Cleared Traditional

PoreStar Patient Specific Implant (K171037) - FDA 510(k) Clearance

Class II Ear, Nose, Throat device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K171037 · Anatomics Pty, Ltd. · Ear, Nose, Throat device
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Dec 2017
Decision
265d
Days
Class 2
Risk

K171037 is an FDA 510(k) clearance for the PoreStar Patient Specific Implant. Classified as Polymer, Ent Synthetic, Porous Polyethylene (product code JOF), Class II - Special Controls.

Submitted by Anatomics Pty, Ltd. (St Kilda, AU). The FDA issued a Cleared decision on December 27, 2017 after a review of 265 days - an extended review cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.3620 - the FDA ear, nose and throat device 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 Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

View all Anatomics Pty, Ltd. devices

Submission Details

510(k) Number K171037 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 2017
Decision Date December 27, 2017
Days to Decision 265 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
176d slower than avg
Panel avg: 89d · This submission: 265d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JOF Polymer, Ent Synthetic, Porous Polyethylene
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.3620
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 Ear, Nose, Throat devices follow this clearance model.