510(k) · Cleared
ClearedMedpor Plus Surgical Implant Biomaterial
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Porex Surgical, Inc. · FWP Prosthesis, Chin, Internal
Cleared on Mar 14, 2002 after a 232-day review. The FDA summary names its predicate without a number. 2 of the 45 devices in its family, counting itself, have a Class I recall. 44 later devices descend from it.
- Decided
- Mar 14, 2002
- Review
- 232 days
- Class
- Class II
- Product code
- FWP
- Recalls
- None
- Predicates
- 0
44 later devices descend from it, 1 citing it directly. 2 of the 45 devices in this family, counting this one, have a Class I recall.
- This deviceK012350 Medpor Plus Surgical Implant BiomaterialPorex Surgical, Inc. · 2002
- Descendant · cites it directly · 43 of its ownK043133 Aoc Porous Polyethylene, Aoc Porous Hdpe, Aoc Porous Polyethylene…Ceremed, Inc. · 2005
- Descendant · 2 generations on · 38 of its ownK062280 Ostene, Aoc, Osteotene, Ceretene, Cerepor, Aptene, Apatene and…Ceremed, Inc. · 2006
- Descendant · 3 generations on · 29 of its ownK070093 Ostene, Aoc, Osteotene, Ceretene, Cerepor, Aptene, Apatene, ActipasteCeremed, Inc. · 2007
- Descendant · 4 generations on · 28 of its ownK082491 Ostene CT Soluble Bone Hemostasis Implant Material, Aoc CT, Aoc…Ceremed, Inc. · 2008
- Descendant · 5 generations on · 20 of its ownK091636 Ostene CT, Aoc CT, Osteotene, CereteneCeremed, Inc. · 2009
Showing 5 of 44 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 44 · See all- K043133Aoc Porous Polyethylene, Aoc Porous Hdpe, Aoc Porous Polyethylene Surgical Implant…Ceremed, Inc. · 2005 · cites it directly43descendants
- K062280Ostene, Aoc, Osteotene, Ceretene, Cerepor, Aptene, Apatene and ActipasteCeremed, Inc. · 2006 · 2 generations on38descendants
- K070093Ostene, Aoc, Osteotene, Ceretene, Cerepor, Aptene, Apatene, ActipasteCeremed, Inc. · 2007 · 3 generations on29descendants
- K082491Ostene CT Soluble Bone Hemostasis Implant Material, Aoc CT, Aoc, Ostene, Osteotene &…Ceremed, Inc. · 2008 · 4 generations on28descendants
- K091636Ostene CT, Aoc CT, Osteotene, CereteneCeremed, Inc. · 2009 · 5 generations on20descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K012350 | Medpor Plus Surgical Implant Biomaterial | Porex Surgical, Inc. | 2002 | — |
| +1 | K043133 | Aoc Porous Polyethylene, Aoc Porous Hdpe, Aoc Porous Polyethylene Surgical… | Ceremed, Inc. | 2005 | — |
| +2 | K062280 | Ostene, Aoc, Osteotene, Ceretene, Cerepor, Aptene, Apatene and Actipaste | Ceremed, Inc. | 2006 | — |
| +3 | K070093 | Ostene, Aoc, Osteotene, Ceretene, Cerepor, Aptene, Apatene, Actipaste | Ceremed, Inc. | 2007 | — |
| +4 | K082491 | Ostene CT Soluble Bone Hemostasis Implant Material, Aoc CT, Aoc, Ostene… | Ceremed, Inc. | 2008 | — |
| +5 | K091636 | Ostene CT, Aoc CT, Osteotene, Ceretene | Ceremed, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 4 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 6 | 2 |
| 2012 | 4 | 0 |
| 2013 | 3 | 0 |
| 2014 | 5 | 0 |
| 2015 | 2 | 0 |
| 2016 | 3 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 4 | 0 |
| 2024 | 2 | 0 |
| 2026 | 2 | 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.
2 devices in this family have a Class I recall. 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 FWP device
- #1 K254233 MEDPOR Customized Implant Kitscore 13.1 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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 |
|---|---|---|---|
| * | — | MEDPOR® Surgical Implant Material Named without a submission number | |
| * | — | Bioglass® Synthetic Bone Graft Particulate Named without a submission number |
What descends from it? (44)
See all 441 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K043133 | Aoc Porous Polyethylene, Aoc Porous Hdpe, Aoc Porous Polyethylene Surgical Implant… | 2005 | 43 |
Has anything in its family been recalled? (2 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K103822Synthes Hemostatic Bone Putty (HBP)Synthes USA Products, LLC · 2011 · 5 generations on · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
- K113079Synthes Hemostatic Bone PuttySynthes (Usa) Products, LLC/Norian Corporation · 2011 · 5 generations on · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K043133 (Ceremed, Inc., 2005) has gone furthest, with 43 descendants of its own.
How does its category compare?
All FWP devicesFWP Prosthesis, Chin, Internal: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FWP
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · FWP
Too few FWP 510(k)s in any year since 2007 to give a median.
Recalls per year · FWP
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FWP
17in 2025
MAUDE reports naming product code FWP, 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 | 3 |
| 2008 | 0 | — | 0 | 3 |
| 2009 | 1 | — | 0 | 5 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 22 |
| 2012 | 1 | — | 0 | 6 |
| 2013 | 0 | — | 0 | 9 |
| 2014 | 1 | — | 0 | 5 |
| 2015 | 1 | — | 0 | 8 |
| 2016 | 2 | — | 0 | 6 |
| 2017 | 0 | — | 0 | 13 |
| 2018 | 0 | — | 0 | 7 |
| 2019 | 2 | — | 0 | 15 |
| 2020 | 1 | — | 0 | 6 |
| 2021 | 0 | — | 0 | 13 |
| 2022 | 0 | — | 0 | 12 |
| 2023 | 1 | — | 0 | 6 |
| 2024 | 0 | — | 0 | 10 |
| 2025 | 0 | — | 1 | 17 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
MEDPOR® Plus Surgical Implants in block, sheet and preformed shapes are intended for the augmentation or restoration of contour in craniofacial applications.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K012350 · printed Nov 5, 2026
Cite this page
510(k) Report. “K012350: Medpor Plus Surgical Implant Biomaterial.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K012350
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026