Sgarlato Flexible Hinge Toe Implant

• • Terminated Z-2173-2010 FDA Unclassified (pre-2012) ·initiated 1 Mar 2009

  Products with an expiration date of August, 2009 were labeled with an expiration date of May 2013. Additionally, the outer packages were labeled with an incorrect lot number. The outer and inner packages did not match.

510(k) Number

K905795 ↗

FDA Product Code

KWH

Device Class

Class II

Regulation

21 CFR Part 888.3720

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Sgarlato Lesser Toe Implant

  Class II

  FDA 510(k) K884739 Active Cleared 18 May 1989

• Pain Control Infusion Pump

  Class II

  FDA 510(k) K990101 Active Cleared 19 Mar 1999

• Lundeen Subtalar Peg Implant

  Class II

  FDA 510(k) K922292 Active Cleared 23 Oct 1992

• Sgarlato Labs Painfree Pump and Pain Control Infusion Pump

  Class II

  FDA 510(k) K043204 Active Cleared 30 Mar 2005

• First Mpj Continuous Passive Motion Device

  Class I

  FDA 510(k) K926262 Active Cleared 26 Jan 1994

• O'brien Goniometer

  Class I

  FDA 510(k) K926237 Active Cleared 2 Aug 1993

See all devices from Sgarlato Laboratories, Inc. →

• What is the Sgarlato Flexible Hinge Toe Implant used for?

  It is a prosthesis designed to replace or support the toe joint, providing flexion while maintaining strength in the sagittal plane through its flexible hinge design, intended for orthopedic use.

• Is the Sgarlato Flexible Hinge Toe Implant sterile and single-use?

  Yes, the device is supplied as a sterile, single-use implant, meaning it is intended for one-time use during a surgical procedure and should not be reprocessed or reused.

• What material is the Sgarlato Flexible Hinge Toe Implant made of and how is it classified?

  The implant is made of polymer and is classified as a constrained toe prosthesis under regulation number 888.3720, with FDA 510(k) clearance (K905795) received on May 29, 1991.