510(k) · Cleared
ClearedMedpor Ocular Peg System and Accessories
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Porex Technologies Corp. of Georgia · HPZ Implant, Eye Sphere
Cleared on May 29, 1996 after an 89-day review. The FDA summary names its predicate without a number. 2 later devices descend from it.
- Decided
- May 29, 1996
- Review
- 89 days
- Class
- Class II
- Product code
- HPZ
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 2 citing it directly.
- This deviceK960859 Medpor Ocular Peg System and AccessoriesPorex Technologies Corp. of Georgia · 1996
- Descendant · cites it directly · 0 of its ownK040851 Medpor Attractor Magnetic Coupling SystemPorex Surgical, Inc. · 2004
- Descendant · cites it directly · 0 of its ownK974203 Perry-Kolberg (PK) Titanium Motility/Support SystemIntegrated Orbital Implants, Inc. · 1998 · Recalled
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K960859 | Medpor Ocular Peg System and Accessories | Porex Technologies Corp. of Georgia | 1996 | — |
| +1 | K040851 | Medpor Attractor Magnetic Coupling System | Porex Surgical, Inc. | 2004 | — |
| +1 | K974203 | Perry-Kolberg (PK) Titanium Motility/Support System | Integrated Orbital Implants, Inc. | 1998 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2004 | 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? (2)
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 |
|---|---|---|---|
| * | — | The ocular pegging system offered in conjunction with the porous hydroxyapatite sphere… Named without a submission number | |
| * | — | MEDPOR® Ocular Screw and Accessories Named without a submission number |
What descends from it? (2)
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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K040851 (Porex Surgical, Inc., 2004) has gone furthest, with 0 descendants 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 | — |
https://510kreport.com/device/K960859 · printed Nov 4, 2026
Cite this page
510(k) Report. “K960859: Medpor Ocular Peg System and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K960859
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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