PARADIGM FEMORAL STEM, PERFECTA TOTAL HIP SYSTEM— 510(k) K931423

Name: FDA 510(k) clearance K931423
Creator: U.S. Food and Drug Administration
Published: 1994-10-13

Substantially Equivalent for Some Indications

Orthomed

FDA 510(k) clearance K931423 for PARADIGM FEMORAL STEM, PERFECTA TOTAL HIP SYSTEM, Substantially Equivalent for Some Indications on 1994-10-13. Applicant: Orthomed. Device class: 2.

Clearance details

Applicant: Orthomed
Product code: Code LWJ
Device class: Class 2
Regulation: 21 CFR 888.3360
Advisory panel: Orthopedic
Date received: 1993-03-22
Decision date: 1994-10-13
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Marsannay-La-Cote, FR

Download summary PDF View on FDA.gov ↗

Recent devices under product code LWJ

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K120595 — UNISYN PLUS HIP STEM2012-10-12
K103518 — TRINITY ACETABULAR SYSTEM2011-03-09
K090764 — NOVATION CFS PRESS-FIT AND CEMENTED STEMS2009-04-21
K082146 — METHA SHORT STEM HIP SYSTEM XL FEMORAL HEAD2008-09-09
K070061 — 36MM COCR FEMORAL HEAD AND 36MM ACETABULAR INSERT2007-01-31

Adverse events under product code LWJ

product code LWJ

Injury: 544
Total: 544

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.