Cleared Traditional

K182544 - AccelFix Spinal Fixation System

K182544 is the FDA 510(k) clearance for AccelFix Spinal Fixation System by L & K Biomed Co., Ltd.. It is a Class 2 Orthopedic device (product code NKB) cleared through the Traditional 510(k) pathway after a 253-day FDA review.

K182544 · L & K Biomed Co., Ltd. · Orthopedic device
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May 2019
Decision
253d
Days
Class 2
Risk

K182544 is an FDA 510(k) clearance for the AccelFix Spinal Fixation System. Classified as Thoracolumbosacral Pedicle Screw System within the NKB classification (a category for thoracolumbosacral pedicle screw systems), Class II - Special Controls.

Submitted by L & K Biomed Co., Ltd. (Yongin-Si, KR). The FDA issued a Cleared decision on May 28, 2019 after a review of 253 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3070 - 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 L & K Biomed Co., Ltd. devices

Submission Details

510(k) Number K182544 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 2018
Decision Date May 28, 2019
Days to Decision 253 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
131d slower than avg
Panel avg: 122d · This submission: 253d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NKB Thoracolumbosacral Pedicle Screw System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3070
Definition Intended To Provide Immobilization And Stabilization Of Spinal Segments In Thoracic, Lumbar, And Sacral Spine As An Adjunct To Fusion.
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 Peers - NKB Thoracolumbosacral Pedicle Screw System

All 661
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K182544.
VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0
K190545 · Icotec AG · Jun 2019
The JASPER Spinal Fixation System II
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NOVA Minimally Invasive System
K182416 · Baui Biotech Co., Ltd. · Jun 2019
Mariner Outrigger Revision System
K183639 · SeaSpine Orthopedics Corporation · May 2019
KeYi Spinal Fixation System
K190567 · Beijing Keyi Medical Device Technology Co., Ltd. · May 2019
PASS LP Spinal System
K190376 · Medicrea International SA · May 2019