Cleared Special

K200794 - AccelFix Spinal Fixation System

K200794 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 Special 510(k) pathway after a 208-day FDA review.

K200794 · L & K Biomed Co., Ltd. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2020
Decision
208d
Days
Class 2
Risk

K200794 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 October 20, 2020 after a review of 208 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. 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. Standard predicate reliance. 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 K200794 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 2020
Decision Date October 20, 2020
Days to Decision 208 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
86d slower than avg
Panel avg: 122d · This submission: 208d
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 K200794.
Cannulated Power Driver Attachment
K202528 · K2m, Inc. · Oct 2020
Wiltrom Spinal Fixation System
K202894 · Wiltrom Corporation Limited · Oct 2020
Trivergent Spinal Fixation System
K201427 · Benvenue Medical, Inc. · Oct 2020
CD Horizon Spinal System
K202771 · Medtronic · Oct 2020
Invictus™ OsseoScrew® System
K202327 · Alphatec Spine, Inc. · Oct 2020
KHEIRON® Spinal Fixation System
K201659 · S.M.A.I.O · Oct 2020