# K090581: Tantalum Bead Set, Model P003175

- Pathway: 510(k) (Traditional)
- Applicant: Halifax Biomedical, Inc.
- Decided: Aug 21, 2009 after 171 days
- Product code: NEU (Marker, Radiographic, Implantable)
- Device class: 2
- Regulation: 21 CFR 878.4300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K010348 (2001). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010348: Tantalum Beads - Radiographic Marker, Biomet, Inc. (2001) Summary page 1.

## Indications for use
Tantalum bead implants are used as radio-opaque markers and may be implanted into bone or soft tissue. These devices are used to measure movement of implants after surgery with the aid of an x-ray system. Implant surgery associated with the use of radiographic markers may include total joint replacement procedures, soft tissue repair and bone fracture fixation procedures.

Source page: https://510kreport.com/device/K090581
Methodology: https://510kreport.com/methodology