Cleared Special

K172214 - Modified Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon Catheters (FDA 510(k) Clearance)

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K172214 · G-21 S.R.L. · Orthopedic device
Download Printable Device Report (PDF)
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Aug 2017
Decision
30d
Days
Class 2
Risk

K172214 is an FDA 510(k) clearance for the Modified Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon Catheters. Classified as Cement, Bone, Vertebroplasty (product code NDN), Class II - Special Controls.

Submitted by G-21 S.R.L. (San Possidonio, IT). The FDA issued a Cleared decision on August 23, 2017 after a review of 30 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.

View all G-21 S.R.L. devices

Submission Details

510(k) Number K172214 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 2017
Decision Date August 23, 2017
Days to Decision 30 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 122d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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 107
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