Cleared Special

K090177 - INION BIORESTORE BIODEGRADABLE BONE GRAFT SUBSTITUTE

K090177 is an FDA 510(k) clearance for INION BIORESTORE BIODEGRADABLE BONE GRA..., manufactured by Inion OY. The device is a Class 2 Orthopedic device with product code MQV cleared through the Special 510(k) pathway after a 28-day FDA review.

K090177 · Inion OY · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2009
Decision
28d
Days
Class 2
Risk

K090177 is an FDA 510(k) clearance for the INION BIORESTORE BIODEGRADABLE BONE GRAFT SUBSTITUTE. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Inion OY (Tampere, FI). The FDA issued a Cleared decision on February 20, 2009 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3045 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Inion OY devices

FDA 510(k) Submission Details - K090177

510(k) Number K090177 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 2009
Decision Date February 20, 2009
Days to Decision 28 days
Submission Type Special
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
94d faster than avg
Panel avg: 122d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

MQV Device Classification - Class 2, Special Controls

Product Code MQV Filler, Bone Void, Calcium Compound
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3045
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 - MQV Filler, Bone Void, Calcium Compound

All 467
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K090177.
INTERGRO DBM
K082793 · Biomet Spine · Apr 2009
EQUIVABONE
K090310 · Etex Corp. · Mar 2009
GRAFTYS HBS
K082498 · Graftys · Feb 2009
GAMMA-BSM, BETA-BSM
K090242 · Etex Corp. · Feb 2009
MASTERGRAFT RESORBABLE CERAMIC GRANULES
K082918 · Medtronic Sofamor Danek · Feb 2009
CALTRIX RESORBABLE BONE VOID FILLER
K083279 · Ag Digital Technology Corp. · Jan 2009