Cleared Traditional

Redi-Spine (K181584) - FDA 510(k) Clearance

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

K181584 · Innovative Surgical Designs, Inc. · Orthopedic device
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Aug 2018
Decision
56d
Days
Class 2
Risk

K181584 is an FDA 510(k) clearance for the Redi-Spine. Classified as Thoracolumbosacral Pedicle Screw System within the NKB classification (a category for thoracolumbosacral pedicle screw systems), Class II - Special Controls.

Submitted by Innovative Surgical Designs, Inc. (Bloomington, US). The FDA issued a Cleared decision on August 10, 2018 after a review of 56 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 Innovative Surgical Designs, Inc. devices

Submission Details

510(k) Number K181584 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 2018
Decision Date August 10, 2018
Days to Decision 56 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 122d · This submission: 56d
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 K181584.
CD HORIZON™ Spinal System
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K180179 · Orthofix, Inc. · Aug 2018
Zenius™, Iliad™ and Kora™ Spinal Fixation Systems
K181978 · Medyssey USA, Inc. · Aug 2018
Kodiak Spinal Fixation System
K181677 · Alphatec Spine, Inc. · Aug 2018
Stowe Pedicle Screw System
K181554 · Black Box Medical · Jul 2018
TREND II Spinal Fixation System- STEP Series
K180226 · Paonan Biotech Co., Ltd. · Jul 2018