510(k) · Cleared
ClearedEzypor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fci (France Chirurgie Instrumentation) Sas · HPZ Implant, Eye Sphere
Cleared on Jun 24, 2022 as substantially equivalent to K021357 (Porex Surgical, Inc., 2002) after a 298-day review. Its family tree reaches back 1 generation to 2002.
- Decided
- Jun 24, 2022
- Review
- 298 days
- Class
- Class II
- Product code
- HPZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K021357 (2002). No later device cites it as a predicate yet.
- Root · 1 generation backK021357 Medpor Plus Orbital Volume Replacement ImpantPorex Surgical, Inc. · 2002 · Recalled
- This deviceK212741 EzyporFci (France Chirurgie Instrumentation) Sas · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K021357 | Medpor Plus Orbital Volume Replacement Impant | Porex Surgical, Inc. | 2002 | 1 |
| 0 (this device) | K212741 | Ezypor | Fci (France Chirurgie Instrumentation) Sas | 2022 | — |
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.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
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 |
|---|---|---|---|
| * | K021357 | Medpor Plus Orbital Volume Replacement ImpantSummary page 4…edicate Device EZYPOR® orbital implants are substantially equivalent to the MEDPOR® Plus SST™ Sphere (Smooth Surface Tunnel Sphere, 510(k) Premarket Notification Number K021357, FDA Product Code HPZ. Identification of a Legally Marketed Reference Device The MEDPOR® Sphere (K863943; Product Code HPZ) is… | 2002 |
| † | K863943 | Porex (TM) Eye Sphere Implant | 1987 |
| † | K911110 | Ophta Sil (R), Enulceation/Evisceration Implants | 1991 |
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?
- Its one ancestor has a recall.
- 2 other devices also cite its predicate K021357.
How does its category compare?
All HPZ devicesHPZ Implant, Eye Sphere: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
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 EZYPOR@ orbital implants are designed to fill the orbital cavity following enucleation, evisceration or during secondary implantation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K212741 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212741: Ezypor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212741
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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