# K103417: Halifax Biomedical Tanatlum Bead Set

- Pathway: 510(k) (Special)
- Applicant: Halifax Biomedical, Inc.
- Decided: Jun 28, 2011 after 218 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) The Tantalum Bead Set: named in the summary without a submission number

## 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/K103417
Methodology: https://510kreport.com/methodology