510(k) · Cleared
Recalled · 2002Eye Sphere, Conformers
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gulden Ophthalmics · HPZ Implant, Eye Sphere
Cleared on Oct 3, 1997 as substantially equivalent to K921106 (Storz Instrument Co., 1992) after a 79-day review. Its family tree reaches back 1 generation to 1992. 3 later devices descend from it. It has been recalled 13 times.
- Decided
- Oct 3, 1997
- Review
- 79 days
- Class
- Class II
- Product code
- HPZ
- Recalls
- 13
- Predicates
- 1
Its longest line of descent runs back 1 generation to K921106 (1992). 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK921106 Sterile/Single Use Eye Sphere ImplantsStorz Instrument Co. · 1992
- This deviceK972661 Eye Sphere, ConformersGulden Ophthalmics · 1997
- Descendant · cites it directly · 1 of its ownK070130 Orbital Reconstructive ImplantBecker & Associates Consulting, Inc. · 2007
- Descendant · 2 generations on · 0 of its ownK083342 Orbital Reconstructive Implant IIEvera Medical, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK082850 Eye SpheresProduct and Educational Services, LLC · 2009
Most influential descendants
Showing 3 of 3 · See all- K070130Orbital Reconstructive ImplantBecker & Associates Consulting, Inc. · 2007 · cites it directly1descendant
- K083342Orbital Reconstructive Implant IIEvera Medical, Inc. · 2009 · 2 generations on0descendants
- K082850Eye SpheresProduct and Educational Services, LLC · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K921106 | Sterile/Single Use Eye Sphere Implants | Storz Instrument Co. | 1992 | — |
| 0 (this device) | K972661 | Eye Sphere, Conformers | Gulden Ophthalmics | 1997 | — |
| +1 | K070130 | Orbital Reconstructive Implant | Becker & Associates Consulting, Inc. | 2007 | — |
| +2 | K083342 | Orbital Reconstructive Implant II | Evera Medical, Inc. | 2009 | — |
| +1 | K082850 | Eye Spheres | Product and Educational Services, LLC | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HPZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new HPZ device
- #1 K212741 Ezyporscore 3.6 · 1 generation · no Class I recall
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K921106 | Sterile/Single Use Eye Sphere ImplantsSummary page 1…30 4: Predicate Device Identification: Eye Sphere — Non Sterile Gulden Ophthalmics, Elkins Park, PA Pre-amendment Eye Sphere — Sterile Storz Instruments, St. Louis, Mo K921106 Conformers — Non Sterile Gulden Ophthalmics, Elkins Park, PA Pre-amendment Conformers — Sterile Storz Instruments, St. Louis, Mo… | 1992 |
| * | — | Eye Sphere — Non Sterile Named without a submission number | |
| * | — | Conformers — Non Sterile Named without a submission number |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 29, 2002 | Not classified | Z-0528-03 | Other | lack of sterility assurance |
| Nov 29, 2002 | Not classified | Z-0529-03 | Other | lack of sterility assurance |
| Nov 29, 2002 | Not classified | Z-0531-03 | Other | lack of sterility assurance |
| Nov 29, 2002 | Not classified | Z-0534-03 | Other | lack of sterility assurance |
| Nov 29, 2002 | Not classified | Z-0535-03 | Other | lack of sterility assurance |
| Nov 29, 2002 | Not classified | Z-0536-03 | Other | lack of sterility assurance |
| Nov 29, 2002 | Not classified | Z-0537-03 | Other | lack of sterility assurance |
| Nov 29, 2002 | Not classified | Z-0530-03 | Other | lack of sterility assurance |
| Nov 29, 2002 | Not classified | Z-0539-03 | Other | lack of sterility assurance |
| Nov 29, 2002 | Not classified | Z-0540-03 | Other | lack of sterility assurance |
| Nov 29, 2002 | Not classified | Z-0532-03 | Other | lack of sterility assurance |
| Nov 29, 2002 | Not classified | Z-0533-03 | Other | lack of sterility assurance |
| Nov 29, 2002 | Not classified | Z-0538-03 | Other | lack of sterility assurance |
The 5 latest of 13 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K070130 (Becker & Associates Consulting, Inc., 2007) has gone furthest, with 1 descendant of its own.
How does its category compare?
All HPZ devicesHPZ Implant, Eye Sphere: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HPZ
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · HPZ
Too few HPZ 510(k)s in any year since 2007 to give a median.
Recalls per year · HPZ
1in 2012
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HPZ
6in 2011
MAUDE reports naming product code HPZ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 5 |
| 2008 | 1 | — | 0 | 7 |
| 2009 | 2 | — | 0 | 5 |
| 2010 | 0 | — | 1 | 3 |
| 2011 | 2 | — | 0 | 6 |
| 2012 | 0 | — | 1 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Eye Spheres: Eye spheres are permanent implants that occupy the eye cavity when it has become necessary to surgically remove the eye (enucleation) or the contents of the eye sac (evisceration).
Conformers: Conformers are temporary devices which maintain the shape of the eye and prevent closure or adhesion during the healing process.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K972661 · printed Nov 4, 2026
Cite this page
510(k) Report. “K972661: Eye Sphere, Conformers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K972661
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026