Cleared Traditional

K013490 - CEMENTED CALCAR HIP SYSTEM

K013490 is an FDA 510(k) clearance for CEMENTED CALCAR HIP SYSTEM, manufactured by Encore Orthopedics, Inc.. The device is a Class 2 Orthopedic device with product code LPH cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K013490 · Encore Orthopedics, Inc. · Orthopedic device
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Jan 2002
Decision
87d
Days
Class 2
Risk

K013490 is an FDA 510(k) clearance for the CEMENTED CALCAR HIP SYSTEM. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by Encore Orthopedics, Inc. (Austin, US). The FDA issued a Cleared decision on January 17, 2002 after a review of 87 days - a notably fast clearance 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: 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 Encore Orthopedics, Inc. devices

FDA 510(k) Submission Details - K013490

510(k) Number K013490 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 2001
Decision Date January 17, 2002
Days to Decision 87 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 122d · This submission: 87d
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 446
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K013490.
VAPORIZED HYDROGEN PEROXIDE (VHP) STERILIZATION OF UHMWPE COMPONENTS IN THE REFLECTION ACTABULAR SYSTEM (ACETABULAR LINE
K012787 · Smith & Nephew, Inc. · Mar 2002
TRIDENT ELEVATED RIM LINER
K020497 · Howmedica Osteonics Corp. · Mar 2002
KEYSTONE HIP SYSTEM CALCAR REPLACEMENT BODY AND BUILD UP
K020170 · Encore Orthopedics, Inc. · Feb 2002
TRIDENT POROUS TITANIUM ACETABULAR COMPONENT WITH PERI-APATITE COATING
K013475 · Howmedica Osteonics Corp. · Dec 2001
MODIFICATION TO REFLECTION CROSS-LINKED UHMWPE ACETABULAR COMPONENTS
K013658 · Smith & Nephew, Inc. · Dec 2001
CONVERGE ACETABULAR SYSTEM
K012739 · Sulzer Orthopedics, Inc. · Nov 2001