Collagraft Bone Graft Matrix

No FDA recalls found in the data synced 6 Oct 2026.

Full name

Collagraft(Tm) Bone Graft Matrix

Trade Name

Collagraft(Tm) Bone Graft Substitute

Generic Name

Filler, bone void, non-osteoinduction

PMA Number

P900039 ↗

FDA Product Code

MBS

Device Class

Class III

Advisory Committee

Orthopedic

FDA Decision

APRL

• Collagraft Strip Bone Graft Matrix (for Use As a Bone Filler), Model 1X, 3X, 6X (1, 3 or 6 Strips per Box)

  Class II

  FDA 510(k) K000122 Active Cleared 20 Sep 2001

• What types of bone defects is the Collagraft Bone Graft Matrix specifically designed to address in orthopedic procedures?

  The Collagraft Bone Graft Matrix is engineered to fill bone voids or defects where structural support is needed, particularly in orthopedic applications. It is classified as a non-osteoinductive graft substitute, meaning it does not stimulate new bone formation on its own but instead provides a scaffold to support existing bone regeneration processes. It is ideal for scenarios where a temporary framework is required to bridge gaps or stabilize areas during healing.

• Is the Collagraft Bone Graft Matrix intended for reuse in multiple surgical procedures, or is it meant to be used only once?

  The Collagraft Bone Graft Matrix is explicitly supplied as a **single-use** device. Since it is sterile and designed for surgical settings, reusing it would compromise sterility and potentially introduce contamination risks, which could affect patient safety and efficacy. Always follow sterile medical device protocols to maintain its integrity.

• How should the Collagraft Bone Graft Matrix be stored to ensure it remains effective for surgical use?

  As a sterile medical device, the Collagraft Bone Graft Matrix must be stored in accordance with sterile medical device protocols. This typically includes keeping it in its original, unopened packaging in a clean, dry environment, away from direct sunlight or extreme temperatures. Proper storage ensures the matrix retains its structural integrity and sterility until use.

• What regulatory pathway does the Collagraft Bone Graft Matrix follow, and how does this affect its availability?

  The Collagraft Bone Graft Matrix is regulated under an **FDA Premarket Approval (PMA)** with PMA number **P900039**, classifying it as a **Class III** device. This means it undergoes rigorous review by the FDA to ensure safety and effectiveness before being approved for commercial distribution. Availability is governed by this approval, and only authorized healthcare providers can use it in surgical settings as intended.