Cleared Special

K172214 - Modified Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon Catheters

K172214 is an FDA 510(k) clearance for Modified Winch Kyphoplasty (15 and 20 m..., manufactured by G-21 S.R.L.. The device is a Class 2 Orthopedic device with product code NDN cleared through the Special 510(k) pathway after a 30-day FDA review.

K172214 · G-21 S.R.L. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K172214

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 122d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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.
Paul Speidel

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 107
Devices cleared under the same product code (NDN) and FDA review panel - the closest regulatory comparables to K172214.
SpineJack Expansion Kit
K181262 · Vexim SA · Aug 2018
SpineKure Kyphoplasty System
K172871 · Hanchang Co., Ltd. · May 2018
KYPHON HV-R Bone Cement
K180700 · Medtronic Sofamor Danek USA, Inc. · May 2018
HIGH V+
K161114 · Teknimed Sas · Apr 2017
Kyphon Xpede Bone Cement
K163032 · Medtronic, Inc. · Feb 2017
DCM Kyphoplasty System
K162283 · Dragon Crown Medical Co., Ltd. · Feb 2017