# K950806: Solid Dilicone Implants, Sdilicone Sponge Implants

- Pathway: 510(k) (Traditional)
- Applicant: Mira, Inc.
- Decided: Jun 5, 1996 after 469 days
- Product code: HQX (Implant, Orbital, Extra-Ocular)
- Device class: 2
- Regulation: 21 CFR 886.3340
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K780987 (1978). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K780987: Soft Silicone Elastomer Sponge Explant, Medical Instrument Research Assoc., Inc. (1978) Summary page 1.

## Most influential descendants
- K083342: Orbital Reconstructive Implant II (2009), 0 descendants of its own
- K023481: Microvision Scleral Buckling Components (2003), 0 descendants of its own

## Indications for use
These devices are used to "buckle” the sclera in retinal reattachment surgery.

Source page: https://510kreport.com/device/K950806
Methodology: https://510kreport.com/methodology