510(k) · Cleared
ClearedOrbital Reconstructive Implant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Becker & Associates Consulting, Inc. · HPZ Implant, Eye Sphere
Cleared on Apr 19, 2007 as substantially equivalent to K021357 (Porex Surgical, Inc., 2002) and 3 other predicates after a 93-day review. Its family tree reaches back 2 generations to 1992. 1 later device descends from it.
- Decided
- Apr 19, 2007
- Review
- 93 days
- Class
- Class II
- Product code
- HPZ
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K921106 (1992). 6 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK921106 Sterile/Single Use Eye Sphere ImplantsStorz Instrument Co. · 1992
- 1 generation backK972661 Eye Sphere, ConformersGulden Ophthalmics · 1997 · Recalled
- This deviceK070130 Orbital Reconstructive ImplantBecker & Associates Consulting, Inc. · 2007
- Descendant · cites it directly · 0 of its ownK083342 Orbital Reconstructive Implant IIEvera Medical, Inc. · 2009
Most influential descendants
Showing 1 of 1 · See all- 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 |
|---|---|---|---|---|---|
| −2 | K921106 | Sterile/Single Use Eye Sphere Implants | Storz Instrument Co. | 1992 | — |
| −1 | K972661 | Eye Sphere, Conformers | Gulden Ophthalmics | 1997 | 13 |
| 0 (this device) | K070130 | Orbital Reconstructive Implant | Becker & Associates Consulting, Inc. | 2007 | — |
| +1 | K083342 | Orbital Reconstructive Implant II | Evera Medical, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 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? (4)
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 1…Predicate Device(s): Trade Name: Medpor Plus Orbital Volume Replacement Implant Manufacturer: Porex Surgical, Inc. K Number: K021357 Product Code: HPZ Trade Name: Eye Sphere Conformer Manufacturer: Gulden Ophthalmics… | 2002 |
| * | K972661 | Eye Sphere, ConformersSummary page 1…er: K021357 Product Code: HPZ Trade Name: Eye Sphere Conformer Manufacturer: Gulden Ophthalmics K Number: K972661 Product Code: HPZ / HQN… | 1997 |
| * | K060151 | Orbital Tissue Expander (Ote)Summary page 2…SULTING Orbital Reconstructive Implant Trade Name: Orbital Tissue Expander Manufacturer: Innovia LLC K Number: K060151 Product Code: NFM Trade Name: Oculo-Plastik Universal-ePTFE Manufacturer: O… | 2006 |
| * | K934834 | Eptfe Sheet Covering for Ocular ImplantSummary page 2…oduct Code: NFM Trade Name: Oculo-Plastik Universal-ePTFE Manufacturer: Oculo-Plastik, Inc. K Number: K934834 Product Code: HPZ Device Description: The ORI is a non-absorbable, inert, sterile, porous, surgical… | 1994 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K083342 | Orbital Reconstructive Implant II | 2009 | 0 |
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 15 years and passes through 3 companies; a new generation was cleared every 9.5 years on median.
- 2 of the 6 ancestors have a recall of any class.
- Of its descendants, K083342 (Evera Medical, Inc., 2009) has gone furthest, with 0 descendants of its own.
- 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. 2007, 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 Orbital Reconstructive Implant is indicated as an implant for augmentation, reconstruction, or restoration in and around the orbit of the eye, such as in reconstruction following orbital trauma or tumor excision, to treat orbital volume deficiencies, or in the correction of enophthalmos. The ORI is also indicated as a temporary device to maintain the shape of the eye and prevent closure or adhesion during the postoperative period.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070130 · printed Nov 4, 2026
Cite this page
510(k) Report. “K070130: Orbital Reconstructive Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K070130
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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