Progenix

No FDA recalls found in the data synced 5 Oct 2026.

510(k) Number

K082463 ↗

FDA product code

NUN

FDA applicant

Medtronic Sofamor Danek

Device class

Class II

Regulation

21 CFR Part 872.3930

Advisory committee

Dental

FDA decision

SESE Substantially Equivalent

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See all devices from Medtronic Sofamor Danek, Inc. →

• What is the Progenix Bone Grafting Material used for?

  Progenix is designed as a bone graft extender and void filler to support natural bone regeneration in bony defects or gaps within the skeletal system. It is specifically intended for use in dental and orthopedic procedures—such as spinal, pelvic, or extremity surgeries—where additional bone support is required but mechanical stability is not provided by the material itself. It helps bridge gaps where natural bone healing may otherwise be insufficient.

• How is the Progenix Bone Grafting Material supplied and prepared for use?

  Progenix is supplied as a single-use, ready-to-use product, meaning it does not require additional preparation or sterilization by the clinician before surgical application. It is intended to be handled and applied under sterile surgical protocols, as it is not sterilized for reuse. The packaging ensures sterility for one-time surgical use only.

• Is Progenix derived from human sources, and what does that mean for its use?

  Yes, Progenix is derived from human sources, classified as a Bone Grafting Material under FDA product code NUN. This means it is processed from human tissue to provide biocompatible support for bone regeneration. Its human origin ensures compatibility with the patient’s own biological processes, but it does not replace structural support—it acts as an extender to aid natural healing in bony defects.

• Can Progenix be reused after a single surgical procedure?

  No, Progenix is explicitly designed for single-use only. The material is not sterilized for reuse, and its packaging is intended to maintain sterility for one surgical application. Reusing it would violate sterile surgical protocols and could compromise patient safety. Always follow the manufacturer’s instructions for single-use disposal after use.

• What regulatory clearance does Progenix hold, and how does that affect its use?

  Progenix holds FDA 510(k) clearance (K082463) under the classification of Bone Grafting Material, Human Source, and is categorized as a Class II medical device with special controls. This clearance confirms it meets FDA standards for safety and effectiveness as a bone graft extender. Clinicians should adhere to the approved labeling and surgical guidelines provided by Medtronic Sofamor Danek to ensure compliance with regulatory requirements.