Cleared Traditional

OMNI ARC Anteverted Neck Hip Stem (K172467) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K172467 · Omnilife Science · Orthopedic device
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Dec 2017
Decision
128d
Days
Class 2
Risk

K172467 is an FDA 510(k) clearance for the OMNI ARC Anteverted Neck Hip Stem. Classified as Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (product code LZO), Class II - Special Controls.

Submitted by Omnilife Science (Raynham, US). The FDA issued a Cleared decision on December 21, 2017 after a review of 128 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3353 - 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 Omnilife Science devices

Submission Details

510(k) Number K172467 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 2017
Decision Date December 21, 2017
Days to Decision 128 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
6d slower than avg
Panel avg: 122d · This submission: 128d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LZO Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
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 - LZO Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented

All 309
Devices cleared under the same product code (LZO) and FDA review panel - the closest regulatory comparables to K172467.
Summit Hip System
K170339 · DePuy Orthopaedics, Inc. · Apr 2018
CoreHip® System
K172235 · Aesculap Implants Systems, LLC · Mar 2018
AMIStem-H Proximal Coating, AMIStem-P and AMIStem-P Collared
K173794 · Medacta International S.A. · Mar 2018
MasterLoc Stem: Lateralized Plus
K173267 · Medacta International S.A. · Dec 2017
M-Vizion Femoral Revision System
K170690 · Medacta International S.A. · Nov 2017
MiniMAX
K170845 · Medacta International S.A. · Aug 2017