Cleared Abbreviated

K050416 - OSSAPLAST ORTHO

K050416 is an FDA 510(k) clearance for OSSAPLAST ORTHO, manufactured by Ossacur AG. The device is a Class 2 Orthopedic device with product code MQV cleared through the Abbreviated 510(k) pathway after a 39-day FDA review.

K050416 · Ossacur AG · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2005
Decision
39d
Days
Class 2
Risk

K050416 is an FDA 510(k) clearance for the OSSAPLAST ORTHO. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Ossacur AG (Santa Barbara, US). The FDA issued a Cleared decision on March 29, 2005 after a review of 39 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 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 Ossacur AG devices

FDA 510(k) Submission Details - K050416

510(k) Number K050416 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 2005
Decision Date March 29, 2005
Days to Decision 39 days
Submission Type Abbreviated
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
83d faster than avg
Panel avg: 122d · This submission: 39d
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 326
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K050416.
NOVABONE-BIOACTIVE SYNTHETIC GRAFT
K052494 · Novabone Products, LLC · Nov 2005
OSTEOCURE RESORBABLE BEAD KIT
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AFT
K042125 · Musculoskeletal Transplant Foundation · Jul 2005
DBX DEMINERALIZED BONE MATRIX PUTTY, BONE MATRIX PASTE AND BONE MATRIX MIX
K040262 · Musculoskeletal Transplant Foundation · Mar 2005
INTERGRO DBM
K031399 · Interpore Cross Intl. · Feb 2005
MODIFICATION TO: HEALOS BONE GRAFT MATERIAL
K043308 · Depuy Spine, Inc. · Feb 2005