GLADIATOR HIP STEM— 510(k) K111910

Name: FDA 510(k) clearance K111910
Creator: U.S. Food and Drug Administration
Published: 2011-10-14

Substantially Equivalent

Wrightmedicaltechnologyinc

FDA 510(k) clearance K111910 for GLADIATOR HIP STEM, Substantially Equivalent on 2011-10-14. Applicant: Wrightmedicaltechnologyinc. Device class: 3.

Clearance details

Applicant: Wrightmedicaltechnologyinc
Product code: Code KWA
Device class: Class 3
Regulation: 21 CFR 888.3330
Advisory panel: Orthopedic
Date received: 2011-07-05
Decision date: 2011-10-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Arlington, TN, 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
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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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.