Cleared Traditional

K112837 - VILEX EZ-STAPLE (MEMORY BONE FIXATION S...

K112837 is an FDA 510(k) clearance for VILEX EZ-STAPLE (MEMORY BONE FIXATION S..., manufactured by Vilex, Inc.. The device is a Class 2 Orthopedic device with product code JDR cleared through the Traditional 510(k) pathway after a 377-day FDA review.

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

FDA 510(k) Submission Details - K112837

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.

JDR Device Classification - Class 2, Special Controls

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 142
Devices cleared under the same product code (JDR) and FDA review panel - the closest regulatory comparables to K112837.
ORTHOHELIX STAPLE SYSTEM
K142148 · Orthohelix Surgical Designs, Inc. · Aug 2014
ORTHOHELIX STAPLE SYSTEM
K130832 · Orthohelix Surgical Designs, Inc. · Aug 2013
MEMORY METAL STAPLES, EASYCLIP
K122113 · Stryker Corp. · Mar 2013
COMPOSITE HITCH SUTURE ANCHOR
K081172 · Biomet Manufacturing Corp · Jul 2008
CAIS STAPLE
K073281 · Depuy Mitek, A Johnson & Johnson Company · May 2008
ARTHREX COMPRESSION STAPLE
K080111 · Arthrex, Inc. · Feb 2008