Cleared Traditional

K113477 - IVAS 20MM (10 GAUGE) BALLOON CATHETER

K113477 is an FDA 510(k) clearance for IVAS 20MM (10 GAUGE) BALLOON CATHETER, manufactured by Stryker Instruments, Instruments Div.. The device is a Class 2 Orthopedic device with product code NDN cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K113477 · Stryker Instruments, Instruments Div. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2012
Decision
44d
Days
Class 2
Risk

K113477 is an FDA 510(k) clearance for the IVAS 20MM (10 GAUGE) BALLOON CATHETER. Classified as Cement, Bone, Vertebroplasty (product code NDN), Class II - Special Controls.

Submitted by Stryker Instruments, Instruments Div. (Kalamazoo, US). The FDA issued a Cleared decision on January 6, 2012 after a review of 44 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Stryker Instruments, Instruments Div. devices

FDA 510(k) Submission Details - K113477

510(k) Number K113477 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 2011
Decision Date January 06, 2012
Days to Decision 44 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
78d faster than avg
Panel avg: 122d · This submission: 44d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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. 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 53
Devices cleared under the same product code (NDN) and FDA review panel - the closest regulatory comparables to K113477.
Vertaplex® High Viscosity (HV) Radiopaque Bone Cement
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K102397 · Medtronic · Feb 2011