# K011856: Radiographic Markers

- Pathway: 510(k) (Traditional)
- Applicant: Encore Orthopedics, Inc.
- Decided: Aug 22, 2001 after 70 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.
17 later devices descend from it; 1 cites it directly.
0 of 19 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.

## Most influential descendants
- K061066: Synergy Hip System (2006), 16 descendants of its own
- K111546: U2 Hip System (2011), 13 descendants of its own
- K122185: U-Motion II Acetabular System (2013), 7 descendants of its own
- K163441: Locking Cage, Full XPE Cup (2017), 3 descendants of its own
- K132455: U-Motion II PS+ Cup (2013), 3 descendants of its own

## Indications for use
The Radiographic Markers are intended for implantation in the bone to aid the surgeon in radiographic assessment of total hip or knee component movement. The Radiographic Markers are manufactured from inert, biocompatible materials.

Source page: https://510kreport.com/device/K011856
Methodology: https://510kreport.com/methodology