Cleared Traditional

K103807 - IVAS 2-10MM (10 GUAGE) BALLON CATHETER

K103807 is the FDA 510(k) clearance for IVAS 2-10MM (10 GUAGE) BALLON CATHETER by Stryker Corporation. It is a Class 2 Orthopedic device (product code NDN) cleared through the Traditional 510(k) pathway after a 181-day FDA review.

K103807 · Stryker Corporation · Orthopedic device
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Jun 2011
Decision
181d
Days
Class 2
Risk

K103807 is an FDA 510(k) clearance for the IVAS 2-10MM (10 GUAGE) BALLON CATHETER. Classified as Cement, Bone, Vertebroplasty (product code NDN), Class II - Special Controls.

Submitted by Stryker Corporation (Kalamazoo, US). The FDA issued a Cleared decision on June 28, 2011 after a review of 181 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.

View all Stryker Corporation devices

Submission Details

510(k) Number K103807 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 2010
Decision Date June 28, 2011
Days to Decision 181 days
Submission Type Traditional
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
59d slower than avg
Panel avg: 122d · This submission: 181d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - NDN Cement, Bone, Vertebroplasty

All 49
Devices cleared under the same product code (NDN) and FDA review panel - the closest regulatory comparables to K103807.
STRYKER IVAS BALLOON CATHETER
K123942 · Stryker Corporation · Apr 2013
IVAS BALLOON CATHETER
K113154 · Stryker Corporation · Jan 2012
CONFIDENCE HIGH VISCOSITY SPINAL CEMENT, 16G / 20G
K112907 · Medos International SARL · Dec 2011
KYPHON XPEDE BONE CEMENT
K102397 · Medtronic · Feb 2011
ARTHROCARE PARALLAX CONTOUR VERTEBRAL AUGMENTATION DEVICE
K110183 · Arthrocare Corp. · Feb 2011
AVAMAX VERTEBRAL BALLOON
K103064 · Care Fusion · Jan 2011