Cleared Traditional

K842559 - WHITESIDE ORTHOLOC TOTAL HIP FEMORAL

K842559 is an FDA 510(k) clearance for WHITESIDE ORTHOLOC TOTAL HIP FEMORAL, manufactured by Dow Corning Corp. Healthcare Industries Materials. The device is a Class 2 Orthopedic device with product code KWL cleared through the Traditional 510(k) pathway after a 171-day FDA review.

K842559 · Dow Corning Corp. Healthcare Industries Materials · Orthopedic device
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Dec 1984
Decision
171d
Days
Class 2
Risk

K842559 is an FDA 510(k) clearance for the WHITESIDE ORTHOLOC TOTAL HIP FEMORAL. Classified as Prosthesis, Hip, Hemi-, Femoral, Metal (product code KWL), Class II - Special Controls.

Submitted by Dow Corning Corp. Healthcare Industries Materials (P.O. Box 1767 Midland, US). The FDA issued a Cleared decision on December 20, 1984 after a review of 171 days - an extended review 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: 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 Dow Corning Corp. Healthcare Industries Materials devices

FDA 510(k) Submission Details - K842559

510(k) Number K842559 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 1984
Decision Date December 20, 1984
Days to Decision 171 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
49d slower than avg
Panel avg: 122d · This submission: 171d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWL Device Classification - Class 2, Special Controls

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 77
Devices cleared under the same product code (KWL) and FDA review panel - the closest regulatory comparables to K842559.
BTM TOTAL HIP SYSTEM
K852420 · Kirschner Medical Corp. · Jun 1985
TF-II HIP PROSTHESIS
K843995 · Dow Corning Corp. Healthcare Industries Materials · Apr 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