Cleared Traditional

K143006 - GUARDIAN-SG Inflatable Bone Expander System

K143006 is an FDA 510(k) clearance for GUARDIAN-SG Inflatable Bone Expander System, manufactured by Bm Korea Co., Ltd.. The device is a Class 2 Orthopedic device with product code NDN cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K143006 · Bm Korea Co., Ltd. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2015
Decision
88d
Days
Class 2
Risk

K143006 is an FDA 510(k) clearance for the GUARDIAN-SG Inflatable Bone Expander System. Classified as Cement, Bone, Vertebroplasty (product code NDN), Class II - Special Controls.

Submitted by Bm Korea Co., Ltd. (Gunpo-Si, KR). The FDA issued a Cleared decision on January 16, 2015 after a review of 88 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K143006

510(k) Number K143006 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 2014
Decision Date January 16, 2015
Days to Decision 88 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
34d faster than avg
Panel avg: 122d · This submission: 88d
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

LK Consulting Group USA, Inc.
Priscilla Chung

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 K143006.
KYPHON (R) HV-R(R) Bone Cement
K150460 · Medtronic Sofamor Danck USA, Inc. · Apr 2015
Osseoflex SB Straight Balloon, 10g/4ml, Osseoflex SB Straight Balloon, 10g/2ml
K150607 · Osseon, LLC · Apr 2015
InterV Kyphoplasty Catheter (Balloon Length: 10,15 and 20mm) InterV Kyphoplasty Catheter (Mini) (Balloon Length: 10, 15 and 20mm)
K150322 · Pan Medical , Ltd. · Mar 2015
ZVPLASTY
K141419 · Zavation, LLC · Sep 2014
OSSEOFLEX SB, 10G/4ML, OSSEOFLEX SB, 10G/2ML
K141930 · Osseon, LLC · Aug 2014
KIVA VCF TREATMENT SYSTEM
K141141 · Benvenue Medical, Inc. · Aug 2014