Cleared Traditional

K040191 - BICONTACT HIP STEM AND FEMORAL HEAD

K040191 is an FDA 510(k) clearance for BICONTACT HIP STEM AND FEMORAL HEAD, manufactured by Aesculap. The device is a Class 2 Orthopedic device with product code LPH cleared through the Traditional 510(k) pathway after a 210-day FDA review.

K040191 · Aesculap · Orthopedic device
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Optimized for regulatory review, auditing and printing
Aug 2004
Decision
210d
Days
Class 2
Risk

K040191 is an FDA 510(k) clearance for the BICONTACT HIP STEM AND FEMORAL HEAD. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by Aesculap (Center Valley, US). The FDA issued a Cleared decision on August 25, 2004 after a review of 210 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3358 - 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 Aesculap devices

FDA 510(k) Submission Details - K040191

510(k) Number K040191 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 28, 2004
Decision Date August 25, 2004
Days to Decision 210 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
88d slower than avg
Panel avg: 122d · This submission: 210d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LPH Device Classification - Class 2, Special Controls

Product Code LPH Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3358
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 - LPH Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented

All 491
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K040191.
ZIMMER M/L TAPER HIP PROSTHESIS WITH CALCICOAT CERAMIC COATING
K042337 · Zimmer, Inc. · Nov 2004
VERSYS HIP SYSTEM BEADED MIDCOAT LOW HEAD CENTER HIP PROSTHESIS, MODEL 00-7840-XXX-XX
K042776 · Zimmer, Inc. · Nov 2004
EXACTECH 12/14 TOTAL HIP SYSTEM
K041906 · Exactech, Inc. · Sep 2004
ZIMMER ANATOMIC II HIP PROSTHESIS
K041109 · Zimmer, Inc. · Jul 2004
DURALOC OPTION ACETABULAR CUP SYSTEM, MODELS 1599-01-044 TO -066, 1599-11-044 TO -062 AND 1599-21-044 TO -062
K040544 · Depuy, Inc. · May 2004
TRIDENT T ACETABULAR SHELLS
K040412 · Stryker Orthopaedics · May 2004