Cleared Special

K133372 - CROSSTREES PVA POD

K133372 is an FDA 510(k) clearance for CROSSTREES PVA POD, manufactured by Crosstrees Medical, Inc.. The device is a Class 2 Orthopedic device with product code NDN cleared through the Special 510(k) pathway after a 35-day FDA review.

K133372 · Crosstrees Medical, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2013
Decision
35d
Days
Class 2
Risk

K133372 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 December 6, 2013 after a review of 35 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3027 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K133372

510(k) Number K133372 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 2013
Decision Date December 06, 2013
Days to Decision 35 days
Submission Type Special
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
87d faster than avg
Panel avg: 122d · This submission: 35d
Pathway characteristics
Modification to existing cleared device.

NDN Device Classification - Class 2, Special Controls

Product Code NDN Cement, Bone, Vertebroplasty
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3027
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Orthopedic devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
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

135
Patients (actual)
9
Sites
Treatment
Purpose
Open label
Masking
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

Regulatory Peers - NDN Cement, Bone, Vertebroplasty

All 107
Devices cleared under the same product code (NDN) and FDA review panel - the closest regulatory comparables to K133372.
INTER V KYPHOPLASTY CATHETER (BALLOON LENGTH: 0 MM), INTERV KYPHOPLASTY CATHETER (BALLOON LENGHT: 15 MM), INTERV KYPHOPL
K132620 · Pan Medical , Ltd. · Apr 2014
MEDINAUT KYPHOPLASTY SYSTEM
K133669 · Imedicom · Apr 2014
KIVA VCF TREATMENT SYSTEM
K132817 · Benvenue Medical, Inc. · Jan 2014
CROSSTREES PVA POD
K130089 · Crosstrees Medical, Inc. · Aug 2013
PARALLAX BALLOON INFLATABLE BONE TAMP-10 MM BALLOON PARALLAX BALLOON INFLATABLE BONE TAMP-15 MM BALLOON PARALLAX BALLOON
K122503 · Neuro Therm, Inc. · Jun 2013
SYNTHES SYNFLATE VERTEVRAL BALLOON SYSTEM
K130146 · Synthes (Usa), LLC · May 2013
K133372 · CROSSTREES PVA POD
Download PDF FDA Summary Crosstrees Medical, I…