Cleared Traditional

K040262 - DBX DEMINERALIZED BONE MATRIX PUTTY, BONE MATRIX PASTE AND BONE MATRIX MIX

K040262 is an FDA 510(k) clearance for DBX DEMINERALIZED BONE MATRIX PUTTY, manufactured by Musculoskeletal Transplant Foundation. The device is a Class 2 Orthopedic device with product code MQV cleared through the Traditional 510(k) pathway after a 407-day FDA review.

K040262 · Musculoskeletal Transplant Foundation · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2005
Decision
407d
Days
Class 2
Risk

K040262 is an FDA 510(k) clearance for the DBX DEMINERALIZED BONE MATRIX PUTTY, BONE MATRIX PASTE AND BONE MATRIX MIX. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Musculoskeletal Transplant Foundation (Edison, US). The FDA issued a Cleared decision on March 17, 2005 after a review of 407 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Orthopedic submissions.

View all Musculoskeletal Transplant Foundation devices

FDA 510(k) Submission Details - K040262

510(k) Number K040262 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 2004
Decision Date March 17, 2005
Days to Decision 407 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
285d slower than avg
Panel avg: 122d · This submission: 407d
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 K040262.
OSMOSYS CALCIUM PHOSPHATE CERAMIC BONE FILLER
K050490 · Medicrea · Apr 2005
GENEROS, MODELS GO-01G, GO-05G, GO-10G, GO-15G, GO-20G, GO-30G, GO-40G, GO-60G, GO-XYZ SERIES, GO-DZ SERIES
K050666 · Berkeley Advanced Biomaterials, Inc. · Apr 2005
OSSAPLAST ORTHO
K050416 · Ossacur AG · Mar 2005
INTERGRO DBM
K031399 · Interpore Cross Intl. · Feb 2005
MODIFICATION TO: HEALOS BONE GRAFT MATERIAL
K043308 · Depuy Spine, Inc. · Feb 2005
OPTEFORM, OSTEOFIL, RTI ALLOGRAFT PASTE IC, RTI ALLOGRAFT STRIP IC
K043421 · Regeneration Technologies, Inc. · Feb 2005