Synthes (USA) Chronos

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

510(k) Number

K041350 ↗

FDA Product Code

GXP

Device Class

Class II

Regulation

21 CFR Part 882.5300

Advisory Committee

Neurology

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 Chronos Bone Void Filler used for?

  The Chronos Bone Void Filler is designed to fill skeletal bony voids in extremities, the spine, and pelvis. It serves as an osteoconductive, resorbable alternative to methyl methacrylate, promoting bone regeneration through its porous β-Tricalcium Phosphate (TCP) composition. This makes it suitable for surgical applications where bone integrity must be restored, such as post-resection or trauma cases.

• How is the Chronos Bone Void Filler supplied?

  This device is supplied sterile and comes in multiple forms, including granules, blocks, wedges, and cylinders. The variety of shapes allows for tailored use depending on the anatomical site and void size, ensuring flexibility during surgical procedures. The sterile packaging adheres to standard medical device protocols to maintain integrity until use.

• Is the Chronos Bone Void Filler single-use or reusable?

  The Chronos Bone Void Filler is intended for single-use only. As a resorbable and sterile device, it is not designed for reuse or reprocessing. Reuse could compromise sterility and integrity, posing risks to patient safety. Always follow sterile handling protocols as outlined in the device instructions.

• What are the key differences between Chronos and methyl methacrylate?

  Chronos is a resorbable, osteoconductive alternative to methyl methacrylate, composed of β-Tricalcium Phosphate (TCP). Unlike permanent implants like methyl methacrylate, Chronos gradually resorbs as new bone forms, reducing the need for secondary procedures. It also avoids the risks associated with permanent implants, such as long-term biocompatibility concerns or the need for removal. Chronos is specifically FDA-cleared as a substitute for methyl methacrylate in cranioplasty applications.

• How should the Chronos Bone Void Filler be stored?

  The Chronos Bone Void Filler must be stored according to sterile medical device protocols to preserve its integrity and sterility. This includes keeping it in its original packaging, away from moisture, extreme temperatures, and direct sunlight. Always refer to the manufacturer’s instructions for precise storage conditions, as improper storage could compromise the device’s performance or safety.