K080108 is an FDA 510(k) clearance for the CORTOSS BONE AUGMENTATION MATERIAL. Classified as Cement, Bone, Vertebroplasty (product code NDN), Class II - Special Controls.
Submitted by Orthovita, Inc. (Malver, US). The FDA issued a Cleared decision on June 5, 2009 after a review of 507 days - an unusually long review period, suggesting complex equivalence evaluation.
This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3027 - 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 Orthovita, Inc. devices
NCT00290862
Unknown
Interventional
Industry-sponsored
A Safety and Efficacy Study for Treatment of Painful Vertebral Compression Fractures Caused by Osteoporosis
A Randomized, Controlled Clinical Study to Evaluate the Safety and Effectiveness of CORTOSS® Synthetic Cortical Bone Void Filler in Vertebral Augmentation
| Condition studied |
Spinal Fractures |
| Study design |
Parallel |
| Eligibility |
All sexes
· 18 Years+
· Healthy volunteers accepted
|
| Principal investigator |
Maarten Persenaire, M.D. |
| Sponsor |
Orthovita d/b/a Stryker
(industry)
|
Started 2004-09-01
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Completed 2009-03-01
Primary outcome
Early and sustained decrease in pain (efficacy prong of primary endpoint) at 24 months compared to pre-treatment baseline using the Visual Analog Scale (VAS)
Secondary outcome
Maintenance or improvement in quality of life (secondary endpoint) at 24 months compared to baseline using the SF-12
View full study on ClinicalTrials.gov