Cleared Abbreviated

K082498 - GRAFTYS HBS

K082498 is an FDA 510(k) clearance for GRAFTYS HBS, manufactured by Graftys. The device is a Class 2 Orthopedic device with product code MQV cleared through the Abbreviated 510(k) pathway after a 180-day FDA review.

K082498 · Graftys · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2009
Decision
180d
Days
Class 2
Risk

K082498 is an FDA 510(k) clearance for the GRAFTYS HBS. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Graftys (Aix En Provence, FR). The FDA issued a Cleared decision on February 25, 2009 after a review of 180 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3045 - the FDA orthopedic device regulatory framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Graftys devices

FDA 510(k) Submission Details - K082498

510(k) Number K082498 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 2008
Decision Date February 25, 2009
Days to Decision 180 days
Submission Type Abbreviated
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
58d slower than avg
Panel avg: 122d · This submission: 180d
Pathway characteristics
Standards-based clearance path.

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 479
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K082498.
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