Cleared Traditional

K103742 - ACCELL EVO3 (FORMERLY ACCELL A2I) (FDA 510(k) Clearance)

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

K103742 · Integra Life Sciences · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2011
Decision
84d
Days
Class 2
Risk

K103742 is an FDA 510(k) clearance for the ACCELL EVO3 (FORMERLY ACCELL A2I). Classified as Filler, Bone Void, Osteoinduction (w/o Human Growth Factor) (product code MBP), Class II - Special Controls.

Submitted by Integra Life Sciences (Irvine, US). The FDA issued a Cleared decision on March 17, 2011 after a review of 84 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 Integra Life Sciences devices

Submission Details

510(k) Number K103742 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2010
Decision Date March 17, 2011
Days to Decision 84 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
38d faster than avg
Panel avg: 122d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MBP Filler, Bone Void, Osteoinduction (w/o Human Growth Factor)
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.