510(k) · Cleared
ClearedOrbital Reconstructive Implant II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Evera Medical, Inc. · HPZ Implant, Eye Sphere
Cleared on Mar 12, 2009 as substantially equivalent to K070130 (Becker & Associates Consulting, Inc., 2007) and 3 other predicates after a 120-day review. Its family tree reaches back 3 generations to 1992.
- Decided
- Mar 12, 2009
- Review
- 120 days
- Class
- Class II
- Product code
- HPZ
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K921106 (1992). 9 ancestors in all, the oldest K780987 (1978). No later device cites it as a predicate yet.
- Root · 3 generations backK921106 Sterile/Single Use Eye Sphere ImplantsStorz Instrument Co. · 1992
- 2 generations backK972661 Eye Sphere, ConformersGulden Ophthalmics · 1997 · Recalled
- 1 generation backK070130 Orbital Reconstructive ImplantBecker & Associates Consulting, Inc. · 2007
- This deviceK083342 Orbital Reconstructive Implant IIEvera Medical, Inc. · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K921106 | Sterile/Single Use Eye Sphere Implants | Storz Instrument Co. | 1992 | — |
| −2 | K972661 | Eye Sphere, Conformers | Gulden Ophthalmics | 1997 | 13 |
| −1 | K070130 | Orbital Reconstructive Implant | Becker & Associates Consulting, Inc. | 2007 | — |
| 0 (this device) | K083342 | Orbital Reconstructive Implant II | Evera Medical, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2006 | 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 |
|---|---|---|---|
| * | K070130 | Orbital Reconstructive ImplantSummary page 1…Class II Predicate Device(s): Trade Name: Orbital Reconstructive Implant Manufacturer: Evera Medical, Inc. K Number. K070130 Product Code. HPZ Trade Name: Medpor Plus Orbital Volume Replacement Implant Manufacturer.… | 2007 |
| * | K021357 | Medpor Plus Orbital Volume Replacement ImpantSummary page 1…uct Code. HPZ Trade Name: Medpor Plus Orbital Volume Replacement Implant Manufacturer. Porex Surgical, Inc. K Number: K021357 Product Code: HPZ Trade Name. Oculo-Plastik Universal-ePTFE Manufacturer: Oculo-Plastik… | 2002 |
| * | K934834 | Eptfe Sheet Covering for Ocular ImplantSummary page 1…021357 Product Code: HPZ Trade Name. Oculo-Plastik Universal-ePTFE Manufacturer: Oculo-Plastik, Inc. K Number: K934834 Product Code: HPZ Trade Name: Solid Silicone and Silicone Foam Implants Manufacturer:… | 1994 |
| * | K950806 | Solid Dilicone Implants, Sdilicone Sponge ImplantsSummary page 2…834 Product Code: HPZ Trade Name: Solid Silicone and Silicone Foam Implants Manufacturer: MIRA, Inc. K Number: K950806 Product Code: HQX Device Description: The Orbital Reconstructive Implant II (ORI II) is a non-… | 1996 |
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 17 years and passes through 4 companies; a new generation was cleared every 5.5 years on median.
- 2 of the 9 ancestors have 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. 2009, 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 II 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083342 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083342: Orbital Reconstructive Implant II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083342
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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