EMPOWR Dual Mobility Metal Liner, EMPOWR Dual Mobility Poly Bearing— 510(k) K203557
Substantially EquivalentEncore Medical L.P.
FDA 510(k) clearance K203557 for EMPOWR Dual Mobility Metal Liner, EMPOWR Dual Mobility Poly Bearing, Substantially Equivalent on 2021-02-10. Applicant: Encore Medical L.P.. Device class: 2.
Clearance details
- Applicant
- Encore Medical L.P.
- Product code
- Code LPH
- Device class
- Class 2
- Regulation
- 21 CFR 888.3358
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Austin, TX, US
Recent devices under product code LPH
view allMore clearances from Encore Medical L.P.
view allAdverse events under product code LPH
product code LPH- Death
- 73
- Injury
- 31,640
- Malfunction
- 3,358
- Other
- 2
- Total
- 35,073
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K203557
K-number listed on FDA's recall record- Z-2147-2025 — Brand Name: EMPOWR Dual Mobility" Product Name: EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD40 Model/Catalog Number: 952-28-40E Software Version: NA Product Description: The EMPOWR Dual Mobility" system is compatible with the EMPOWR Acetabular¿ system, 28mm femoral heads and all hip stems Component: NA
- Z-2148-2025 — Brand Name: EMPOWR Dual Mobility" Product Name: EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD42 Model/Catalog Number: 952-28-42F Software Version: NA Product Description: The EMPOWR Dual Mobility" system is compatible with the EMPOWR Acetabular¿ system, 28mm femoral heads and all hip stems Component: NA
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K203557.
Data sourced from openFDA. This site is unofficial and independent of the FDA.