Cleared Traditional

K091193 - ACCELL EVO3C

K091193 is an FDA 510(k) clearance for ACCELL EVO3C, manufactured by Isotis Orthobiologics, Inc.. The device is a Class 2 Orthopedic device with product code MBP cleared through the Traditional 510(k) pathway after a 109-day FDA review.

K091193 · Isotis Orthobiologics, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2009
Decision
109d
Days
Class 2
Risk

K091193 is an FDA 510(k) clearance for the ACCELL EVO3C. Classified as Filler, Bone Void, Osteoinduction (w/o Human Growth Factor) (product code MBP), Class II - Special Controls.

Submitted by Isotis Orthobiologics, Inc. (Irvine, US). The FDA issued a Cleared decision on August 10, 2009 after a review of 109 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K091193

510(k) Number K091193 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 2009
Decision Date August 10, 2009
Days to Decision 109 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
13d faster than avg
Panel avg: 122d · This submission: 109d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MBP Device Classification - Class 2, Special Controls

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.

Regulatory Peers - MBP Filler, Bone Void, Osteoinduction (w/o Human Growth Factor)

All 30
Devices cleared under the same product code (MBP) and FDA review panel - the closest regulatory comparables to K091193.
CLEARED UNDER GRAFTON II EDBM
K122513 · Medtronic Sofamor Danek, Inc. · Mar 2013
SURFUSE GEL AND PUTTY, EXFUSE GEL AND PUTTY
K113728 · Hans Biomed Corp. · Nov 2012
ACCELL EVO3 (FORMERLY ACCELL A2I)
K103742 · Integra Life Sciences · Mar 2011
DBX DEMINERALIZED BONE MATRIX PUTTY, DBX DEMINERALIZED BONE MATRIX PASTE
K080399 · Musculoskeletal Transplant Foundation · Oct 2008
ACCELL TBM-R
K081817 · Isotis Orthobiologics, Inc. · Sep 2008
SYGNAL DBM
K080405 · Musculoskeletal Transplant Foundation · Aug 2008
K091193 · ACCELL EVO3C
Download PDF FDA Summary Isotis Orthobiologics…