Cleared Traditional

K110949 - BICERA (TM) RESORBABLE BONE SUBSTITUTE

K110949 is the FDA 510(k) clearance for BICERA (TM) RESORBABLE BONE SUBSTITUTE by Wiltrom Corporation Limited. It is a Class 2 Orthopedic device (product code MQV) cleared through the Traditional 510(k) pathway after a 533-day FDA review.

K110949 · Wiltrom Corporation Limited · Orthopedic device
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Optimized for regulatory review, auditing and printing
Sep 2012
Decision
533d
Days
Class 2
Risk

K110949 is an FDA 510(k) clearance for the BICERA (TM) RESORBABLE BONE SUBSTITUTE. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Wiltrom Corporation Limited (Chutung Township, Hsinchu, TW). The FDA issued a Cleared decision on September 18, 2012 after a review of 533 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Orthopedic submissions.

View all Wiltrom Corporation Limited devices

Submission Details

510(k) Number K110949 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 2011
Decision Date September 18, 2012
Days to Decision 533 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
411d slower than avg
Panel avg: 122d · This submission: 533d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 231
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K110949.
PRO-DENSE BONE GRAFT SUBSTITUTE
K113871 · Wrightmedicaltechnologyinc · Mar 2013
MAGNIFUSE BONE GRAFT (CLEARED AS GRAFTON II EDBM)
K123691 · Medtronic Sofamor Danek, Inc. · 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
FORTROSS BONE VOID FILLER
K110561 · Pioneer Surgical Technology · Apr 2011
NORIAN DRILLABLE INJECT, NORIAN DRILLABLE FAST SET PUTTY
K102722 · Synthes USA Products, LLC · Jan 2011
MICROFUSE PUTTY AND MICROFUSE ST MIS
K102392 · Globus Medical, Inc. · Dec 2010