Cleared Traditional

K172871 - SpineKure Kyphoplasty System

K172871 is the FDA 510(k) clearance for SpineKure Kyphoplasty System by Hanchang Co., Ltd.. It is a Class 2 Orthopedic device (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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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

Submission Details

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.

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 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 49
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
Kyphon Xpede Bone Cement
K163032 · Medtronic, Inc. · Feb 2017
CONCORD Plus Radiopaque Bone Cement
K162618 · Globus Medical, Inc. · Jan 2017