Cleared Special

K133713 - CHARLOTTE (TM) SNAP-OFF SCREW

K133713 is an FDA 510(k) clearance for CHARLOTTE (TM) SNAP-OFF SCREW, manufactured by Wrightmedicaltechnologyinc. The device is a Class 2 Orthopedic device with product code HWC cleared through the Special 510(k) pathway after a 92-day FDA review.

K133713 · Wrightmedicaltechnologyinc · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2014
Decision
92d
Days
Class 2
Risk

K133713 is an FDA 510(k) clearance for the CHARLOTTE (TM) SNAP-OFF SCREW. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Wrightmedicaltechnologyinc (Arlington, US). The FDA issued a Cleared decision on March 7, 2014 after a review of 92 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.

FDA 510(k) Submission Details - K133713

510(k) Number K133713 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 2013
Decision Date March 07, 2014
Days to Decision 92 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
30d faster than avg
Panel avg: 122d · This submission: 92d
Pathway characteristics
Modification to existing cleared device.

HWC Device Classification - Class 2, Special Controls

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 1069
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K133713.
PEEK FUSION IMPLANT
K133515 · Mtp Solutions, LLC · Mar 2014
EXTREMITY MEDICAL HAMMERTOE DEVICE
K133636 · Extremity Medical, LLC · Mar 2014
TYBER MEDICAL TRAUMA SCREW
K133842 · Tyber Medical, LLC · Mar 2014
PRO-TOE HAMMERTOE FIXATION SYSTEM
K140148 · Wrightmedicaltechnologyinc · Mar 2014
N-FORCE FIXATION SYSTEM
K132244 · Innovision, Inc. · Mar 2014
FIXOS SCREW SYSTEM
K133451 · Stryker Trauma AG · Feb 2014
K133713 · CHARLOTTE (TM) SNAP-OFF SCREW
Download PDF FDA Summary Wrightmedicaltechnolo…