Cleared Traditional

Spinal Alignment Solutions Pelvic Incidence (PI) Rod System (K242350) - FDA 510(k) Clearance

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

K242350 · Spinal Alignment Solutions, Inc. · Orthopedic device
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Oct 2024
Decision
81d
Days
Class 2
Risk

K242350 is an FDA 510(k) clearance for the Spinal Alignment Solutions Pelvic Incidence (PI) Rod System. Classified as Thoracolumbosacral Pedicle Screw System within the NKB classification (a category for thoracolumbosacral pedicle screw systems), Class II - Special Controls.

Submitted by Spinal Alignment Solutions, Inc. (Tiverton, US). The FDA issued a Cleared decision on October 28, 2024 after a review of 81 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 Spinal Alignment Solutions, Inc. devices

Submission Details

510(k) Number K242350 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 2024
Decision Date October 28, 2024
Days to Decision 81 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
41d faster than avg
Panel avg: 122d · This submission: 81d
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 Consultant

MRC Global, LLC
Christine Scifert

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K242350.
MediRod Pedicle Screw System
K242764 · Cmf Medicon Surgical, Inc. · Nov 2024
Xpine Spinal Fixation System
K243004 · Jeil Medical Corporation · Nov 2024
CarboClear® Hybrid Pedicle Screw System
K243106 · CarboFix Orthopedics , Ltd. · Nov 2024
CD Horizon™ Spinal System
K243007 · Medtronic Sofamor Danek USA, Inc. · Oct 2024
NOVA Minimally Invasive System
K242899 · Baui Biotech Co., Ltd. · Oct 2024
GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal System
K230325 · Greens Surgicals Pvt. , Ltd. · Oct 2024