Cleared Traditional

K172467 - OMNI ARC Anteverted Neck Hip Stem

K172467 is an FDA 510(k) clearance for OMNI ARC Anteverted Neck Hip Stem, manufactured by Omnilife Science. The device is a Class 2 Orthopedic device with product code LZO cleared through the Traditional 510(k) pathway after a 128-day FDA review.

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

FDA 510(k) Submission Details - K172467

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.

LZO Device Classification - Class 2, Special Controls

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 462
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
C2 femoral stem
K170473 · Lima Corporate S.P.A. · Nov 2017