Cleared Traditional

K833404 - BDH BIPOLAR FEMORAL COMPONENT A3

K833404 is an FDA 510(k) clearance for BDH BIPOLAR FEMORAL COMPONENT A3, manufactured by Carbomedics, Inc.. The device is a Class 2 Orthopedic device with product code KWY cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K833404 · Carbomedics, Inc. · Orthopedic device
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Mar 1984
Decision
154d
Days
Class 2
Risk

K833404 is an FDA 510(k) clearance for the BDH BIPOLAR FEMORAL COMPONENT A3. Classified as Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented (product code KWY), Class II - Special Controls.

Submitted by Carbomedics, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 2, 1984 after a review of 154 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3390 - 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 Carbomedics, Inc. devices

FDA 510(k) Submission Details - K833404

510(k) Number K833404 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 1983
Decision Date March 02, 1984
Days to Decision 154 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
32d slower than avg
Panel avg: 122d · This submission: 154d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWY Device Classification - Class 2, Special Controls

Product Code KWY Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3390
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 - KWY Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented

All 81
Devices cleared under the same product code (KWY) and FDA review panel - the closest regulatory comparables to K833404.
HOWMEDICA BIPOLAR PROSTHESIS
K855231 · Howmedica Corp. · Feb 1986
KIRSCHNER BIPOLAR ENDOPROSTHETIC HEAD
K853795 · Kirschner Medical Corp. · Nov 1985
HASTINGS BIPOLAR ENDOPROSTHESIS
K842344 · Johnson & Johnson Professionals, Inc. · Sep 1984
BIOMET BIPOLAR PROSTHESIS
K833175 · Biomet, Inc. · Dec 1983
SPECTRON CONVERSION ENDOPROSTHESIS CUP
K823726 · Richard'S Medical Equip., Inc. · Mar 1983
101 UNIVERSAL ENDOPROSTHESIS
K823482 · Intermedics Orthopedics · Feb 1983