Cleared Special

K013572 - MITEK BIOCRYL INTERFERENCE SCREWS

K013572 is the FDA 510(k) clearance for MITEK BIOCRYL INTERFERENCE SCREWS by Mitek Products. It is a Class 2 Orthopedic device (product code HWC) cleared through the Special 510(k) pathway after a 136-day FDA review.

K013572 · Mitek Products · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2002
Decision
136d
Days
Class 2
Risk

K013572 is an FDA 510(k) clearance for the MITEK BIOCRYL INTERFERENCE SCREWS. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Mitek Products (Norwood, US). The FDA issued a Cleared decision on March 14, 2002 after a review of 136 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Mitek Products devices

Submission Details

510(k) Number K013572 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 2001
Decision Date March 14, 2002
Days to Decision 136 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
14d slower than avg
Panel avg: 122d · This submission: 136d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code HWC Screw, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
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 - HWC Screw, Fixation, Bone

All 584
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K013572.
PRE-LOADED BIOSTINGER HORNET
K020377 · Linvatec Corp. · May 2002
4.0 MM ARTHREX BIO-TENDOESIS SCREW, MODEL AR-1540B
K020043 · Arthrex, Inc. · Apr 2002
SMITH & NEPHEW TWINFIX TI QUICK T
K020159 · Smith & Nephew, Inc. · Mar 2002
MODIFICATION TO STRAIGHT-IN BONE SCREW FIXATION SYSTEM
K020446 · American Medical Systems, Inc. · Mar 2002
LORENZ SELF DRILLING SCREWS
K013954 · Walter Lorenz Surgical, Inc. · Feb 2002
BIOABSORBABLE INTERFERENCE SCREW MEGAFIX
K013107 · Karl Storz Endoscopy · Feb 2002