Product Code: HPZ
FDA class 2
21 CFR 886.3320
Implant, Eye Sphere
Ophthalmic
An Eye Sphere Implant is a surgically implanted orbital prosthesis placed within the eye socket following enucleation or evisceration to restore orbital volume, support ocular motility of a prosthetic eye, and maintain normal socket anatomy. This device is FDA Class 2 (moderate risk), requiring premarket notification (510(k)) before marketing. It carries product code HPZ and is regulated under 21 CFR 886.3320, within the Ophthalmic medical specialty. It is classified as an implant.
510(k)s
39
FEI Numbers
17
Registration Numbers
17
Unique Applicants
24
Years Active
44
Basic Information
- Product Code
- HPZ
- Device Class
- FDA class 2
- Regulation Number
- 886.3320
- Medical Specialty
- Ophthalmic
- Review Panel
- OP
- Submission Type
- 1
Device Characteristics
✗
GMP Exempt
✓
Implant
✗
Life Sustain/Support
✗
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 39 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K212741 | EZYPOR | Jun 24, 2022 | Substantially Equivalent | FCI (France Chirurgie Instrumentation) SAS |
| K123764 | DURETTE OCULAR IMPLANT | Jan 31, 2013 | Substantially Equivalent | OCULO-PLASTIK, INC. |
| K110554 | BIOCERAMIC ORBITAL IMPLANT, ORBTEX | Nov 02, 2011 | Substantially Equivalent | CERAMISYS LTD. |
| K112176 | SILICONE SPHERES | Sep 15, 2011 | Substantially Equivalent | OCULO PLASTIK, INC. |
| K083342 | ORBITAL RECONSTRUCTIVE IMPLANT II | Mar 12, 2009 | Substantially Equivalent | EVERA MEDICAL, INC. |
| K082850 | EYE SPHERES | Feb 27, 2009 | Substantially Equivalent | PRODUCT AND EDUCATIONAL SERVICES LLC |
| K073293 | DURETTE IMPLANT | Mar 19, 2008 | Substantially Equivalent | OCULO PLASTIK, INC. |
| K071335 | MEDPOR ATTRACTOR IMPLANT | Aug 08, 2007 | Substantially Equivalent | POREX SURGICAL, INC. |
| K070130 | ORBITAL RECONSTRUCTIVE IMPLANT | Apr 19, 2007 | Substantially Equivalent | BECKER & ASSOCIATES CONSULTING INC |
| K053298 | ALPHASPHERE ORBITAL IMPLANT | May 09, 2006 | Substantially Equivalent | HYDRON PTY LIMITED |
| K040851 | MEDPOR ATTRACTOR MAGNETIC COUPLING SYSTEM | Jul 16, 2004 | Substantially Equivalent | POREX SURGICAL, INC. |
| K040689 | EYE SPHERE IMPLANTS | Jun 10, 2004 | Substantially Equivalent | OCULO PLASTIK, INC. |
| K023400 | FCI MESH WRAPPED BIOCERAMIC ORBITAL IMPLANT | Aug 22, 2003 | Substantially Equivalent | FCI OPHTHALMICS, INC. |
| K021643 | HA ORBITAL IMPLANT | Dec 13, 2002 | Substantially Equivalent | LABORATOIRE VILLANOVA |
| K021357 | MEDPOR PLUS ORBITAL VOLUME REPLACEMENT IMPANT | Aug 05, 2002 | Substantially Equivalent | POREX SURGICAL, INC. |
| K010902 | MEDPOR QUAD MOTILITY IMPLANT | Jun 19, 2001 | Substantially Equivalent | POREX SURGICAL, INC. |
| K003338 | BIO-EYE II ORBITAL IMPLANT | Feb 07, 2001 | Substantially Equivalent | INTEGRATED ORBITAL IMPLANTS, INC. |
| K992294 | BIOCERAMIC ORBITAL IMPLANT | Apr 19, 2000 | Substantially Equivalent | FCI OPHTHALMICS, INC. |
| K982562 | BIO-EYE HYDROXYAPATITE OCULAR IMPLAND AND CONFORMER | Dec 28, 1998 | Substantially Equivalent | INTEGRATED ORBITAL IMPLANTS, INC. |
| K972143 | MOA BONE / M-SPHERE | Oct 16, 1997 | Substantially Equivalent | IOP, INC. |
| K972661 | EYE SPHERE, CONFORMERS | Oct 03, 1997 | Substantially Equivalent | GULDEN OPHTHALMICS |
| K962241 | GORE SPHEREX IMPLANT | Aug 22, 1996 | Substantially Equivalent | W.L. GORE & ASSOCIATES,INC |
| K960859 | MEDPOR OCULAR PEG SYSTEM AND ACCESSORIES | May 29, 1996 | Substantially Equivalent | POREX TECHNOLOGIES CORP. OF GEORGIA |
| K954939 | MEDPOR OCULAR SCREW & ACCESSORIES | Jan 25, 1996 | Substantially Equivalent | POREX SURGICAL, INC. |
| K941717 | MARTINEZ HYDROXYLAPATITE ORBITAL IMPLANT | Feb 14, 1995 | Substantially Equivalent | MIGUEL MARTINEZ M.D. |
| K943275 | MEDPOR SURGICAL IMPLANT MATERIAL | Sep 02, 1994 | Substantially Equivalent | POREX SURGICAL, INC. |
| K934834 | EPTFE SHEET COVERING FOR OCULAR IMPLANT | May 05, 1994 | Substantially Equivalent | OCULO PLASTIK, INC. |
| K935251 | MARTINEZ ORBITAL IMPLANT | Mar 01, 1994 | Substantially Equivalent | MIGUEL MARTINEZ M.D. |
| K921106 | STERILE/SINGLE USE EYE SPHERE IMPLANTS | Mar 30, 1992 | Substantially Equivalent | STORZ INSTRUMENT CO. |
| K915630 | OPHTIMPLANT | Mar 02, 1992 | Substantially Equivalent | OCULO PLASTIK, INC. |
| K911110 | OPHTA SIL(R), ENULCEATION/EVISCERATION IMPLANTS | Jun 18, 1991 | Substantially Equivalent | G.W.B. INTL., LTD. |
| K900081 | NEW ALLEN IMPLANT | Mar 23, 1990 | Substantially Equivalent | OCULO PLASTIK, INC. |
| K900080 | NEW IOWA MOTILITY IMPLANT | Mar 23, 1990 | Substantially Equivalent | OCULO PLASTIK, INC. |
| K895908 | MULES SPHERE GLASS (SEVERAL SIZES) | Jan 08, 1990 | Substantially Equivalent | GINSBERG SCIENTIFIC, INC. |
| K891137 | MOTILITY ORBITAL IMPLANT | Aug 24, 1989 | Substantially Equivalent | INTEGRATED ORBITAL IMPLANTS, INC. |
| K873578 | LEE ALLEN'S UNIVERSAL MOTILITY IMPLANT | Nov 02, 1987 | Substantially Equivalent | OCULO-PLASTIK REG'D |
| K863943 | POREX(TM) EYE SPHERE IMPLANT | Feb 27, 1987 | Substantially Equivalent | POREX MEDICAL |
| K862977 | MEDITRADE ARTIFICIAL EYES AND IMPLANTS | Oct 20, 1986 | Substantially Equivalent | MEDITRADE, INC. |
| K781356 | IMPLANT, EYE SPHERE | Aug 21, 1978 | Substantially Equivalent | MCGHAN MEDICAL CORP. |
FEI Numbers
This FDA classification entry is associated with 17 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 17 registration numbers. Click on an entry to view related FDA registrations.