Cleared Traditional

K240199 - IntraOp Alignment System

K240199 is an FDA 510(k) clearance for IntraOp Alignment System, manufactured by Alphatec Spine, Inc.. The device is a Class 2 Radiology device with product code OWB cleared through the Traditional 510(k) pathway after a 118-day FDA review.

K240199 · Alphatec Spine, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2024
Decision
118d
Days
Class 2
Risk

K240199 is an FDA 510(k) clearance for the IntraOp Alignment System. Classified as Interventional Fluoroscopic X-ray System (product code OWB), Class II - Special Controls.

Submitted by Alphatec Spine, Inc. (Carlsbad, US). The FDA issued a Cleared decision on May 22, 2024 after a review of 118 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1650 - the FDA radiology and imaging software oversight 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 Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Alphatec Spine, Inc. devices

FDA 510(k) Submission Details - K240199

510(k) Number K240199 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 2024
Decision Date May 22, 2024
Days to Decision 118 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
11d slower than avg
Panel avg: 107d · This submission: 118d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OWB Device Classification - Class 2, Special Controls

Product Code OWB Interventional Fluoroscopic X-ray System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1650
Definition Interventional Fluoroscopy
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 Radiology devices follow this clearance model.

Regulatory Peers - OWB Interventional Fluoroscopic X-ray System

All 292
Devices cleared under the same product code (OWB) and FDA review panel - the closest regulatory comparables to K240199.
Alphenix, INFX-8000V/B, INFX-8000V/S, V9.5
K233107 · Canon Medical Systems Corporation · Aug 2024
See Factor CT3™
K233230 · Epica International, Inc. · Jun 2024
O-arm O2 Imaging System
K240465 · Medtronic Navigation, Inc. · Jun 2024
Zenition 90
K240224 · Philips Medical Systems Nederlands B.V. · May 2024
DIGITAL RADIOGRAPHY CXDI-RF Wireless Bl
K232298 · Canon, Inc. · Apr 2024
CIARTIC Move (VB10)
K233748 · Siemens Medical Solutions USA, Inc. · Mar 2024