Cleared Traditional

K172871 - SpineKure Kyphoplasty System

K172871 is an FDA 510(k) clearance for SpineKure Kyphoplasty System, manufactured by Hanchang Co., Ltd.. The device is a Class 2 Orthopedic device with product code NDN cleared through the Traditional 510(k) pathway after a 250-day FDA review.

K172871 · Hanchang Co., Ltd. · Orthopedic device
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Optimized for regulatory review, auditing and printing
May 2018
Decision
250d
Days
Class 2
Risk

K172871 is an FDA 510(k) clearance for the SpineKure Kyphoplasty System. Classified as Cement, Bone, Vertebroplasty (product code NDN), Class II - Special Controls.

Submitted by Hanchang Co., Ltd. (Bucheon-Si, KR). The FDA issued a Cleared decision on May 29, 2018 after a review of 250 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 Hanchang Co., Ltd. devices

FDA 510(k) Submission Details - K172871

510(k) Number K172871 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 2017
Decision Date May 29, 2018
Days to Decision 250 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
128d slower than avg
Panel avg: 122d · This submission: 250d
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

Dt&S Co., Ltd.
GeumHyeon Kim

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 96
Devices cleared under the same product code (NDN) and FDA review panel - the closest regulatory comparables to K172871.
TRACKER Kyphoplasty System
K192335 · GS Medical Co., Ltd. · Dec 2019
VK100 Percutaneous Vertebral Augmentation System
K192403 · Bonwrx, Ltd. · Nov 2019
SpineJack Expansion Kit
K181262 · Vexim SA · Aug 2018
KYPHON HV-R Bone Cement
K180700 · Medtronic Sofamor Danek USA, Inc. · May 2018
Modified Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon Catheters
K172214 · G-21 S.R.L. · Aug 2017
HIGH V+
K161114 · Teknimed Sas · Apr 2017