Cleared Traditional

K080405 - SYGNAL DBM (FDA 510(k) Clearance)

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K080405 · Musculoskeletal Transplant Foundation · Orthopedic device
Aug 2008
Decision
196d
Days
Class 2
Risk

K080405 is an FDA 510(k) clearance for the SYGNAL DBM. 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 August 28, 2008 after a review of 196 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

Submission Details

510(k) Number K080405 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 2008
Decision Date August 28, 2008
Days to Decision 196 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
80d slower than avg
Panel avg: 116d · This submission: 196d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.