Cleared Traditional

K133218 - Crystal ® (FDA 510(k) Clearance)

Also includes:
Mosaic ® Vertu ®

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

K133218 · Spinal Elements, Inc. · Orthopedic device
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Dec 2014
Decision
418d
Days
Class 2
Risk

K133218 is an FDA 510(k) clearance for the Crystal ®. Classified as Intervertebral Fusion Device With Integrated Fixation, Cervical (product code OVE), Class II - Special Controls.

Submitted by Spinal Elements, Inc. (Carlsbad, US). The FDA issued a Cleared decision on December 10, 2014 after a review of 418 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Orthopedic submissions.

View all Spinal Elements, Inc. devices

Submission Details

510(k) Number K133218 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 2013
Decision Date December 10, 2014
Days to Decision 418 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
296d slower than avg
Panel avg: 122d · This submission: 418d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OVE Intervertebral Fusion Device With Integrated Fixation, Cervical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3080
Definition Intended To Stabilize Cervical Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft With Or Without Supplemental Fixation.
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 - OVE Intervertebral Fusion Device With Integrated Fixation, Cervical

All 159
Devices cleared under the same product code (OVE) and FDA review panel - the closest regulatory comparables to K133218.
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