Cleared Special

BICONTACT HIP SYSTEM WITH U-CAP (K043079) - FDA 510(k) Clearance

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K043079 · Aesculap · Orthopedic device
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Dec 2004
Decision
30d
Days
Class 2
Risk

K043079 is an FDA 510(k) clearance for the BICONTACT HIP SYSTEM WITH U-CAP. Classified as Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate (product code MEH), Class II - Special Controls.

Submitted by Aesculap (Center Valley, US). The FDA issued a Cleared decision on December 8, 2004 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3353 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Aesculap devices

Submission Details

510(k) Number K043079 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 2004
Decision Date December 08, 2004
Days to Decision 30 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 122d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code MEH Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3353
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 - MEH Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate

All 103
Devices cleared under the same product code (MEH) and FDA review panel - the closest regulatory comparables to K043079.
RESTORATION ADM SYSTEM
K072020 · Howmedica Osteonics Corp. · Oct 2007
EXCIA TOTAL HIP SYSTEM WITH U-CAP
K060437 · Aesculap, Inc. · Mar 2006
SMITH & NEPHEW MODULAR HIP
K052426 · Smith & Nephew, Inc. · Dec 2005
SMITH & NEPHEW MODULAR HIP
K042127 · Smith & Nephew, Inc. · Nov 2004
CONTOUR HA COATED RECONSTRUCTION RING
K040680 · Smith & Nephew, Inc. · Jun 2004
EXACTECH ACUMATCH A-SERIES AND MCS ACETABULAR SHELLS AND LINERS
K040613 · Exactech, Inc. · Jun 2004