K130089 is an FDA 510(k) clearance for the CROSSTREES PVA POD. Classified as Cement, Bone, Vertebroplasty (product code NDN), Class II - Special Controls.
Submitted by Crosstrees Medical, Inc. (Philadelphia, US). The FDA issued a Cleared decision on August 9, 2013 after a review of 207 days - an extended review cycle.
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: 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.
NCT00933036
Completed
Interventional
Industry-sponsored
Clinical Evaluation of the Crosstrees Pod™ in the Treatment of Pathologic Fracture of the Vertebral Body (Levels T4 - L5) in Adult Patients
Clinical Evaluation of the Crosstrees® System for PVA in Symptomatic Adult Patients With Acute Vertebral Body Compression Fractures at T4-L5
| Condition studied |
Pathologic Fracture of the Vertebra Due to Osteoporosis |
| Study design |
Single group |
| Eligibility |
All sexes
· 50 Years+
|
| Principal investigator |
Frank M Phillips, MD |
| Sponsor |
Crosstrees Medical Inc.
(industry)
|
Started 2009-06-01
→
Primary completion 2013-06-01
Primary outcome
Clinically significant improvement in pain as measured using a 10 mm Visual Analog Scale (VAS). In this scale 0 means "no pain" and 10 is "Severe pain". A difference of at least 2 points compared to baseline is regarded as clinically relevant.
Secondary outcome
Ambulatory Status/Physical Function
Study completed - no results published.
This trial concluded in 2013 but has not posted
results to ClinicalTrials.gov. Completed studies without public results are common
in industry-sponsored device trials; the data may be referenced in the
510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov