PRO Osteon Implant 500 Porous Hydroxyapatite Bone Graft Substitute Blocks & Granules

No FDA recalls on record, checked 6 Oct 2026.

Trade Name

Pro Osteon Implant 500 Hydroxyapatite Bone Void Filler

Generic Name

Calcium salt bone void filler, drillable, non-screw augmentation

PMA Number

P860005 ↗

FDA Product Code

OIS

Device Class

Class II

Regulation

21 CFR Part 888.3045

Advisory Committee

Orthopedic

FDA Decision

APRL

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• Interpore Cylindrical Hex Implant, 3.3 Mm Diameter

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• Interpore 200 Porous Hydroxyapatite

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  FDA 510(k) K860983 Active Cleared 23 May 1986

See all devices from Interpore Intl. →

• What types of bone defects or voids is the PRO Osteon Implant 500 designed to address in orthopedic procedures?

  The PRO Osteon Implant 500 is specifically designed as a **Calcium Salt Bone Void Filler** to replace or augment bone voids in orthopedic applications. Its porous hydroxyapatite structure promotes osseointegration, making it suitable for structural support in areas where bone grafting is required, such as defects, cavities, or gaps in bone tissue.

• Is the PRO Osteon Implant 500 intended for use in procedures where screws or fixation hardware are involved?

  No, the PRO Osteon Implant 500 is classified as a **non-screw augmentation** device. While it provides structural support and promotes bone integration, it is not designed to be secured with screws or other fixation hardware. Instead, its porous design relies on osseointegration for stability.

• How is the PRO Osteon Implant 500 supplied, and what does this mean for clinical workflow?

  The PRO Osteon Implant 500 is supplied as **sterile, single-use blocks and granules**, ensuring it is ready for immediate surgical use without additional sterilization. This design minimizes contamination risks and simplifies inventory management, as each package is intended for one-time use only.

• What regulatory pathway does the PRO Osteon Implant 500 follow, and how does this affect its availability?

  The PRO Osteon Implant 500 is authorized under an **FDA Premarket Approval (PMA) with the number P860005**, which is the highest level of regulatory scrutiny for medical devices. This approval ensures it meets stringent standards for safety and effectiveness as a Class II orthopedic device, confirming its compliance for clinical use in the U.S. market.

• Are there different sizes or forms available for the PRO Osteon Implant 500, and how might this impact surgical planning?

  Yes, the PRO Osteon Implant 500 is available in multiple **sizes and forms**, including both blocks and granules, as indicated by its **product code (OIS)**. This variety allows surgeons to select the appropriate form and dimensions to match the specific bone defect or void, ensuring optimal fit and integration during orthopedic procedures.