Cleared Traditional

K070050 - VITALITY HIP SYSTEM MODEL#420

K070050 is the FDA 510(k) clearance for VITALITY HIP SYSTEM MODEL#420 by Encore Medical, L.P.. It is a Class 2 Orthopedic device (product code LPH) cleared through the Traditional 510(k) pathway after a 139-day FDA review.

K070050 · Encore Medical, L.P. · Orthopedic device
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May 2007
Decision
139d
Days
Class 2
Risk

K070050 is an FDA 510(k) clearance for the VITALITY HIP SYSTEM MODEL#420. 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 May 23, 2007 after a review of 139 days - within the typical 510(k) review window.

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 Encore Medical, L.P. devices

Submission Details

510(k) Number K070050 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 04, 2007
Decision Date May 23, 2007
Days to Decision 139 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
17d slower than avg
Panel avg: 122d · This submission: 139d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 428
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K070050.
FOUNDATION (FMP) POROUS COATED SPIKED ACETABULAR SYSTEM
K072154 · Encore Medical, L.P. · Dec 2007
REFLECTION, TANDEM UNIPOLAR
K071160 · Smith & Nephew, Inc. · Oct 2007
DEPUY PINNACLE WITH GRIPTON ACETABULAR CUPS
K071784 · DePuy Orthopaedics, Inc. · Jul 2007
REGENERX RINGLOC + MODULAR ACETABULAR SHELLS
K070369 · Biomet, Inc. · Mar 2007
EUROPEAN STYLE TAPER,PRESS-FIT HIP STEM
K062775 · Ortho Development Corp. · Jan 2007
MAYO CONSERVATIVE HIP PROSTHESIS, MODEL 00.65-8026-010-05
K061461 · Zimmer, Inc. · Dec 2006