Dual Mobility - Longevity and Vivacit-E Polyethylene Hip Bearings— 510(k) K190656
Substantially EquivalentZimmer, Inc.
FDA 510(k) clearance K190656 for Dual Mobility - Longevity and Vivacit-E Polyethylene Hip Bearings, Substantially Equivalent on 2019-12-06. Applicant: Zimmer, Inc.. Device class: 2.
Clearance details
- Applicant
- Zimmer, Inc.
- Product code
- Product 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
- Warsaw, IN, US
Recent devices under product code LPH
view allMore clearances from Zimmer, Inc.
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 K190656
K-number listed on FDA's recall record- Z-0418-2026 — Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene, 28 mm I.D., 44 mm O.D., Size F, Bearing, Model/Catalog Number: 110031012; semi constrained hip prosthesis
- Z-0419-2026 — Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene, 28 mm I.D., 46 mm O.D., Size G, Bearing, Model/Catalog Number: 110031013; semi constrained hip prosthesis
- Z-0057-2021 — Dual Mobility Vivacit-E Bearing, Model Number 110031009
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K190656.
Data sourced from openFDA. This site is unofficial and independent of the FDA.