510(k) · Cleared
ClearedHA Orbital Implant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Laboratoire Villanova · HPZ Implant, Eye Sphere
Cleared on Dec 13, 2002 as substantially equivalent to K982562 (Integrated Orbital Implants, Inc., 1998) after a 207-day review. Its family tree reaches back 2 generations to 1986.
- Decided
- Dec 13, 2002
- Review
- 207 days
- Class
- Class II
- Product code
- HPZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K860983 (1986). 4 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K860983 | Interpore 200 Porous Hydroxyapatite | Interpore Intl. | 1986 | — |
| −1 | K982562 | Bio-Eye Hydroxyapatite Ocular Impland and Conformer | Integrated Orbital Implants, Inc. | 1998 | 2 |
| 0 (this device) | K021643 | HA Orbital Implant | Laboratoire Villanova | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1995 | 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? (1)
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 |
|---|---|---|---|
| * | K982562 | Bio-Eye Hydroxyapatite Ocular Impland and ConformerSummary page 1…Bio-Eye@hyd roxya pat ite ocular impla nt Integrated Orbital Implant lnc 510(k) ~ \ I K 982562 Common Name Orbital Implant Classification Name Eve Sphere Implant Class… | 1998 |
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?
- The line of descent spans 16 years and passes through 3 companies; a new generation was cleared every 12.6 years on median.
- 1 of the 4 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?
HA ORBITAL IMPLANTS are intra-orbital synthetic hydroxyapatite (Calo(PO₄) (OH)₂) implants designed to fill in the orbital cavity following enucleation, evisceration or during secondary implantation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021643 · printed Nov 4, 2026
Cite this page
510(k) Report. “K021643: HA Orbital Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021643
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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