Encore Medical, LP Brand Name: Reverse Shoulder Prosthesis (RSP)
Product Name: RSP STANDARD HUMERAL SOCKET INSERT, 36MM, HXe-plus
Model/Catalog Number: 509-00-036 Open, Classified |
PHX | None listed |
| Jan 2, 2024 | Encore Medical, LP Reverse Shoulder System e+, REF 509-01-032, RSP Humeral Socket Insert, Sz. 32mm, Semi-Constrained, Sterile H2o2, CE 2797 Completed |
PHX | None listed |
| Nov 8, 2023 | Encore Medical, LP RSP Humeral Socket Insert Size 36mm Semi-Constrained +4 mm, REF: 509-01-436, orthopedic shoulder implant component. Open, Classified |
PHX | None listed |
| Sep 19, 2023 | Encore Medical, LP DJO Surgical: Reverse Shoulder System (RSP) Semi Humeral Socket Insert, 32mm, REF: 508-01-032;
Baseplate, Glenoid HA-Coat, RSP, 6.5mm X 30mm, REF: 508-32-104;
Reverse Shoulder System (RSP) Glenoid, Ne Open, Classified |
PHX | None listed |
| Jul 6, 2011 | Encore Medical, Lp Reverse Shoulder Prosthesis System RSP Humeral Socket Shell DJO 9800 Metric Blvd. Austin, TX 78758 STERILE R Model numbers: 508-00-000 and 508-00-008.
The Reverse Shoulder Prosthesis (RSP) is indic Terminated |
KWS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.