Cleared Traditional

K133906 - C-JAWS CERVICAL COMPRESSIVE STAPLE (FDA 510(k) Clearance)

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

K133906 · Medicrea International · Orthopedic device
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Jul 2014
Decision
213d
Days
Class 2
Risk

K133906 is an FDA 510(k) clearance for the C-JAWS CERVICAL COMPRESSIVE STAPLE. Classified as Anterior Staple As Supplemental Fixation For Fusion (product code PHQ), Class II - Special Controls.

Submitted by Medicrea International (Washington, US). The FDA issued a Cleared decision on July 24, 2014 after a review of 213 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3060 - 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.

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Submission Details

510(k) Number K133906 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2013
Decision Date July 24, 2014
Days to Decision 213 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
91d slower than avg
Panel avg: 122d · This submission: 213d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PHQ Anterior Staple As Supplemental Fixation For Fusion
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3060
Definition Anterior Cervical Device For Supplemental Fixation To Support A Fusion.
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.