Cleared Traditional

SPIRA® Posterior Lumbar Spacers (K230942) - FDA 510(k) Clearance

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

K230942 · Camber Spine Technologies · Orthopedic device
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Jul 2023
Decision
99d
Days
Class 2
Risk

K230942 is an FDA 510(k) clearance for the SPIRA® Posterior Lumbar Spacers. 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 Camber Spine Technologies (King Of Prussia, US). The FDA issued a Cleared decision on July 11, 2023 after a review of 99 days - within the typical 510(k) review window.

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: 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 Camber Spine Technologies devices

Submission Details

510(k) Number K230942 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 2023
Decision Date July 11, 2023
Days to Decision 99 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
23d faster than avg
Panel avg: 122d · This submission: 99d
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 464
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K230942.
Exceed™ Biplanar Expandable Interbody System
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Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody System
K231438 · Alphatec Spine, Inc. · Jul 2023
NanoHive Medical Lumbar Interbody System
K231241 · NanoHive Medical, LLC · Jul 2023
Ventana™ L Spinal System
K231252 · Spinal Elements, Inc. · Jun 2023
Solar Lumbar Interbody Fusion System
K231199 · Degen Medical · Jun 2023
RODIN™ Expandable Lumbar Cage System
K231359 · Ctl Medical Corporation · Jun 2023