POLYGRAFT BGS - Bone Graft Substitute

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

510(k) Number

K041382 ↗

FDA Product Code

JDK

Models / Variants

Polygraft Bgs

Bone Graft Substitute

Device Class

Class II

Regulation

21 CFR Part 878.3300

Advisory Committee

General, Plastic Surgery

FDA Decision

SESU

• Immix Plastifilm

  Class II

  FDA 510(k) K032673 Active Cleared 2 Oct 2003

• Polygraft Bone Graft Substitute

  Class II

  FDA 510(k) K030288 Active Cleared 17 Jul 2003

• Actaeon Probe

  Class II

  FDA 510(k) K013429 Active Cleared 11 Jan 2002

• Trugraft Bgs Syringe, Model 600-041

  Class II

  FDA 510(k) K043172 Active Cleared 7 Jan 2005

• Polygraft Tcp Granules, Cubes, Blocks, Plugs, Wedges, Models 600-023-Xx, 600-025-Xx, 600-026-Xx, 600-022-Xx, 600-027-Xx

  Class II

  FDA 510(k) K033707 Active Cleared 16 Aug 2004

• Oct (Osteochondral Transplant) Comprehensive System

  Class II

  FDA 510(k) K051656 Active Cleared 25 Oct 2005

See all devices from Osteobiologics, Inc. →

• What is Polygraft Bgs Bone Graft Substitute used for?

  Polygraft Bgs Bone Graft Substitute is used by surgeons to fill non-structural bony voids in the extremities, spine, and pelvis. It is packed into defects where it resorbs over time and is replaced by natural bone, providing a scaffold for bone regeneration without providing structural support.

• How is Polygraft Bgs Bone Graft Substitute supplied and is it sterile or reusable?

  Polygraft Bgs Bone Graft Substitute is supplied sterile as porous granules or preformed cylindrical plugs and is intended for single-use only. It must not be resterilized or reused, as doing so could compromise its material integrity and increase the risk of infection or adverse tissue reaction.

• What materials make up Polygraft Bgs Bone Graft Substitute and how does it work in the body?

  Polygraft Bgs Bone Graft Substitute is composed of poly(D,L-lactide-coglycolide), calcium sulfate, polyglycolide fibers, and a surfactant. After implantation, it resorbs gradually via hydrolysis and enzymatic processes, creating space for ingrowth of new bone tissue, which eventually replaces the graft material completely.