Cleared Traditional

SPIRA Open Matrix ALIF (K162986) - FDA 510(k) Clearance

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

K162986 · Camber Spine Technologies · Orthopedic device
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Jun 2017
Decision
228d
Days
Class 2
Risk

K162986 is an FDA 510(k) clearance for the SPIRA Open Matrix ALIF. 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 (Wayne, US). The FDA issued a Cleared decision on June 12, 2017 after a review of 228 days - an extended review 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: 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 K162986 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 27, 2016
Decision Date June 12, 2017
Days to Decision 228 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
106d slower than avg
Panel avg: 122d · This submission: 228d
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 465
Devices cleared under the same product code (MAX) and FDA review panel - the closest regulatory comparables to K162986.
CRESCENT™ Spinal System
K171031 · Medtronic Sofamor Danek · Jul 2017
NuVasive® CoRoent® Thoracolumbar System
K170962 · Nu Vasive, Incorporated · Jun 2017
FUSE Spinal System
K171468 · Medtronic Sofamor Danek · Jun 2017
DIVERGENCE-L ANTERIOR/OBLIQUE LUMBAR FUSION SYSTEM
K162212 · Medtronic Sofamor Danek USA, Inc. · May 2017
MOJAVE Expandable Interbody System
K171097 · K2m, Inc. · May 2017
NuVasive CoRoent Ti-C System
K163707 · Nu Vasive, Incorporated · May 2017