Cleared Traditional

K042829 - DBX STRIP

K042829 is an FDA 510(k) clearance for DBX STRIP, manufactured by Musculoskeletal Transplant Foundation. The device is a Class 2 Orthopedic device with product code MBP cleared through the Traditional 510(k) pathway after a 458-day FDA review.

K042829 · Musculoskeletal Transplant Foundation · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2006
Decision
458d
Days
Class 2
Risk

K042829 is an FDA 510(k) clearance for the DBX STRIP. Classified as Filler, Bone Void, Osteoinduction (w/o Human Growth Factor) (product code MBP), Class II - Special Controls.

Submitted by Musculoskeletal Transplant Foundation (Edison, US). The FDA issued a Cleared decision on January 13, 2006 after a review of 458 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 - K042829

510(k) Number K042829 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 2004
Decision Date January 13, 2006
Days to Decision 458 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
336d slower than avg
Panel avg: 122d · This submission: 458d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MBP Device Classification - Class 2, Special Controls

Product Code MBP Filler, Bone Void, Osteoinduction (w/o Human Growth Factor)
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 - MBP Filler, Bone Void, Osteoinduction (w/o Human Growth Factor)

All 25
Devices cleared under the same product code (MBP) and FDA review panel - the closest regulatory comparables to K042829.
AFT ALLOGRAFT FILLER TUBE
K060161 · Musculoskeletal Transplant Foundation · Mar 2006
OPTECURE
K050806 · Exactech, Inc. · Feb 2006
OSTEOSET DBM PELLETS
K053642 · Wrightmedicaltechnologyinc · Jan 2006
GRAFTON DBM
K051195 · Osteotech, Inc. · Dec 2005
VIAGRAF DBM PASTE
K043209 · Osteotech, Inc. · Dec 2005
ORTHOBLAST II PUTTY AND PASTE
K050642 · Isotis Orthobiologics, Inc. · Dec 2005