# K972661: Eye Sphere, Conformers

- Pathway: 510(k) (Traditional)
- Applicant: Gulden Ophthalmics
- Decided: Oct 3, 1997 after 79 days
- Product code: HPZ (Implant, Eye Sphere)
- Device class: 2
- Regulation: 21 CFR 886.3320
- Recalls of this device: 13 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K921106 (1992). 1 ancestor in all.
3 later devices descend from it; 2 cite 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)
- K921106: Sterile/Single Use Eye Sphere Implants, Storz Instrument Co. (1992) Summary page 1.
- (no number) Eye Sphere — Non Sterile: named in the summary without a submission number
- (no number) Conformers — Non Sterile: named in the summary without a submission number

## Most influential descendants
- 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

## Recalls of this device
- Nov 29, 2002 · Not classified · Z-0528-03: lack of sterility assurance
- Nov 29, 2002 · Not classified · Z-0529-03: lack of sterility assurance
- Nov 29, 2002 · Not classified · Z-0531-03: lack of sterility assurance
- Nov 29, 2002 · Not classified · Z-0534-03: lack of sterility assurance
- Nov 29, 2002 · Not classified · Z-0535-03: lack of sterility assurance
- Nov 29, 2002 · Not classified · Z-0536-03: lack of sterility assurance
- Nov 29, 2002 · Not classified · Z-0537-03: lack of sterility assurance
- Nov 29, 2002 · Not classified · Z-0530-03: lack of sterility assurance
- Nov 29, 2002 · Not classified · Z-0539-03: lack of sterility assurance
- Nov 29, 2002 · Not classified · Z-0540-03: lack of sterility assurance
- Nov 29, 2002 · Not classified · Z-0532-03: lack of sterility assurance
- Nov 29, 2002 · Not classified · Z-0533-03: lack of sterility assurance
- Nov 29, 2002 · Not classified · Z-0538-03: lack of sterility assurance

## Indications for use
Eye Spheres: Eye spheres are permanent implants that occupy the eye cavity when it has become necessary to surgically remove the eye (enucleation) or the contents of the eye sac (evisceration). Conformers: Conformers are temporary devices which maintain the shape of the eye and prevent closure or adhesion during the healing process.

Source page: https://510kreport.com/device/K972661
Methodology: https://510kreport.com/methodology