# HPZ: Implant, Eye Sphere

- Device class: 2; regulation: 21 CFR 886.3320; FDA's rule: 510(k) required
- FDA decisions: 39
- 510(k) review time 2021–2025: median 298 days (middle half 298–298)
- Recalls: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2002: 2
- 2003: 1
- 2004: 2
- 2006: 1
- 2007: 2
- 2008: 1
- 2009: 2
- 2011: 2
- 2013: 1
- 2022: 1

## Most-cited predicates
- K021357: Medpor Plus Orbital Volume Replacement Impant (2002), cited by 3
- K934834: Eptfe Sheet Covering for Ocular Implant (1994), cited by 3
- K972661: Eye Sphere, Conformers (1997), cited by 2
- K960859: Medpor Ocular Peg System and Accessories (1996), cited by 2
- K070130: Orbital Reconstructive Implant (2007), cited by 1
- K010902: Medpor Quad Motility Implant (2001), cited by 1
- K921106: Sterile/Single Use Eye Sphere Implants (1992), cited by 1
- K891137: Motility Orbital Implant (1989), cited by 1
- K954939: Medpor Ocular Screw & Accessories (1996), cited by 1
- K003338: Bio-Eye II Orbital Implant (2001), cited by 1

Source page: https://510kreport.com/product-code/HPZ
Data by year (CSV): https://510kreport.com/product-code/HPZ.csv