# K010348: Tantalum Beads - Radiographic Marker

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: May 3, 2001 after 87 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.
63 later devices descend from it; 7 cite it directly.
0 of 64 devices 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) UltraClip Tissue Marker: named in the summary without a submission number
- (no number) Micromark Clip: named in the summary without a submission number

## Most influential descendants
- K063422: Bioaggregate (2006), 38 descendants of its own
- K080917: Iroot SP (2008), 37 descendants of its own
- K011856: Radiographic Markers (2001), 17 descendants of its own
- K061066: Synergy Hip System (2006), 16 descendants of its own
- K111546: U2 Hip System (2011), 13 descendants of its own

## Indications for use
Tantalum beads are used as radiopaque 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. Implant surgery associated with the use of radiographic markers may include total joint replacement, soft tissue repair, and bone fixation.

Source page: https://510kreport.com/device/K010348
Methodology: https://510kreport.com/methodology