Cleared Traditional

K904870 - MODIFIED NEW JERSEY FEMORAL HIP RESURFACING COMPON

K904870 is an FDA 510(k) clearance for MODIFIED NEW JERSEY FEMORAL HIP RESURFA..., manufactured by Endotec, Inc.. The device is a Class 2 Orthopedic device with product code KXA cleared through the Traditional 510(k) pathway after a 212-day FDA review.

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

FDA 510(k) Submission Details - K904870

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.

KXA Device Classification - Class 2, Special Controls

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.

Regulatory Peers - KXA Prosthesis, Hip, Femoral, Resurfacing

All 18
Devices cleared under the same product code (KXA) and FDA review panel - the closest regulatory comparables to K904870.
NELSON RESURFACING HEAD
K983452 · Biomet, Inc. · Dec 1998
MODUILAR UNIPOLAR
K950998 · Intermedics Orthopedics · Apr 1995
ORTHOMET RESURFACING FEMORAL COMPONENT
K944752 · Orthomet, Inc. · Dec 1994
BIOPRO PROXIMAL FEMORAL ARTICULAR REPLACEMENT
K894604 · Biopro, Inc. · Nov 1989
BIPOLAR HIP SYSTEM
K892398 · Orthomet, Inc. · May 1989
TILLMAN HIP RESURFACING REPLACEMT PROS.
K792200 · Waldemar Link GmbH & Co. KG · Dec 1979