Cleared Traditional

K833403 - BDH UNIPOLAR FEMORAL COMPONENT A2

K833403 is an FDA 510(k) clearance for BDH UNIPOLAR FEMORAL COMPONENT A2, manufactured by Carbomedics, Inc.. The device is a Class 2 Orthopedic device with product code KWL cleared through the Traditional 510(k) pathway after a 102-day FDA review.

K833403 · Carbomedics, Inc. · Orthopedic device
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Jan 1984
Decision
102d
Days
Class 2
Risk

K833403 is an FDA 510(k) clearance for the BDH UNIPOLAR FEMORAL COMPONENT A2. Classified as Prosthesis, Hip, Hemi-, Femoral, Metal (product code KWL), Class II - Special Controls.

Submitted by Carbomedics, Inc. (Walker, US). The FDA issued a Cleared decision on January 10, 1984 after a review of 102 days - within the typical 510(k) review window.

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 Carbomedics, Inc. devices

FDA 510(k) Submission Details - K833403

510(k) Number K833403 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 1983
Decision Date January 10, 1984
Days to Decision 102 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
20d faster than avg
Panel avg: 122d · This submission: 102d
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 86
Devices cleared under the same product code (KWL) and FDA review panel - the closest regulatory comparables to K833403.
WHITESIDE ORTHOLOC TOTAL HIP FEMORAL
K842559 · Dow Corning Corp. Healthcare Industries Materials · Dec 1984
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
METAL KNEE & HIP PROSTHESIS
K823051 · Zimmer, Inc. · Dec 1982
IOI 32 TM FEMORAL COMPONENT
K822321 · Intermedics Orthopedics · Aug 1982