Cleared Traditional

K231438 - Calibrate PSX Interbody System

K231438 is the FDA 510(k) clearance for Calibrate PSX Interbody System by Alphatec Spine, Inc.. It is a Class 2 Orthopedic device (product code MAX) cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K231438 · Alphatec Spine, Inc. · Orthopedic device
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Jul 2023
Decision
57d
Days
Class 2
Risk

K231438 is an FDA 510(k) clearance for the Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody System. Classified as Intervertebral Fusion Device With Bone Graft, Lumbar within the MAX classification (a category for intervertebral fusion devices and spinal implants), Class II - Special Controls.

Submitted by Alphatec Spine, Inc. (Carlsbad, US). The FDA issued a Cleared decision on July 13, 2023 after a review of 57 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3080 - 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 Alphatec Spine, Inc. devices

Submission Details

510(k) Number K231438 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 2023
Decision Date July 13, 2023
Days to Decision 57 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
65d faster than avg
Panel avg: 122d · This submission: 57d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3080
Definition Intended To Stabilize Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft.
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 - MAX Intervertebral Fusion Device With Bone Graft, Lumbar

All 603
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K231438.
AccelFix Lumbar Expandable Cage System
K231680 · L & K Biomed Co., Ltd. · Aug 2023
Lumbar Expandable lnterbody Spacers -Additional Indications/Implants
K221894 · Globus Medical, Inc. · Aug 2023
Exceed™ Biplanar Expandable Interbody System
K231275 · Spine Wave, Inc. · Jul 2023
NanoHive Medical Lumbar Interbody System
K231241 · NanoHive Medical, LLC · Jul 2023
SPIRA® Posterior Lumbar Spacers
K230942 · Camber Spine Technologies · Jul 2023
Ventana™ L Spinal System
K231252 · Spinal Elements, Inc. · Jun 2023