Cleared Traditional

K172237 - Bicera Resorbable Bone Substitute

K172237 is an FDA 510(k) clearance for Bicera Resorbable Bone Substitute, manufactured by Wiltrom Corporation Limited. The device is a Class 2 Orthopedic device with product code MQV cleared through the Traditional 510(k) pathway after a 192-day FDA review.

K172237 · Wiltrom Corporation Limited · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2018
Decision
192d
Days
Class 2
Risk

K172237 is an FDA 510(k) clearance for the Bicera Resorbable Bone Substitute. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Wiltrom Corporation Limited (Zhubei City, TW). The FDA issued a Cleared decision on February 2, 2018 after a review of 192 days - an extended review 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: 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.

View all Wiltrom Corporation Limited devices

FDA 510(k) Submission Details - K172237

510(k) Number K172237 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 2017
Decision Date February 02, 2018
Days to Decision 192 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
70d slower than avg
Panel avg: 122d · This submission: 192d
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 398
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K172237.
FIBERGRAFT BG Matrix Bone Graft Substitute
K180080 · Prosidyan, Inc. · Apr 2018
DSM Biomedical Calcium Phosphate Cement
K173362 · Kensey Nash Corporation Dba Dsm Biomedical · Apr 2018
SurFuse Gel, SurFuse Putty, ExFuse Gel, ExFuse Putty
K171568 · Hans Biomed Corporation · Feb 2018
ABCcolla Bone Graft
K171629 · Acro Biomedical Co., Ltd. · Feb 2018
BioSphere MIS Putty (BioSphere MIS)
K173301 · Synergy Biomedical, LLC · Jan 2018
Osteo-P Bone Graft Substitute
K170165 · Molecular Matrix, Inc. · Dec 2017