510(k) · Cleared
ClearedAlphasphere Orbital Implant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hydron Pty Limited · HPZ Implant, Eye Sphere
Cleared on May 9, 2006 as substantially equivalent to K010902 (Porex Surgical, Inc., 2001) and 2 other predicates after a 165-day review. Its family tree reaches back 1 generation to 2001.
- Decided
- May 9, 2006
- Review
- 165 days
- Class
- Class II
- Product code
- HPZ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K003338 (2001). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK003338 Bio-Eye II Orbital ImplantIntegrated Orbital Implants, Inc. · 2001 · Recalled
- This deviceK053298 Alphasphere Orbital ImplantHydron Pty Limited · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K003338 | Bio-Eye II Orbital Implant | Integrated Orbital Implants, Inc. | 2001 | 1 |
| 0 (this device) | K053298 | Alphasphere Orbital Implant | Hydron Pty Limited | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 1 | 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 |
|---|---|---|---|
| * | K010902 | Medpor Quad Motility ImplantSummary page 1…UIVALENT To: The AlphaSphere Orbital Implant is substantially equivalent in intended use and mechanism of action to the Porex Surgical's Medporc9 Quad Motility Implant (K0 10902) and to Integrated Orbital Implants' Bio Eye II (K003338). The AlphaSphere is also substantially equivalent to the AlphaCor Artif… | 2001 |
| * | K003338 | Bio-Eye II Orbital ImplantSummary page 1…action to the Porex Surgical's NMedpor® Quad Motility Implant (KO 10902) and to Integrated Orbital Implants' Bio Eye II (K003338). The AlphaSphere is also substantially equivalent to the AiphaCor Artificial Cornea,… | 2001 |
| * | K013756 | Alphacor; Alphacor-a (for Ahakic Eyes); Alphacor-P (for Phakic or Pseudophakic Eyes)Summary page 1…ital Implants' Bio Eye II (K003338). The AlphaSphere is also substantially equivalent to the AiphaCor Artificial Cornea, (K013756) in material formulation and mechanism of action for device integration. SUBSTANTIALLY EQUIVALENT To:… | 2002 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- 1 of the 3 ancestors has a recall of any class.
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?
The AlphaSphere Orbital Implant is intended to replace orbital volume after loss of an eye through enucleation or evisceration, including secondary implantation after removal of an existing, unsatisfactory, orbital implant. The device is indicated in any situation where silicone, acrylic, polyethylene, coral, glass, or other traditional orbital implants are used.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053298 · printed Nov 6, 2026
Cite this page
510(k) Report. “K053298: Alphasphere Orbital Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053298
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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