Cleared Traditional

OLYMPIC Posterior Spinal Fixation System (K182239) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K182239 · Astura Medical, LLC · Orthopedic device
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Oct 2018
Decision
59d
Days
Class 2
Risk

K182239 is an FDA 510(k) clearance for the OLYMPIC Posterior 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 Astura Medical, LLC (Carlsbad, US). The FDA issued a Cleared decision on October 18, 2018 after a review of 59 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. 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.

View all Astura Medical, LLC devices

Submission Details

510(k) Number K182239 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 2018
Decision Date October 18, 2018
Days to Decision 59 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
63d faster than avg
Panel avg: 122d · This submission: 59d
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 447
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K182239.
VersaLink™ Fixation System
K182598 · Premia Spine, Ltd. · Nov 2018
ORTHROS™ Posterior Stabilization System
K180980 · Camber Spine Technologies, LLC · Oct 2018
FUSE Pedicle Screw System
K182283 · Black Box Medical · Oct 2018
PASS LP Spinal System
K182240 · Medicrea International SA · Oct 2018
Cellent Spinal Systems
K172826 · Jiangsu Trauhui Medical Instrument Co., Ltd. · Oct 2018
Prase MIS Spinal System
K182059 · Gbs Commonwealth Co., Ltd. · Oct 2018