Synthes Stainless Steel Elastic Intramedullary Nail System

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

Full name

Synthes (USA) Stainless Steel Elastic Intramedullary Nail System

510(k) Number

K081452 ↗

FDA Product Code

HSB

Device Class

Class II

Regulation

21 CFR Part 888.3020

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 Stainless Steel Elastic Intramedullary Nail System used for?

  This system is designed for orthopedic procedures requiring flexible intramedullary stabilization of long-bone fractures. The elastic nails fit into the medullary canal to support bone healing, making them particularly useful in pediatric or adult cases where gentle fixation is needed to accommodate bone growth or remodeling.

• Is the Synthes Elastic Intramedullary Nail System intended for single-use or reuse?

  The device is explicitly intended for single-use in orthopedic surgical settings. This ensures sterility and reduces the risk of infection or cross-contamination, aligning with best practices for medical devices.

• How is the Synthes Elastic Intramedullary Nail System supplied, and what sterility standards apply?

  The system is supplied sterile and packaged for immediate surgical use. Sterility is maintained through validated manufacturing processes, ensuring it meets regulatory requirements for orthopedic implants before reaching the clinical setting.

• What materials are used in the Synthes Elastic Intramedullary Nail System?

  The nails are constructed from stainless steel, a durable and biocompatible material chosen for its strength, flexibility, and resistance to corrosion—critical properties for intramedullary fixation in long-bone fractures.

• How should the Synthes Elastic Intramedullary Nail System be stored?

  Storage must comply with sterile medical device protocols to preserve integrity. The packaging should remain unopened until use, and the device should be stored in a clean, dry environment away from direct sunlight or extreme temperatures to prevent contamination or degradation.