Skip to content

Charlotte Snap-Off Screw

by Wrightmedicaltechnologyinc 510(k)

Active United States

510(k) K133713

Overview

The Charlotte Snap-Off Screw is a bone fixation screw designed for orthopedic use. It features a snap-off mechanism that allows the driving shank to be broken off, leaving a smooth screw head after implantation.

This device is supplied in 2.0mm diameter with lengths of 11mm, 12mm, and 14mm, and in 2.7mm diameter with lengths of 13mm, 15mm, and 17mm. It received FDA 510(k) clearance (K133713) on March 7, 2014, and is classified as a Class II bone fixation screw under product code HWC with special controls.

AI-generated from registry data, 1 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK133713 Date7 Mar 2014ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

Full name
Charlotte (Tm) Snap-Off Screw
510(k) Number
FDA Product Code
HWC
Device Class
Class II
Regulation
21 CFR Part 888.3040
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Other devices from Wrightmedicaltechnologyinc

See all devices from Wrightmedicaltechnologyinc →

Questions

  • What is the Charlotte Snap-Off Screw used for?

    The Charlotte Snap-Off Screw is a bone fixation screw designed for orthopedic use, intended to stabilize bone fragments during healing by providing secure internal fixation after implantation.

  • How is the Charlotte Snap-Off Screw supplied and what sizes are available?

    It is supplied in two diameters: 2.0mm with lengths of 11mm, 12mm, and 14mm, and 2.7mm with lengths of 13mm, 15mm, and 17mm, offering multiple size options for different anatomical needs.

  • Does the Charlotte Snap-Off Screw have a special feature after implantation?

    Yes, it features a snap-off mechanism that allows the driving shank to be broken off during surgery, leaving a smooth screw head to reduce soft tissue irritation post-implantation.