Cleared Traditional

K112857 - INTERFACE BONE VOID FILLER

K112857 is an FDA 510(k) clearance for INTERFACE BONE VOID FILLER, manufactured by Biostructures, LLC. The device is a Class 2 Orthopedic device with product code MQV cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K112857 · Biostructures, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2011
Decision
74d
Days
Class 2
Risk

K112857 is an FDA 510(k) clearance for the INTERFACE BONE VOID FILLER. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Biostructures, LLC (San Diego, US). The FDA issued a Cleared decision on December 13, 2011 after a review of 74 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 Biostructures, LLC devices

FDA 510(k) Submission Details - K112857

510(k) Number K112857 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2011
Decision Date December 13, 2011
Days to Decision 74 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
48d faster than avg
Panel avg: 122d · This submission: 74d
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 306
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K112857.
MTF NEW BONE VOID FILLER
K121313 · Musculoskeletal Transplant Foundation · Jan 2013
OPTECURE BONE VOID FILLER (0.5 CC, 1CC, 2CC, 5CC, 10CC, AND 20CC), OPTECURE + CCC BONE VOID FILLER (1CC, 2CC, 5CC, 10CC,
K121989 · Exactech, Inc. · Nov 2012
MTF NEW BONE VOILD FILLER
K113167 · Musculoskeletal Transplant Foundation · Jan 2012
NB3D BONE VOID FILLER
K111944 · Pioneer Surgical Technology, Inc. · Nov 2011
NOVABNE PUTTY BIOACTIVE SYNTHETIC BONE GRAFT
K112773 · Novabone Products, LLC · Oct 2011
MTF NEW BONE VOID FILLER
K110003 · Musculoskeletal Transplant Foundation · Oct 2011