A.L.P.S. Proximal Humerus Plating System— 510(k) K251620

Name: FDA 510(k) clearance K251620
Creator: U.S. Food and Drug Administration
Published: 2025-07-25

Substantially Equivalent

Zimmer Biomet

FDA 510(k) clearance K251620 for A.L.P.S. Proximal Humerus Plating System, Substantially Equivalent on 2025-07-25. Applicant: Zimmer Biomet. Device class: 2.

Clearance details

Applicant: Zimmer Biomet
Product code: Code HRS
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 2025-05-27
Decision date: 2025-07-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warsaw, IN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HRS

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K261830 — FRAXION 3.5 Plate System (Various - See Catalog) +3 more2026-08-28
K262537 — Versalock Sterile Plating System2026-08-19
K260277 — MIKRON TRAUMA BONE PLATE& SCREW SYSTEM2026-08-13
K261511 — Xpert Ankle2026-07-28
K261406 — Versalock Proximal Tibial Plating System2026-07-21

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K251834 — Persona Partial Knee2025-08-15
K243571 — Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained Liners2025-07-31
K250834 — Zimmer Biomet Ceramic Heads (22.2mm diameter)2025-04-18
K243293 — Zimmer® Persona® Personalized Knee System2024-12-20

Adverse events under product code HRS

product code HRS

Death: 27
Injury: 10,340
Malfunction: 3,328
Total: 13,695

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.