APR II NON POROUS HIP STEM— 510(k) K944209

Name: FDA 510(k) clearance K944209
Creator: U.S. Food and Drug Administration
Published: 1994-12-09

Substantially Equivalent for Some Indications

Intermedics Orthopedics

FDA 510(k) clearance K944209 for APR II NON POROUS HIP STEM, Substantially Equivalent for Some Indications on 1994-12-09. Applicant: Intermedics Orthopedics. Device class: 2.

Clearance details

Applicant: Intermedics Orthopedics
Product code: Code LZO
Device class: Class 2
Regulation: 21 CFR 888.3353
Advisory panel: Orthopedic
Date received: 1994-08-29
Decision date: 1994-12-09
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

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K260182 — Avenir® Müller Stem; Avenir Complete Hip System2026-04-27
K260037 — implantcast Packaging System Update2026-03-30

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K970166 — NATURAL-HIP SYSTEM COCR REVISION STEM1997-04-08
K970567 — SELECT SHOULDER CURVED-BACK PEGGED ALL POLY GLENOIDS1997-02-27
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Adverse events under product code LZO

product code LZO

Death: 17
Injury: 12,942
Malfunction: 1,756
Total: 14,715

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.