Synthes LCP Curved Plates

• • Terminated Z-0409-2014 FDA Class II ·initiated 30 Jul 2013

  The Synthes 4.5 mm LCP Curved Condylar Plate was recalled because a Straight Condylar Plate is etched with a Curved Condylar Plate part number.

Full name

Synthes (USA) Lcp Curved Plates

510(k) Number

K041911 ↗

FDA Product Code

KTT

Device Class

Class II

Regulation

21 CFR Part 888.3030

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Synthes Light Guide

  Class II

  FDA 510(k) K993314 Active Cleared 6 Dec 1999

• Synthes Locking Hand Plates

  Class II

  FDA 510(k) K092247 Active Cleared 25 Sep 2009

• Synthes Matrix Mis Rods

  Class II

  FDA 510(k) K093668 Active Cleared 9 Mar 2010

• Synthes Lcp Proximal Tibia Plate

  Class II

  FDA 510(k) K011978 Active Cleared 9 Aug 2001

• Synthes Locking Calcaneal Plates

  Class II

  FDA 510(k) K991407 Active Cleared 11 Jun 1999

• Volar Distal Radius Plate

  Class II

  FDA 510(k) K953644 Active Cleared 8 Mar 1996

See all devices from Synthes (Usa) →

• What are the Synthes LCP Curved Plates used for?

  The Synthes LCP Curved Plates are designed for internal fixation in orthopedic surgery to stabilize bone fragments during fracture repair, non-unions, malunions, or osteotomies. Their curved shape aligns with anatomical contours, while locking screw holes and dynamic compression features ensure secure fixation, reducing the risk of displacement during healing.

• Are these plates supplied sterile and intended for single-use?

  Yes, the Synthes LCP Curved Plates are supplied sterile and intended for single-use only. This ensures patient safety by preventing cross-contamination and maintains the integrity of the device’s sterile barrier, which is critical for surgical applications where infection control is paramount.

• What materials are used in the construction of these plates?

  The plates are constructed from either stainless steel or titanium, both of which are biocompatible metals commonly used in orthopedic implants. Stainless steel offers high strength and corrosion resistance, while titanium provides a lighter weight and excellent biocompatibility, reducing the risk of adverse reactions in patients.

• Can these plates be used in MRI environments?

  Yes, the Synthes LCP Curved Plates are compatible with MRI environments, though facilities should verify specific safety parameters before use. This compatibility is important for postoperative imaging, as it allows for non-invasive monitoring of bone healing without removing the fixation hardware.

• What sizes and configurations are available for these plates?

  The Synthes LCP Curved Plates come in predefined sizes and configurations tailored to specific anatomical regions and clinical needs. These variations ensure proper alignment and fixation, allowing surgeons to select the optimal plate for the patient’s unique fracture pattern or surgical requirement.