Tantalum Beads Radiographic Marker
FDA 510(k)Class II (US FDA 510(k))
by Biomet, Inc.
Identifiers
- 510(k) Number
- K010348 FDA 510(k)
- FDA Product Code
- NEU FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4300 FDA 510(k)
- Regulation Number
- 878.4300 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Tantalum Beads Radiographic Marker is an implantable radiographic marker designed to enhance visibility during radiographic imaging. These spherical beads, composed of commercially pure, unalloyed tantalum, serve as radiopaque indicators to aid in the precise localization of surgical implants or anatomical structures in procedures such as joint replacement, soft tissue repair, and fracture fixation.
The device is supplied as a sterile, single-use product and is classified under FDA regulation 878.4300 as a Class 2 device in the General and Plastic Surgery category. Cleared via the Traditional 510(k) pathway, it is intended for use in surgical settings where radiographic guidance is required. Each bead measures 0.8 mm in diameter and is intended for implantation, with no indication of MRI compatibility or reusable applications.
Frequently asked questions
What types of surgical procedures are these tantalum beads primarily used to enhance during imaging?
These tantalum beads are designed to improve radiographic visibility during procedures like joint replacements (such as hip or knee arthroplasty), soft tissue repairs, and fracture fixation. Their radiopacity helps surgeons precisely locate implants or anatomical landmarks during these surgeries.
Are these beads reusable, or are they intended for single-use only?
The beads are explicitly supplied as a sterile, single-use product. They are intended for implantation and should not be reused after a single surgical procedure to maintain sterility and safety.
What size are the beads, and how are they packaged for surgical use?
Each bead measures 0.8 mm in diameter and is supplied as a sterile, single-use product. The packaging ensures sterility for surgical use, though specific packaging details (e.g., tray, pouch) are not provided in the data.
Can these beads be used in MRI procedures, or are they MRI-compatible?
The provided data does not mention MRI compatibility for these tantalum beads. Since they are radiopaque (visible on X-rays), their use in MRI would require additional evaluation, and they should not be assumed safe for MRI environments without confirmation from the manufacturer.
How was this device’s regulatory clearance achieved, and what category does it fall under?
The device was cleared via the Traditional 510(k) pathway and is classified as a Class 2 device under FDA regulation 878.4300, falling under the General and Plastic Surgery category. It was determined to be substantially equivalent to a predicate device.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: TANTALUM BEADS - RADIOGRAPHIC MARKER (K010348) — FDA 510 (k) - Innolitics, K010348 FDA 510 (k) - TANTALUM BEADS - RADIOGRAPHIC MARKER, Tantalum Beads - Radiographic Marker - Beudamed, PDF K010348 - Tantalum Beads - Radiographic Marker
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K010348 | Class II | Active |
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Manufacturer
- Manufacturer
- Biomet, Inc.
Sources (1)
- FDA 510(k) K010348 24 fields · synced Sep 19, 2026