510(k) · Cleared
ClearedInterpore 200 Porous Hydroxyapatite
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Interpore Intl. · LYC Bone Grafting Material, Synthetic
Cleared on May 23, 1986 after a 67-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 11 later devices descend from it.
- Decided
- May 23, 1986
- Review
- 67 days
- Class
- Class II
- Product code
- LYC
- Recalls
- None
- Predicates
- 0
11 later devices descend from it, 4 citing it directly.
- This deviceK860983 Interpore 200 Porous HydroxyapatiteInterpore Intl. · 1986
- Descendant · cites it directly · 6 of its ownK042706 Ossatura DentalIsotis Orthobiologics, Inc. · 2004
- Descendant · 2 generations on · 2 of its ownK082419 Reoss Powder, Reoss Putty, Reoss Gel, Models R-1,RP-1, RG-1Intra-Lock International, Inc. · 2009
- Descendant · 3 generations on · 1 of its ownK101827 OsteoscafTexas Innovative Medical Devices (Dba) Skeletal · 2011
- Descendant · cites it directly · 1 of its ownK031813 Ossatura DentalIsotis NV · 2004
- Descendant · cites it directly · 1 of its ownK982562 Bio-Eye Hydroxyapatite Ocular Impland and ConformerIntegrated Orbital Implants, Inc. · 1998 · Recalled
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K042706Ossatura DentalIsotis Orthobiologics, Inc. · 2004 · cites it directly6descendants
- K082419Reoss Powder, Reoss Putty, Reoss Gel, Models R-1,RP-1, RG-1Intra-Lock International, Inc. · 2009 · 2 generations on2descendants
- K101827OsteoscafTexas Innovative Medical Devices (Dba) Skeletal · 2011 · 3 generations on1descendant
- K031813Ossatura DentalIsotis NV · 2004 · cites it directly1descendant
- K982562Bio-Eye Hydroxyapatite Ocular Impland and ConformerIntegrated Orbital Implants, Inc. · 1998 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K860983 | Interpore 200 Porous Hydroxyapatite | Interpore Intl. | 1986 | — |
| +1 | K042706 | Ossatura Dental | Isotis Orthobiologics, Inc. | 2004 | — |
| +2 | K082419 | Reoss Powder, Reoss Putty, Reoss Gel, Models R-1,RP-1, RG-1 | Intra-Lock International, Inc. | 2009 | — |
| +3 | K101827 | Osteoscaf | Texas Innovative Medical Devices (Dba) Skeletal | 2011 | — |
| +1 | K031813 | Ossatura Dental | Isotis NV | 2004 | — |
| +1 | K982562 | Bio-Eye Hydroxyapatite Ocular Impland and Conformer | Integrated Orbital Implants, Inc. | 1998 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 2 | 0 |
| 2007 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LYC? 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 LYC device
- #1 K253317 Cytrans™ Elashieldscore 14.3 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (11)
See all 114 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K042706 (Isotis Orthobiologics, Inc., 2004) has gone furthest, with 6 descendants of its own.
How does its category compare?
All LYC devicesLYC Bone Grafting Material, Synthetic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LYC
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LYC
267in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LYC
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LYC
2in 2025
MAUDE reports naming product code LYC, 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 | 13 | 80 | 0 | 23 |
| 2008 | 8 | 73 | 0 | 25 |
| 2009 | 14 | 100 | 1 | 25 |
| 2010 | 13 | 164 | 2 | 28 |
| 2011 | 9 | 224 | 0 | 21 |
| 2012 | 5 | 120 | 2 | 10 |
| 2013 | 2 | — | 0 | 12 |
| 2014 | 1 | — | 0 | 9 |
| 2015 | 0 | — | 0 | 14 |
| 2016 | 2 | — | 2 | 140 |
| 2017 | 0 | — | 0 | 19 |
| 2018 | 0 | — | 1 | 14 |
| 2019 | 0 | — | 0 | 15 |
| 2020 | 3 | 156 | 0 | 5 |
| 2021 | 0 | — | 0 | 12 |
| 2022 | 2 | — | 0 | 6 |
| 2023 | 0 | — | 0 | 9 |
| 2024 | 0 | — | 0 | 6 |
| 2025 | 3 | 267 | 0 | 2 |
| 2026 | 3 | 266 | 0 | — |
https://510kreport.com/device/K860983 · printed Nov 6, 2026
Cite this page
510(k) Report. “K860983: Interpore 200 Porous Hydroxyapatite.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K860983
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026