Cleared Traditional

NEW JERSEY FEMORAL STEM (K842234) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K842234 · Endomedics, Inc. · Orthopedic device
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Jul 1984
Decision
45d
Days
Class 2
Risk

K842234 is an FDA 510(k) clearance for the NEW JERSEY FEMORAL STEM. Classified as Prosthesis, Hip, Hemi-, Femoral, Metal (product code KWL), Class II - Special Controls.

Submitted by Endomedics, Inc. (Walker, US). The FDA issued a Cleared decision on July 20, 1984 after a review of 45 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3360 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Endomedics, Inc. devices

Submission Details

510(k) Number K842234 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 1984
Decision Date July 20, 1984
Days to Decision 45 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 122d · This submission: 45d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KWL Prosthesis, Hip, Hemi-, Femoral, Metal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3360
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - KWL Prosthesis, Hip, Hemi-, Femoral, Metal

All 52
Devices cleared under the same product code (KWL) and FDA review panel - the closest regulatory comparables to K842234.
POROUS APF/COLLARLESS MODULAR FEMORAL COMPONENT
K852584 · Biomet, Inc. · Aug 1985
NORMALIZED HS3N PROPORTIONAL SERIES HIP STEMS
K844818 · Osteonics Corp. · Jul 1985
AUSTIN-MOORE MODULAR HIP PROSTHESIS
K845025 · Biomet, Inc. · Apr 1985
PENNSYLVANIA HOSPITAL HIP SYS
K841437 · Biomet, Inc. · Jun 1984
MODIFIED HPS HIP PROSTHESIS
K833599 · Depuy, Inc. · Mar 1984
AUFRANC-TURNER ATS TOTAL HIP SYSTEM
K830307 · Howmedica Corp. · Mar 1983