510(k) · Cleared
Recalled · 2012Medpor Plus Orbital Volume Replacement Impant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Porex Surgical, Inc. · HPZ Implant, Eye Sphere
Cleared on Aug 5, 2002 after a 98-day review. The FDA summary names its predicate without a number. 3 later devices descend from it. It has been recalled once.
- Decided
- Aug 5, 2002
- Review
- 98 days
- Class
- Class II
- Product code
- HPZ
- Recalls
- 1
- Predicates
- 0
3 later devices descend from it, 3 citing it directly.
- This deviceK021357 Medpor Plus Orbital Volume Replacement ImpantPorex Surgical, Inc. · 2002
- Descendant · cites it directly · 1 of its ownK070130 Orbital Reconstructive ImplantBecker & Associates Consulting, Inc. · 2007
- Descendant · cites it directly · 0 of its ownK212741 EzyporFci (France Chirurgie Instrumentation) Sas · 2022
- Descendant · cites it directly · 0 of its ownK083342 Orbital Reconstructive Implant IIEvera Medical, Inc. · 2009
Most influential descendants
Showing 3 of 3 · See all- K070130Orbital Reconstructive ImplantBecker & Associates Consulting, Inc. · 2007 · cites it directly1descendant
- K212741EzyporFci (France Chirurgie Instrumentation) Sas · 2022 · cites it directly0descendants
- K083342Orbital Reconstructive Implant IIEvera Medical, Inc. · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K021357 | Medpor Plus Orbital Volume Replacement Impant | Porex Surgical, Inc. | 2002 | — |
| +1 | K070130 | Orbital Reconstructive Implant | Becker & Associates Consulting, Inc. | 2007 | — |
| +1 | K212741 | Ezypor | Fci (France Chirurgie Instrumentation) Sas | 2022 | — |
| +1 | K083342 | Orbital Reconstructive Implant II | Evera Medical, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2022 | 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 |
|---|---|---|---|
| * | — | Orbital volume replacement implants currently cleared for marketing Named without a submission number | |
| * | — | Bioglass Synthetic Bone Graft Particulate Named without a submission number |
What descends from it? (3)
3 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 |
|---|---|---|---|---|
| Mar 20, 2012 | Not classified | Z-1435-2012 | Process control | The MEDPOR PLUS SST EZ 22mm sphere implants are not within specification of 22mm +/- 8, therefore implant is not easily released from the syringe. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- 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?
MEDPOR Surgical Implants in block, sheet and preformed shapes are intended for augmentation or restoration in the craniofacial region.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021357 · printed Nov 4, 2026
Cite this page
510(k) Report. “K021357: Medpor Plus Orbital Volume Replacement Impant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021357
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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