PMA · Approved
ApprovedPro Osteon Implant 500 Hydroxyapatite Bone Void Filler
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Interpore Intl. · OIS Calcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation
Approved on Oct 29, 1992 through premarket approval, which rests on the device’s own clinical evidence after a 2,453-day review. 1 later device descends from it.
- Decided
- Oct 29, 1992
- Review
- 2,453 days
- Class
- Class II
- Product code
- OIS
- Recalls
- None
1 later device descends from it, 1 citing it directly.
- This deviceP860005 Pro Osteon Implant 500 Hydroxyapatite Bone Void FillerInterpore Intl. · 1992
- Descendant · cites it directly · 0 of its ownK070897 Bonemedik, and Bonemedik-SMeta Biomed Co., Ltd. · 2007
Most influential descendants
Showing 1 of 1 · See all- K070897Bonemedik, and Bonemedik-SMeta Biomed Co., Ltd. · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | P860005 | Pro Osteon Implant 500 Hydroxyapatite Bone Void Filler | Interpore Intl. | 1992 | — |
| +1 | K070897 | Bonemedik, and Bonemedik-S | Meta Biomed Co., Ltd. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
Sources: FDA PMA database (decision fields and supplements), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in OIS? 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
Does it have a predicate?
PMA decisions do not claim a predicate device.
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 |
|---|---|---|---|
| K070897 | Bonemedik, and Bonemedik-S | 2007 | 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?
- Of its descendants, K070897 (Meta Biomed Co., Ltd., 2007) has gone furthest, with 0 descendants of its own.
How does its category compare?
All OIS devicesOIS Calcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · OIS
1in 2008
2026 to Oct 25, outlined.
Median 510(k) review, days · OIS
Too few OIS 510(k)s in any year since 2007 to give a median.
Recalls per year · OIS
1in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OIS
2in 2013
MAUDE reports naming product code OIS, 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 | 0 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 1 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/P860005 · printed Nov 6, 2026
Cite this page
510(k) Report. “P860005: Pro Osteon Implant 500 Hydroxyapatite Bone Void Filler.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P860005
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026