Cleared Traditional

K233640 - Segmental Plating System (SPS) (FDA 510(k) Clearance)

Also includes:
IdentiTi SPS Interbody System IdentiTi NanoTec SPS Interbody System Transcend SPS Interbody System Transcend NanoTec SPS Interbody System

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

K233640 · Alphatec Spine, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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 663
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K233640.
corra™ cervical plating system
K260570 · Carlsmed, Inc. · Apr 2026
VyPlate™ Anterior Cervical Plate System
K260697 · Vy Spine, LLC · Mar 2026
ANTERIS Thoracolumbar Plate System
K260015 · SpineCraft · Mar 2026
PathLoc Lumbar Plate System
K251940 · L & K Biomed Co., Ltd. · Mar 2026
Aster
K254182 · Osteonic Co., Ltd. · Feb 2026
Lumbar Spine Truss System - Plating Solution (LSTS-PS)
K253201 · 4Web, Inc. · Feb 2026