Cleared Traditional

K904870 - MODIFIED NEW JERSEY FEMORAL HIP RESURFACING COMPON (FDA 510(k) Clearance)

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

K904870 · Endotec, Inc. · Orthopedic device
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May 1991
Decision
212d
Days
Class 2
Risk

K904870 is an FDA 510(k) clearance for the MODIFIED NEW JERSEY FEMORAL HIP RESURFACING COMPON. Classified as Prosthesis, Hip, Femoral, Resurfacing (product code KXA), Class II - Special Controls.

Submitted by Endotec, Inc. (South Orange, US). The FDA issued a Cleared decision on May 23, 1991 after a review of 212 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3400 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Endotec, Inc. devices

Submission Details

510(k) Number K904870 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 1990
Decision Date May 23, 1991
Days to Decision 212 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
90d slower than avg
Panel avg: 122d · This submission: 212d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KXA Prosthesis, Hip, Femoral, Resurfacing
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3400
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.