Cleared Traditional

K171629 - ABCcolla Bone Graft

K171629 is an FDA 510(k) clearance for ABCcolla Bone Graft, manufactured by Acro Biomedical Co., Ltd.. The device is a Class 2 Orthopedic device with product code MQV cleared through the Traditional 510(k) pathway after a 244-day FDA review.

K171629 · Acro Biomedical Co., Ltd. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Feb 2018
Decision
244d
Days
Class 2
Risk

K171629 is an FDA 510(k) clearance for the ABCcolla Bone Graft. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Acro Biomedical Co., Ltd. (Kaohsiung City, TW). The FDA issued a Cleared decision on February 1, 2018 after a review of 244 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 Acro Biomedical Co., Ltd. devices

FDA 510(k) Submission Details - K171629

510(k) Number K171629 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 2017
Decision Date February 01, 2018
Days to Decision 244 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
122d slower than avg
Panel avg: 122d · This submission: 244d
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 290
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K171629.
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
Bicera Resorbable Bone Substitute
K172237 · Wiltrom Corporation Limited · Feb 2018
BioSphere MIS Putty (BioSphere MIS)
K173301 · Synergy Biomedical, LLC · Jan 2018
NuVasive AttraX Scaffold
K172497 · Nu Vasive, Incorporated · Nov 2017
Resorbable Mesh Device
K172130 · SeaSpine Orthopedics Corporation · Nov 2017