Cleared Traditional

K052735 - ALLOCRAFT DBM

K052735 is an FDA 510(k) clearance for ALLOCRAFT DBM, manufactured by Lifecell Corp.. The device is a Class 2 Orthopedic device with product code MBP cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K052735 · Lifecell Corp. · Orthopedic device
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Dec 2005
Decision
89d
Days
Class 2
Risk

K052735 is an FDA 510(k) clearance for the ALLOCRAFT DBM. Classified as Filler, Bone Void, Osteoinduction (w/o Human Growth Factor) (product code MBP), Class II - Special Controls.

Submitted by Lifecell Corp. (Washington, US). The FDA issued a Cleared decision on December 28, 2005 after a review of 89 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.

View all Lifecell Corp. devices

FDA 510(k) Submission Details - K052735

510(k) Number K052735 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2005
Decision Date December 28, 2005
Days to Decision 89 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 122d · This submission: 89d
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 20
Devices cleared under the same product code (MBP) and FDA review panel - the closest regulatory comparables to K052735.
OPTECURE
K050806 · Exactech, Inc. · Feb 2006
OSTEOSET DBM PELLETS
K053642 · Wrightmedicaltechnologyinc · Jan 2006
DBX STRIP
K042829 · Musculoskeletal Transplant Foundation · Jan 2006
GRAFTON DBM
K051195 · Osteotech, Inc. · Dec 2005
VIAGRAF DBM PASTE
K043209 · Osteotech, Inc. · Dec 2005
GRAFTON PLUS DBM PASTE
K043048 · Osteotech, Inc. · Nov 2005