# K103497: Ceramic Femoral Head

- Pathway: 510(k) (Traditional)
- Applicant: United Orthopedic Corp.
- Decided: Mar 4, 2011 after 95 days
- Product code: MEH (Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate)
- Device class: 2
- Regulation: 21 CFR 888.3353
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
9 later devices descend from it; 3 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K112463: United 36MM Ceramic Femoral Head, Delta (2011), 8 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
- K172833: E-XPE Acetabular Components and U-Motion II Acetabular Cup (2018), 2 descendants of its own

Source page: https://510kreport.com/device/K103497
Methodology: https://510kreport.com/methodology