Cleared Traditional

K152557 - Winch Kyphoplasty(15 and 20 mm) 11 Gauge Balloon Catheters

K152557 is an FDA 510(k) clearance for Winch Kyphoplasty(15 and 20 mm) 11 Gaug..., manufactured by G21, S.R.L.. The device is a Class 2 Orthopedic device with product code NDN cleared through the Traditional 510(k) pathway after a 168-day FDA review.

K152557 · G21, S.R.L. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K152557

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
Combination Product No
PCCP Authorized No
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.

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 Consultant

RQMIS, Inc.
Barry E Sands

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - NDN Cement, Bone, Vertebroplasty

All 106
Devices cleared under the same product code (NDN) and FDA review panel - the closest regulatory comparables to K152557.
13G InterV Kyphoplasty Catheter (Micro) and 11G InterV Kyphoplasty Catheter (Mini-Flex)
K162453 · Pan Medical , Ltd. · Nov 2016
Kyphon HV-R Bone Cement
K160983 · Medtronic, Inc. · Aug 2016
MEDINAUT Kyphoplasty System
K153296 · Imedicom Co., Ltd. · Jul 2016
KYPHON XPEDE Bone Cement
K151227 · Medtronic · Nov 2015
Vertaplex® High Viscosity (HV) Radiopaque Bone Cement
K150582 · Stryker Corporation · Jun 2015
KYPHON (R) HV-R(R) Bone Cement
K150460 · Medtronic Sofamor Danck USA, Inc. · Apr 2015