Cleared Traditional

K233455 - ARx MIS Spinal Screw System

K233455 is the FDA 510(k) clearance for ARx MIS Spinal Screw System by Life Spine, Inc.. It is a Class 2 Orthopedic device (product code NKB) cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K233455 · Life Spine, Inc. · Orthopedic device
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Dec 2023
Decision
53d
Days
Class 2
Risk

K233455 is an FDA 510(k) clearance for the ARx MIS Spinal Screw System. Classified as Thoracolumbosacral Pedicle Screw System within the NKB classification (a category for thoracolumbosacral pedicle screw systems), Class II - Special Controls.

Submitted by Life Spine, Inc. (Huntley, US). The FDA issued a Cleared decision on December 12, 2023 after a review of 53 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 Life Spine, Inc. devices

Submission Details

510(k) Number K233455 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 2023
Decision Date December 12, 2023
Days to Decision 53 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
69d faster than avg
Panel avg: 122d · This submission: 53d
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 650
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K233455.
INNOVERSE Spinal System
K233960 · Innosys Co., Ltd. · Feb 2024
CarboClear® X Pedicle Screw System
K233944 · CarboFix Orthopedics , Ltd. · Jan 2024
POWEReam 1/4 Drive
K233300 · Stryker Instruments · Dec 2023
TriALTIS™ Spine System
K233684 · Medos International SARL · Dec 2023
Mini-OSTEO Pedicle Fixation System
K231443 · Osteomed Ind?stria E Com?rcio DE Implantes Ltda · Nov 2023
ProMIS Extension Rod System
K232719 · Premia Spine, Ltd. · Nov 2023