Cleared Traditional

K180758 - Osteocera Resorbable Bone Substitute

K180758 is the FDA 510(k) clearance for Osteocera 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 216-day FDA review.

K180758 · Wiltrom Corporation Limited · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2018
Decision
216d
Days
Class 2
Risk

K180758 is an FDA 510(k) clearance for the Osteocera 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 October 24, 2018 after a review of 216 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

Submission Details

510(k) Number K180758 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 2018
Decision Date October 24, 2018
Days to Decision 216 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
94d slower than avg
Panel avg: 122d · This submission: 216d
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 230
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K180758.
FIBERGRAFT AERIDYAN Matrix Bone Graft Substitute
K182670 · Prosidyan, Inc. · Dec 2018
MagnetOs Putty
K181958 · Kuros Biosciences B.V · Dec 2018
PRODENSE Bone Graft Substitute
K182823 · Wrightmedicaltechnologyinc · Nov 2018
Ceracell Ortho Foam
K181721 · Curasan AG · Sep 2018
Sorrento Bioglass Bone Graft Substitute
K173933 · Xenco Medical, LLC · Sep 2018
BioSphere Flex
K173424 · Synergy Biomedical · Sep 2018