Cleared Special

TAPERFILL FEMORAL HIP STEM 425-31-005_017 425-41-005_019 (K130099) - FDA 510(k) Clearance

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

K130099 · Encore Medical, L.P. · Orthopedic device
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Jun 2013
Decision
157d
Days
Class 2
Risk

K130099 is an FDA 510(k) clearance for the TAPERFILL FEMORAL HIP STEM 425-31-005_017 425-41-005_019. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by Encore Medical, L.P. (Austin, US). The FDA issued a Cleared decision on June 21, 2013 after a review of 157 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. 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Encore Medical, L.P. devices

Submission Details

510(k) Number K130099 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 15, 2013
Decision Date June 21, 2013
Days to Decision 157 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
35d slower than avg
Panel avg: 122d · This submission: 157d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 325
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K130099.
G7 OSSEOTI ACETUBLAR SHELLS
K140669 · Biomet, Inc. · Dec 2014
ALTEON 6.5MM BONE SCREWS
K141797 · Exactech, Inc. · Jul 2014
DEPUY PINNACLE ALTRX ACETABULAR LINERS
K132959 · DePuy Orthopaedics, Inc. · Mar 2014
ARCOS TROCHANTER BUTTON
K130063 · Biomet, Inc. · Apr 2013
SMITH & NEPHEW SMF HIP STEM
K123012 · Smith & Nephew, Inc. · Oct 2012
LONGEVITY IT HIGHLY CROSSLINKED POLYETHYENE LINERS
K123019 · Zimmer, Inc. · Oct 2012