Cleared Traditional

K842233 - NEW JERSEY FEMORAL RESURFACING COMPONENT

K842233 is an FDA 510(k) clearance for NEW JERSEY FEMORAL RESURFACING COMPONENT, manufactured by Endomedics, Inc.. The device is a Class 2 Orthopedic device with product code KXA cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K842233 · Endomedics, Inc. · Orthopedic device
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Jul 1984
Decision
45d
Days
Class 2
Risk

K842233 is an FDA 510(k) clearance for the NEW JERSEY FEMORAL RESURFACING COMPONENT. Classified as Prosthesis, Hip, Femoral, Resurfacing (product code KXA), Class II - Special Controls.

Submitted by Endomedics, Inc. (Mchenry, 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 888.3400 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K842233

510(k) Number K842233 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.

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 21
Devices cleared under the same product code (KXA) and FDA review panel - the closest regulatory comparables to K842233.
BIOPRO PROXIMAL FEMORAL ARTICULAR REPLACEMENT
K894604 · Biopro, Inc. · Nov 1989
BIPOLAR HIP SYSTEM
K892398 · Orthomet, Inc. · May 1989
LSF (R) TOTAL HIP SYSTEM - BIPOLAR COMPONENT
K883212 · Implant Technology, Inc. · Nov 1988
TILLMAN HIP RESURFACING REPLACEMT PROS.
K792200 · Waldemar Link GmbH & Co. KG · Dec 1979
TILLMAN HIPSURFACE REPLACEMENT
K781490 · Waldemar Link GmbH & Co. KG · Sep 1978
K842233 · NEW JERSEY FEMORAL RESURFACING COMPONENT
Download PDF Endomedics, Inc.