Cleared Traditional

K152557 - Winch Kyphoplasty(15 and 20 mm) 11 Gauge Balloon Catheters (FDA 510(k) Clearance)

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K152557 · G21, S.R.L. · Orthopedic device
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Feb 2016
Decision
168d
Days
Class 2
Risk

K152557 is an FDA 510(k) clearance for the Winch Kyphoplasty(15 and 20 mm) 11 Gauge Balloon Catheters. Classified as Cement, Bone, Vertebroplasty (product code NDN), Class II - Special Controls.

Submitted by G21, S.R.L. (San Possidonio, IT). The FDA issued a Cleared decision on February 23, 2016 after a review of 168 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 G21, S.R.L. devices

Submission Details

510(k) Number K152557 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 2015
Decision Date February 23, 2016
Days to Decision 168 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
46d slower than avg
Panel avg: 122d · This submission: 168d
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 107
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