Cleared Traditional

K152958 - INEX Absorbable Nasal Implant

K152958 is an FDA 510(k) clearance for INEX Absorbable Nasal Implant, manufactured by Spirox, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code NHB cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K152958 · Spirox, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2015
Decision
58d
Days
Class 2
Risk

K152958 is an FDA 510(k) clearance for the INEX Absorbable Nasal Implant. Classified as Polymer, Ear, Nose And Throat, Synthetic, Absorbable (product code NHB), Class II - Special Controls.

Submitted by Spirox, Inc. (Menlo Park, US). The FDA issued a Cleared decision on December 4, 2015 after a review of 58 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Spirox, Inc. devices

FDA 510(k) Submission Details - K152958

510(k) Number K152958 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 07, 2015
Decision Date December 04, 2015
Days to Decision 58 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 90d · This submission: 58d
Pathway characteristics
Predicate-based equivalence.

NHB Device Classification - Class 2, Special Controls

Product Code NHB Polymer, Ear, Nose And Throat, Synthetic, Absorbable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.3620
Definition Ear, Nose, And Throat Absorbable Synthetic Polymer Material Is A Device Material That Is Intended To Be Implanted For Use As A Space-occupying Substance In The Reconstructive Surgery Of The Head And Neck. The Device Is Shaped And Formed By The Surgeon To Conform To The Patient's Needs. This Generic Type Of Device Is Made Of Absorbable Synthetic Polymer Materials.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Ear, Nose, Throat devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT02188589 Completed Interventional Industry-sponsored

Evaluation of an Absorbable Implant for the Treatment of Nasal Valve Collapse

30
Patients (actual)
1
Site
Treatment
Purpose
Open label
Masking
Condition studied Nasal Valve Collapse
Study design Single group
Eligibility All sexes · 18 Years+
Principal investigator Alexander Berghaus, MD
Sponsor Spirox, Inc. (industry)
Started 2014-04-01 → Primary completion 2015-12-01 → Completed 2017-06-01
Primary outcome
Implant-related Adverse Events
Secondary outcome
Breathing Capacity (NOSE Scores)
View full study on ClinicalTrials.gov

Regulatory Peers - NHB Polymer, Ear, Nose And Throat, Synthetic, Absorbable

All 15
Devices cleared under the same product code (NHB) and FDA review panel - the closest regulatory comparables to K152958.
LATERA Absorbable Nasal Implant System
K192661 · Entellus Medical, Inc. (Aka Stryker Ent) · Nov 2019
PuraSinus
K183015 · 3-D Matrix, Inc. · Apr 2019
Latera Absorbable Nasal Implant
K161191 · Spirox, Inc. · Jun 2016
SPIROX INEX DEVICE
K132920 · Spirox, Inc. · Jun 2014
MEROGEL INJECTABLE BIORESORBABLE NASAL DRESSING AND SINUS STENT AND OTOLOGIC GEL
K122434 · Medtronic Xomed · Oct 2012
PDS PLATES
K092590 · Ethicon, Inc. · Feb 2010