Cleared Traditional

K051695 - MARROW PLUS (M+)

K051695 is an FDA 510(k) clearance for MARROW PLUS (M+), manufactured by Berkeley Advanced Biomaterials, Inc.. The device is a Class 2 Orthopedic device with product code MQV cleared through the Traditional 510(k) pathway after a 26-day FDA review.

K051695 · Berkeley Advanced Biomaterials, Inc. · Orthopedic device
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Jul 2005
Decision
26d
Days
Class 2
Risk

K051695 is an FDA 510(k) clearance for the MARROW PLUS (M+). Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Berkeley Advanced Biomaterials, Inc. (Berkeley, US). The FDA issued a Cleared decision on July 19, 2005 after a review of 26 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K051695

510(k) Number K051695 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 2005
Decision Date July 19, 2005
Days to Decision 26 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
96d faster than avg
Panel avg: 122d · This submission: 26d
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 492
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K051695.
STERLING CANCELLOUS CHIPS
K051615 · Regeneration Technologies, Inc. · Aug 2005
OSTEOCURE RESORBABLE BEAD KIT
K051406 · Nexa Orthopedics, Inc. · Aug 2005
AFT
K042125 · Musculoskeletal Transplant Foundation · Jul 2005
CONNEXUS
K050690 · Isotis Orthobiologics, Inc. · Jul 2005
SYNTHACER
K041177 · Medartis Medizinprodukte Und Forschung AG · Jun 2005
CALLOS IMPACT AND INJECT BONE VOID FILLER
K051123 · Skeletal Kinetics, LLC · Jun 2005
K051695 · MARROW PLUS (M+)
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