Cleared Traditional

K112837 - VILEX EZ-STAPLE (MEMORY BONE FIXATION STAPLE) (FDA 510(k) Clearance)

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

K112837 · Vilex, Inc. · Orthopedic device
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Oct 2012
Decision
377d
Days
Class 2
Risk

K112837 is an FDA 510(k) clearance for the VILEX EZ-STAPLE (MEMORY BONE FIXATION STAPLE). Classified as Staple, Fixation, Bone (product code JDR), Class II - Special Controls.

Submitted by Vilex, Inc. (Mcminnville, US). The FDA issued a Cleared decision on October 9, 2012 after a review of 377 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - 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. Elevated predicate reliance profile. 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 Vilex, Inc. devices

Submission Details

510(k) Number K112837 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2011
Decision Date October 09, 2012
Days to Decision 377 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
255d slower than avg
Panel avg: 122d · This submission: 377d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JDR Staple, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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 - JDR Staple, Fixation, Bone

All 230
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