Synthes Titanium Alloy High Tibial Osteotomy System

No FDA recalls found in the data synced 22 Oct 2026.

Full name

Synthes Titanium (Ti) Alloy High Tibial Osteotomy (Hto) System

510(k) Number

K963325 ↗

FDA Product Code

HRS

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 is the Synthes Titanium Alloy High Tibial Osteotomy System used for?

  This system is designed to correct leg malalignments—specifically varus or valgus deformities—that contribute to unicompartmental osteoarthritis. By performing a high tibial osteotomy, it restores mechanical axis balance in the knee joint, promoting proper alignment and bone healing through the use of titanium alloy plates and locking screws.

• How is the Synthes Titanium Alloy High Tibial Osteotomy System supplied?

  The system is supplied as a sterile, single-use surgical implant and instrument set. This ensures compliance with sterile surgical protocols and prevents cross-contamination, as the components are intended for one-time use in orthopedic procedures.

• Is this system reusable or single-use?

  The Synthes Titanium Alloy High Tibial Osteotomy System is explicitly designed for single-use only. This is a standard practice for orthopedic implants to maintain sterility and reduce infection risks, requiring each set to be discarded after a single surgical procedure.

• What materials are used in the Synthes Titanium Alloy High Tibial Osteotomy System?

  The system is constructed entirely from titanium alloy, a durable and biocompatible material chosen for its strength, corrosion resistance, and ability to integrate with bone over time. This ensures long-term stability at the osteotomy site.

• How should the Synthes Titanium Alloy High Tibial Osteotomy System be stored?

  Storage must follow sterile surgical instrument protocols to preserve the system’s integrity before use. This includes maintaining sealed packaging, protecting from contamination, and adhering to manufacturer guidelines to ensure the sterility and functionality of the titanium alloy plates and screws.