Cleared Traditional

K233640 - Segmental Plating System (SPS)

Also marketed or referenced as:
IdentiTi SPS Interbody System IdentiTi NanoTec SPS Interbody System Transcend SPS Interbody System Transcend NanoTec SPS Interbody System

K233640 is the FDA 510(k) clearance for Segmental Plating System (SPS) by Alphatec Spine, Inc.. It is a Class 2 Orthopedic device (product code KWQ) cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K233640 · Alphatec Spine, Inc. · Orthopedic device
Download Printable Device Report (PDF)
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Feb 2024
Decision
101d
Days
Class 2
Risk

K233640 is an FDA 510(k) clearance for the Segmental Plating System (SPS). Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Alphatec Spine, Inc. (Carlsbad, US). The FDA issued a Cleared decision on February 22, 2024 after a review of 101 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3060 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Alphatec Spine, Inc. devices

Submission Details

510(k) Number K233640 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 2023
Decision Date February 22, 2024
Days to Decision 101 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
21d faster than avg
Panel avg: 122d · This submission: 101d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KWQ Appliance, Fixation, Spinal Intervertebral Body
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3060
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 - KWQ Appliance, Fixation, Spinal Intervertebral Body

All 421
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K233640.
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Curiteva Thoracolumbar Plate System
K233360 · Curiteva, Inc. · Feb 2024
MONDRIAN™ Anterior Lumbar Plate System
K231715 · Ctl Medical Corporation · Jan 2024
ADIRA™ Lateral Plate System
K233735 · Globus Medical, Inc. · Jan 2024
VICTORY™ Lumbar Plate System
K232318 · Globus Medical, Inc. · Oct 2023