Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained Liners— 510(k) K243571
Substantially EquivalentZimmer Biomet
FDA 510(k) clearance K243571 for Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained Liners, Substantially Equivalent on 2025-07-31. Applicant: Zimmer Biomet. Device class: 2.
Clearance details
- Applicant
- Zimmer Biomet
- Product code
- Code JDI
- Device class
- Class 2
- Regulation
- 21 CFR 888.3350
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Warsaw, IN, US
Recent devices under product code JDI
view all- K253515 — Zimmer Biomet OSS Orthopedic Salvage System OsseoTi® Sleeves and Augments
- K253434 — OSSTM Orthopedic Salvage System
- K240783 — Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip Stems
- K241716 — Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee Component
- K240418 — Stryker Orthopaedics Hip Systems Labeling Update
More clearances from Zimmer Biomet
view allAdverse events under product code JDI
product code JDI- Death
- 65
- Injury
- 12,943
- Malfunction
- 1,681
- Total
- 14,689
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.