Cleared Traditional

K852420 - BTM TOTAL HIP SYSTEM

K852420 is an FDA 510(k) clearance for BTM TOTAL HIP SYSTEM, manufactured by Kirschner Medical Corp.. The device is a Class 2 Orthopedic device with product code KWL cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K852420 · Kirschner Medical Corp. · Orthopedic device
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Jun 1985
Decision
21d
Days
Class 2
Risk

K852420 is an FDA 510(k) clearance for the BTM TOTAL HIP SYSTEM. Classified as Prosthesis, Hip, Hemi-, Femoral, Metal (product code KWL), Class II - Special Controls.

Submitted by Kirschner Medical Corp. (Timonium, US). The FDA issued a Cleared decision on June 28, 1985 after a review of 21 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Kirschner Medical Corp. devices

FDA 510(k) Submission Details - K852420

510(k) Number K852420 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 1985
Decision Date June 28, 1985
Days to Decision 21 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
101d faster than avg
Panel avg: 122d · This submission: 21d
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 K852420.
BIO-FIT HIP SYSTEM
K854791 · Richards Medical Co., Inc. · Feb 1986
POROUS APF/COLLARLESS MODULAR FEMORAL COMPONENT
K852584 · Biomet, Inc. · Aug 1985
NORMALIZED HS3N PROPORTIONAL SERIES HIP STEMS
K844818 · Osteonics Corp. · Jul 1985
TF-II HIP PROSTHESIS
K843995 · Dow Corning Corp. Healthcare Industries Materials · Apr 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