Cleared Special

K042636 - BIOPLUS

K042636 is an FDA 510(k) clearance for BIOPLUS, manufactured by Berkeley Advanced Biomaterials, Inc.. The device is a Class 2 Orthopedic device with product code MQV cleared through the Special 510(k) pathway after a 78-day FDA review.

K042636 · Berkeley Advanced Biomaterials, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2004
Decision
78d
Days
Class 2
Risk

K042636 is an FDA 510(k) clearance for the BIOPLUS. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Berkeley Advanced Biomaterials, Inc. (San Leandro, US). The FDA issued a Cleared decision on December 14, 2004 after a review of 78 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K042636

510(k) Number K042636 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2004
Decision Date December 14, 2004
Days to Decision 78 days
Submission Type Special
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
44d faster than avg
Panel avg: 122d · This submission: 78d
Pathway characteristics
Modification to existing cleared device.

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 492
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K042636.
BF+
K043347 · Ldr Spine USA · Jan 2005
CEMENTEK LV
K042911 · Teknimed, S.A. · Dec 2004
POLYGRAFT BGS
K040047 · Osteobiologics, Inc. · Dec 2004
KASIOS TCP
K042340 · Kasios Biomaterials · Nov 2004
OSSAPLAST ORTHO, O.5ML, MODEL# 221 900, OSSAPLAST ORTHO, 1.0ML, MODEL# 221 901, OSSAPLAST ORTHO, 3.0ML, MODEL# 221 903
K042305 · Ossacur AG · Oct 2004
ALLOMATRIX TCP, ALLOMATRIX W/CASO4 FILLED TCP, AND ALLOMATRIX PLUS CBM
K041663 · Wrightmedicaltechnologyinc · Sep 2004
K042636 · BIOPLUS
Download PDF FDA Summary Berkeley Advanced Bio…