Browse hierarchy: [Ophthalmic (OP)](/submissions/OP) → [Subpart D — Prosthetic Devices](/submissions/OP/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 886.3340](/submissions/OP/subpart-d%E2%80%94prosthetic-devices/886.3340) → HQX — Implant, Orbital, Extra-Ocular

# HQX · Implant, Orbital, Extra-Ocular

_Ophthalmic · 21 CFR 886.3340 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/HQX

## Overview

- **Product Code:** HQX
- **Device Name:** Implant, Orbital, Extra-Ocular
- **Regulation:** [21 CFR 886.3340](/submissions/OP/subpart-d%E2%80%94prosthetic-devices/886.3340)
- **Device Class:** 2
- **Review Panel:** [Ophthalmic](/submissions/OP)
- **Implant:** yes

## Identification

An extraocular orbital implant is a nonabsorbable device intended to be implanted during scleral surgery for buckling or building up the floor of the eye, usually in conjunction with retinal reattachment. Injectable substances are excluded.

## Classification Rationale

Class II.

## Recent Cleared Devices (16 of 16)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K023481](https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/HQX/K023481.md) | MICROVISION SCLERAL BUCKLING COMPONENTS | Microvision, Inc. | Jan 8, 2003 | SESE |
| [K983581](https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/HQX/K983581.md) | OCU-GUARD AND OCU-GUARD SUPPLE | Bio-Vascular, Inc. | Nov 6, 1998 | SESE |
| [K980816](https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/HQX/K980816.md) | RETINAL DETACHMENT IMPLANTS, INCLUDING BANDS, STRIPS (RAILS) AND SPONGES | Fci Ophthalmics, Inc. | Sep 18, 1998 | SESE |
| [K963219](https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/HQX/K963219.md) | RETINAL DETACHMENT IMPLANTS; INCLUDING BANS, STRIPS, TIRES, SLEEVES, CORDS AND SPONGES | Fci Ophthalmics, Inc. | Oct 28, 1996 | SESE |
| [K950806](https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/HQX/K950806.md) | SOLID DILICONE IMPLANTS, SDILICONE SPONGE IMPLANTS | Mira, Inc. | Jun 5, 1996 | SESE |
| [K950599](https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/HQX/K950599.md) | STORS SCLERAL SPONGE II (LINCOFF DESIGN) | Storz Ophthalmics, Inc. | Mar 2, 1995 | SESE |
| [K945172](https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/HQX/K945172.md) | VISITEC SILICONE RETINAL IMPLANTS/EXPLANTS | Visitec Co. | Jan 17, 1995 | SESE |
| [K902308](https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/HQX/K902308.md) | TAMCENAN OCULAR EXPLANTS AND BANDS | Tamcenan Corp. | Jun 19, 1990 | SESE |
| [K901002](https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/HQX/K901002.md) | O'DONNELL, SOCKET RECONSTRUCTION PROSTHESES | Oculo Plastik, Inc. | May 22, 1990 | SESE |
| [K900929](https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/HQX/K900929.md) | PUTTERMAN-SCOTT, SOCKET RECONSTRUCTION BILATERAL | Oculo Plastik, Inc. | May 18, 1990 | SESE |
| [K900930](https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/HQX/K900930.md) | SPIVEY-ALLEN ORBITAL FLOOR IMPLANT | Oculo Plastik, Inc. | May 15, 1990 | SESE |
| [K900928](https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/HQX/K900928.md) | COX MALAR EMINENCE IMPLANTS | Oculo Plastik, Inc. | May 15, 1990 | SESE |
| [K900927](https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/HQX/K900927.md) | CODERE-DURETTE ORBITAL FLOOR IMPLANT | Oculo Plastik, Inc. | May 15, 1990 | SESE |
| [K863946](https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/HQX/K863946.md) | POREX(TM) EXTRA-OCULAR ORBITAL IMPLANT | Porex Medical | Feb 27, 1987 | SESE |
| [K832481](https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/HQX/K832481.md) | SCLERAL BUCKLING IMPLANTS DIF/TYPES | Storz Instrument Co. | Sep 20, 1983 | SESE |
| [K800140](https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/HQX/K800140.md) | SILASTIC SCLERAL SPONGE II W/CIRCLING BD | Dow Corning Corp. Healthcare Industries Materials | Mar 3, 1980 | SESE |

## Top Applicants

- Oculo Plastik, Inc. — 5 clearances
- Fci Ophthalmics, Inc. — 2 clearances
- Bio-Vascular, Inc. — 1 clearance
- Dow Corning Corp. Healthcare Industries Materials — 1 clearance
- Microvision, Inc. — 1 clearance

---

**Source:** [https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/HQX](https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/HQX)

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