Cleared Traditional

K113728 - SURFUSE GEL AND PUTTY, EXFUSE GEL AND PUTTY

K113728 is an FDA 510(k) clearance for SURFUSE GEL AND PUTTY, manufactured by Hans Biomed Corp.. The device is a Class 2 Orthopedic device with product code MBP cleared through the Traditional 510(k) pathway after a 332-day FDA review.

K113728 · Hans Biomed Corp. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2012
Decision
332d
Days
Class 2
Risk

K113728 is an FDA 510(k) clearance for the SURFUSE GEL AND PUTTY, EXFUSE GEL AND PUTTY. Classified as Filler, Bone Void, Osteoinduction (w/o Human Growth Factor) (product code MBP), Class II - Special Controls.

Submitted by Hans Biomed Corp. (Chevy Chase, US). The FDA issued a Cleared decision on November 15, 2012 after a review of 332 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 - K113728

510(k) Number K113728 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 2011
Decision Date November 15, 2012
Days to Decision 332 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
210d slower than avg
Panel avg: 122d · This submission: 332d
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 K113728.
VIVORTE BVF
K130703 · Vivorte, Inc. · Sep 2013
OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTY
K130498 · Bacterin International, Inc. · May 2013
CLEARED UNDER GRAFTON II EDBM
K122513 · Medtronic Sofamor Danek, Inc. · Mar 2013
ACCELL EVO3 (FORMERLY ACCELL A2I)
K103742 · Integra Life Sciences · Mar 2011
ACCELL EVO3C
K091193 · Isotis Orthobiologics, Inc. · Aug 2009
DBX DEMINERALIZED BONE MATRIX PUTTY, DBX DEMINERALIZED BONE MATRIX PASTE
K080399 · Musculoskeletal Transplant Foundation · Oct 2008