Browse hierarchy: [Ophthalmic (OP)](/submissions/OP) → [Subpart D — Prosthetic Devices](/submissions/OP/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 886.3320](/submissions/OP/subpart-d%E2%80%94prosthetic-devices/886.3320) → HPZ — Implant, Eye Sphere

# HPZ · Implant, Eye Sphere

_Ophthalmic · 21 CFR 886.3320 · Class 2_

**Canonical URL:** https://fda.innolitics.com/productcode/HPZ

## Overview

- **Product Code:** HPZ
- **Device Name:** Implant, Eye Sphere
- **Regulation:** [21 CFR 886.3320](/submissions/OP/subpart-d%E2%80%94prosthetic-devices/886.3320)
- **Device Class:** 2
- **Review Panel:** [Ophthalmic](/submissions/OP)
- **Implant:** yes

## Identification

An eye sphere implant is a device intended to be implanted in the eyeball to occupy space following the removal of the contents of the eyeball with the sclera left intact.

## Classification Rationale

Class II (special controls). The device, when it is an ocular peg which is supplied sterile only, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.

## Special Controls

*Classification.* Class II (special controls). The device, when it is an ocular peg which is supplied sterile only, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.

## Recent Cleared Devices (20 of 39)

Showing 20 most recent of 39 cleared devices.

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K212741](/device/K212741.md) | EZYPOR | Fci (France Chirurgie Instrumentation) Sas | Jun 24, 2022 | SESE |
| [K123764](/device/K123764.md) | DURETTE OCULAR IMPLANT | Oculo-Plastik, Inc. | Jan 31, 2013 | SESE |
| [K110554](/device/K110554.md) | BIOCERAMIC ORBITAL IMPLANT, ORBTEX | Ceramisys, Ltd. | Nov 2, 2011 | SESE |
| [K112176](/device/K112176.md) | SILICONE SPHERES | Oculo Plastik, Inc. | Sep 15, 2011 | SESE |
| [K083342](/device/K083342.md) | ORBITAL RECONSTRUCTIVE IMPLANT II | Evera Medical, Inc. | Mar 12, 2009 | SESE |
| [K082850](/device/K082850.md) | EYE SPHERES | Product and Educational Services, LLC | Feb 27, 2009 | SESE |
| [K073293](/device/K073293.md) | DURETTE IMPLANT | Oculo Plastik, Inc. | Mar 19, 2008 | SESE |
| [K071335](/device/K071335.md) | MEDPOR ATTRACTOR IMPLANT | Porex Surgical, Inc. | Aug 8, 2007 | SESE |
| [K070130](/device/K070130.md) | ORBITAL RECONSTRUCTIVE IMPLANT | Becker & Associates Consulting, Inc. | Apr 19, 2007 | SESE |
| [K053298](/device/K053298.md) | ALPHASPHERE ORBITAL IMPLANT | Hydron Pty Limited | May 9, 2006 | SESE |
| [K040851](/device/K040851.md) | MEDPOR ATTRACTOR MAGNETIC COUPLING SYSTEM | Porex Surgical, Inc. | Jul 16, 2004 | SESE |
| [K040689](/device/K040689.md) | EYE SPHERE IMPLANTS | Oculo Plastik, Inc. | Jun 10, 2004 | SESE |
| [K023400](/device/K023400.md) | FCI MESH WRAPPED BIOCERAMIC ORBITAL IMPLANT | Fci Ophthalmics, Inc. | Aug 22, 2003 | SESE |
| [K021643](/device/K021643.md) | HA ORBITAL IMPLANT | Laboratoire Villanova | Dec 13, 2002 | SESE |
| [K021357](/device/K021357.md) | MEDPOR PLUS ORBITAL VOLUME REPLACEMENT IMPANT | Porex Surgical, Inc. | Aug 5, 2002 | SESE |
| [K010902](/device/K010902.md) | MEDPOR QUAD MOTILITY IMPLANT | Porex Surgical, Inc. | Jun 19, 2001 | SESE |
| [K003338](/device/K003338.md) | BIO-EYE II ORBITAL IMPLANT | Integrated Orbital Implants, Inc. | Feb 7, 2001 | SESE |
| [K992294](/device/K992294.md) | BIOCERAMIC ORBITAL IMPLANT | Fci Ophthalmics, Inc. | Apr 19, 2000 | SESE |
| [K982562](/device/K982562.md) | BIO-EYE HYDROXYAPATITE OCULAR IMPLAND AND CONFORMER | Integrated Orbital Implants, Inc. | Dec 28, 1998 | SESE |
| [K972143](/device/K972143.md) | MOA BONE / M-SPHERE | Iop, Inc. | Oct 16, 1997 | SESE |

## Top Applicants

- Oculo Plastik, Inc. — 7 clearances
- Porex Surgical, Inc. — 6 clearances
- Integrated Orbital Implants, Inc. — 3 clearances
- Fci Ophthalmics, Inc. — 2 clearances
- Miguel Martinez M.D. — 2 clearances

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**Source:** [https://fda.innolitics.com/productcode/HPZ](https://fda.innolitics.com/productcode/HPZ)

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