# K912641: Biopro Ziralloy Modular Femoral Heads

- Pathway: 510(k) (Traditional)
- Applicant: Biopro, Inc.
- Decided: Nov 27, 1991 after 166 days
- Product code: LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3353
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K220336: Mg-PSZ Ceramic Femoral Head (2022), 0 descendants of its own

## Recalls of this device
- Sep 9, 2025 · Class II · Z-0151-2026: Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infection if device is implanted.

Source page: https://510kreport.com/device/K912641
Methodology: https://510kreport.com/methodology