Cleared Traditional

POLYBONE GRANULE & BLOCK (K082338) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K082338 · Kyung Won Medical Co., Ltd. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2008
Decision
63d
Days
Class 2
Risk

K082338 is an FDA 510(k) clearance for the POLYBONE GRANULE & BLOCK. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Kyung Won Medical Co., Ltd. (Santa Fe Springs, US). The FDA issued a Cleared decision on October 16, 2008 after a review of 63 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. 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 Kyung Won Medical Co., Ltd. devices

Submission Details

510(k) Number K082338 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 2008
Decision Date October 16, 2008
Days to Decision 63 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
59d faster than avg
Panel avg: 122d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 200
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K082338.
MASTERGRAFT RESORBABLE CERAMIC GRANULES
K082918 · Medtronic Sofamor Danek · Feb 2009
MODIFICATION TO:MICROFUSE BONE VOID FILLER
K083232 · Globus Medical, Inc. · Dec 2008
PROGENIX PLUS
K082002 · Medtronic Sofamor Danek · Nov 2008
TRICOS A RESORBABLE BONE SUBSTITUTE
K081717 · Baxter Healthcare Corp · Oct 2008
MODIFICATION TO MICROFUSE BONE VOID FILLER
K082442 · Globus Medical, Inc. · Oct 2008
PROGENIX DMB PUTTY
K072265 · Medtronic Sofamor Danek · Jan 2008