Cleared Special

K183168 - OpenLoc-L Spinal Fixation System

K183168 is the FDA 510(k) clearance for OpenLoc-L Spinal Fixation System by L & K Biomed Co., Ltd.. It is a Class 2 Orthopedic device (product code NKB) cleared through the Special 510(k) pathway after a 25-day FDA review.

K183168 · L & K Biomed Co., Ltd. · Orthopedic device
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Dec 2018
Decision
25d
Days
Class 2
Risk

K183168 is an FDA 510(k) clearance for the OpenLoc-L 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 December 11, 2018 after a review of 25 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3070 - 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.

View all L & K Biomed Co., Ltd. devices

Submission Details

510(k) Number K183168 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 2018
Decision Date December 11, 2018
Days to Decision 25 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
97d faster than avg
Panel avg: 122d · This submission: 25d
Pathway characteristics
Modification to existing cleared device.

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 K183168.
CBT Screw Fixation System
K181824 · U&I Corporation · Dec 2018
LEUCADIA AUTOLOK™ Pedicle Screw System
K182339 · Clearview Orthopedic Development, LLC · Dec 2018
Salvo™ Spine System
K182954 · Spine Wave, Inc. · Dec 2018
Mega Plus Spine System
K183080 · Bk Meditech, Co., Ltd. · Dec 2018
C-Zero Pedicle Screw System, Freedom Pedicle Screw System
K180754 · Signature Orthopaedics Pty, Ltd. · Dec 2018
PathLoc-L MIS Spinal System
K183117 · L & K Biomed Co., Ltd. · Nov 2018