510(k) K190057 ยท LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
DJO Acetabular System
| Applicant | Encore Medical L.P., Austin TX, US |
| Decision | Substantially Equivalent, Jun 7, 2019 |
| Received | Jan 11, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190057
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 2, 2026 | Encore Medical, LP EMPOWR Acetabular System: Liner, 10 degree Hooded, HXe+, 36H, REF: 942-01-36H; Liner, 10 degree Hooded, HXe+, 36J, REF: 942-01-36J; Liner, 10 degree Hooded, HXe+, 40G, REF: 942-01-40G; Liner, 10 degr Open, Classified |
LPH | None listed |
| Oct 12, 2023 | Encore Medical, LP EMPOWR Acetabular System, Liner, 10 Hooded, HXe+, 40H, REF: 942-01-40H Open, Classified |
LPH | None listed |
| Oct 21, 2022 | Encore Medical, LP EMPOWR Acetabular System, Liner, 10 deg Hooded, HXe+ 40H, REF: 942-01-40H. Orthopedic implant component. Open, Classified |
LPH | None listed |
| Sep 9, 2020 | Encore Medical, LP EMPOWR Acetabular System *** EMPOWR Acetabular Cup, Cluster Hole, 54G *** Size 54G 54 mm Dia./Cluster Hole Alpha Code G Liner P2 Porous Coated REF 940-02-54G - Product Usage: are intended for treatm Open, Classified |
LPH | None listed |
| Oct 22, 2019 | Encore Medical, LP EMPOWR Acetabular System, Non-Sterile, Model Numbers
803-15-023
803-15-026
803-15-027
803-15-028
803-15-029
803-15-030
Product Usage: The EMPOWR Acetabular Impactor Balls is intended for use in joi Open, Classified |
LPH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.