PERIARTICULAR LOCKING PLATES AND SCREWS, 2357 AND 2359 SERIES— 510(k) K042598

Name: FDA 510(k) clearance K042598
Creator: U.S. Food and Drug Administration
Published: 2004-10-29

Substantially Equivalent

Zimmer, Inc.

FDA 510(k) clearance K042598 for PERIARTICULAR LOCKING PLATES AND SCREWS, 2357 AND 2359 SERIES, Substantially Equivalent on 2004-10-29. Applicant: Zimmer, Inc.. Device class: 2.

Clearance details

Applicant: Zimmer, Inc.
Product code: Product code HRS
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 2004-09-23
Decision date: 2004-10-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warsaw, IN, US

Download summary PDF View on FDA.gov ↗

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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 →

Recalls naming K042598

K-number listed on FDA's recall record

Z-0646-2016 — Zimmer Periarticular Locking Plate System 3.5mm Locking Screw 58 mm Length; Zimmer Periarticular Locking Plate System 2.4mm Locking Screw 14 mm Length. Indicated for temporary internal fixation and stabilization of osteotomies and fractures.Class II·Terminated·Zimmer Biomet, Inc.·20151209

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K042598.

Data sourced from openFDA. This site is unofficial and independent of the FDA.