DEPUY PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS— 510(k) K083642

Name: FDA 510(k) clearance K083642
Creator: U.S. Food and Drug Administration
Published: 2009-03-06

Substantially Equivalent

DePuy Orthopaedics, Inc.

FDA 510(k) clearance K083642 for DEPUY PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS, Substantially Equivalent on 2009-03-06. Applicant: DePuy Orthopaedics, Inc.. Device class: 3.

Clearance details

Applicant: DePuy Orthopaedics, Inc.
Product code: Code KWA
Device class: Class 3
Regulation: 21 CFR 888.3330
Advisory panel: Orthopedic
Date received: 2008-12-09
Decision date: 2009-03-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warsaw, IN, US

Download summary PDF View on FDA.gov ↗

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K113271 — METAL-ON-METAL HIP SYSTEMS-ADDITIONAL CONTRAINDICATIONS2012-05-18
K113322 — CONSERVE THIN SHELL2012-02-03
K112080 — PRESERVE HIP STEM2011-12-28

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K210167 — DELTA XTEND Reverse Shoulder System2021-02-19
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Adverse events under product code KWA

product code KWA

Death: 38
Injury: 10,439
Malfunction: 1,862
Total: 12,339

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.