Cleared Traditional

K843995 - TF-II HIP PROSTHESIS

K843995 is an FDA 510(k) clearance for TF-II HIP PROSTHESIS, 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 194-day FDA review.

K843995 · Dow Corning Corp. Healthcare Industries Materials · Orthopedic device
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Apr 1985
Decision
194d
Days
Class 2
Risk

K843995 is an FDA 510(k) clearance for the TF-II HIP PROSTHESIS. 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 April 23, 1985 after a review of 194 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 - K843995

510(k) Number K843995 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 1984
Decision Date April 23, 1985
Days to Decision 194 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
72d slower than avg
Panel avg: 122d · This submission: 194d
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 K843995.
POROUS APF/COLLARLESS MODULAR FEMORAL COMPONENT
K852584 · Biomet, Inc. · Aug 1985
NORMALIZED HS3N PROPORTIONAL SERIES HIP STEMS
K844818 · Osteonics Corp. · Jul 1985
BTM TOTAL HIP SYSTEM
K852420 · Kirschner Medical Corp. · Jun 1985
AUSTIN-MOORE MODULAR HIP PROSTHESIS
K845025 · Biomet, Inc. · Apr 1985
WHITESIDE ORTHOLOC TOTAL HIP FEMORAL
K842559 · Dow Corning Corp. Healthcare Industries Materials · Dec 1984
PENNSYLVANIA HOSPITAL HIP SYS
K841437 · Biomet, Inc. · Jun 1984