Cleared Traditional

K080511 - PLEXUR-P

K080511 is an FDA 510(k) clearance for PLEXUR-P, manufactured by Osteotech, Inc.. The device is a Class 2 Orthopedic device with product code MQV cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K080511 · Osteotech, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2008
Decision
56d
Days
Class 2
Risk

K080511 is an FDA 510(k) clearance for the PLEXUR-P. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Osteotech, Inc. (Eatontown, US). The FDA issued a Cleared decision on April 21, 2008 after a review of 56 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 Osteotech, Inc. devices

FDA 510(k) Submission Details - K080511

510(k) Number K080511 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 2008
Decision Date April 21, 2008
Days to Decision 56 days
Submission Type Traditional
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
66d faster than avg
Panel avg: 122d · This submission: 56d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 406
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K080511.
GENEX PUTTY
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K081439 · Orthovita, Inc. · Jun 2008
NOVABONE PUTTY- BIOACTIVE SYNTHETIC GRAFT
K080009 · Novabone Products, LLC · May 2008
PLEXUR M
K073405 · Osteotech, Inc. · Mar 2008
PROGENIX DMB PUTTY
K072265 · Medtronic Sofamor Danek · Jan 2008
MICROFUSE BONE VOID FILLER
K071187 · Globus Medical, Inc. · Dec 2007