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/submissions/OP/subpart-d%E2%80%94prosthetic-devices/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](https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/HPZ/K212741.md) | EZYPOR | Fci (France Chirurgie Instrumentation) Sas | Jun 24, 2022 | SESE | | [K123764](https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/HPZ/K123764.md) | DURETTE OCULAR IMPLANT | Oculo-Plastik, Inc. | Jan 31, 2013 | SESE | | [K110554](https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/HPZ/K110554.md) | BIOCERAMIC ORBITAL IMPLANT, ORBTEX | Ceramisys, Ltd. | Nov 2, 2011 | SESE | | [K112176](https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/HPZ/K112176.md) | SILICONE SPHERES | Oculo Plastik, Inc. | Sep 15, 2011 | SESE | | [K083342](https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/HPZ/K083342.md) | ORBITAL RECONSTRUCTIVE IMPLANT II | Evera Medical, Inc. | Mar 12, 2009 | SESE | | [K082850](https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/HPZ/K082850.md) | EYE SPHERES | Product and Educational Services, LLC | Feb 27, 2009 | SESE | | [K073293](https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/HPZ/K073293.md) | DURETTE IMPLANT | Oculo Plastik, Inc. | Mar 19, 2008 | SESE | | [K071335](https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/HPZ/K071335.md) | MEDPOR ATTRACTOR IMPLANT | Porex Surgical, Inc. | Aug 8, 2007 | SESE | | [K070130](https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/HPZ/K070130.md) | ORBITAL RECONSTRUCTIVE IMPLANT | Becker & Associates Consulting, Inc. | Apr 19, 2007 | SESE | | [K053298](https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/HPZ/K053298.md) | ALPHASPHERE ORBITAL IMPLANT | Hydron Pty Limited | May 9, 2006 | SESE | | [K040851](https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/HPZ/K040851.md) | MEDPOR ATTRACTOR MAGNETIC COUPLING SYSTEM | Porex Surgical, Inc. | Jul 16, 2004 | SESE | | [K040689](https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/HPZ/K040689.md) | EYE SPHERE IMPLANTS | Oculo Plastik, Inc. | Jun 10, 2004 | SESE | | [K023400](https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/HPZ/K023400.md) | FCI MESH WRAPPED BIOCERAMIC ORBITAL IMPLANT | Fci Ophthalmics, Inc. | Aug 22, 2003 | SESE | | [K021643](https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/HPZ/K021643.md) | HA ORBITAL IMPLANT | Laboratoire Villanova | Dec 13, 2002 | SESE | | [K021357](https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/HPZ/K021357.md) | MEDPOR PLUS ORBITAL VOLUME REPLACEMENT IMPANT | Porex Surgical, Inc. | Aug 5, 2002 | SESE | | [K010902](https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/HPZ/K010902.md) | MEDPOR QUAD MOTILITY IMPLANT | Porex Surgical, Inc. | Jun 19, 2001 | SESE | | [K003338](https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/HPZ/K003338.md) | BIO-EYE II ORBITAL IMPLANT | Integrated Orbital Implants, Inc. | Feb 7, 2001 | SESE | | [K992294](https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/HPZ/K992294.md) | BIOCERAMIC ORBITAL IMPLANT | Fci Ophthalmics, Inc. | Apr 19, 2000 | SESE | | [K982562](https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/HPZ/K982562.md) | BIO-EYE HYDROXYAPATITE OCULAR IMPLAND AND CONFORMER | Integrated Orbital Implants, Inc. | Dec 28, 1998 | SESE | | [K972143](https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/HPZ/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 --- **Source:** [https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/HPZ](https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/HPZ) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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