# K921106: Sterile/Single Use Eye Sphere Implants

- Pathway: 510(k) (Traditional)
- Applicant: Storz Instrument Co.
- Decided: Mar 30, 1992 after 21 days
- Product code: HPZ (Implant, Eye Sphere)
- Device class: 2
- Regulation: 21 CFR 886.3320
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 1 cites it directly.
0 of 5 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
- K972661: Eye Sphere, Conformers (1997), 3 descendants of its own
- K070130: Orbital Reconstructive Implant (2007), 1 descendant of its own
- K083342: Orbital Reconstructive Implant II (2009), 0 descendants of its own
- K082850: Eye Spheres (2009), 0 descendants of its own

Source page: https://510kreport.com/device/K921106
Methodology: https://510kreport.com/methodology