METAL-ON-METAL HIP SYSTEMS-ADDITIONAL CONTRAINDICATIONS— 510(k) K113271

Name: FDA 510(k) clearance K113271
Creator: U.S. Food and Drug Administration
Published: 2012-05-18

Substantially Equivalent

Biomet Manufacturing, Inc.

FDA 510(k) clearance K113271 for METAL-ON-METAL HIP SYSTEMS-ADDITIONAL CONTRAINDICATIONS, Substantially Equivalent on 2012-05-18. Applicant: Biomet Manufacturing, Inc.. Device class: 3.

Clearance details

Applicant: Biomet Manufacturing, Inc.
Product code: Code KWA
Device class: Class 3
Regulation: 21 CFR 888.3330
Advisory panel: Orthopedic
Date received: 2011-11-04
Decision date: 2012-05-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warsaw, IN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KWA

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K122778 — PROFEMUR Z REVISION HIP STEM2012-10-11
K121544 — DYNASTY BIOFOAM SHELL2012-07-30
K113322 — CONSERVE THIN SHELL2012-02-03
K112080 — PRESERVE HIP STEM2011-12-28
K112150 — PROFEMUR GLADIATOR HA HIP STEM2011-11-23

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K080088 — BIOMET SPORTS MEDICINE ANCHOR DEVICES AND ZIPLOOP CONSTRUCTS2008-06-11
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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.