510(k) · Cleared
ClearedPorous Hdpe Surgical Implants, to BE Distributed Under Various Trademarks Including Epor, Biopor, Minopor & P-Hdpe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hohenstein Enterprises, Inc. · KKY Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
Cleared on Oct 9, 2002 as substantially equivalent to K922489 (Porex Technologies Corp., 1992) after a 61-day review. Its family tree reaches back 1 generation to 1992. 2 of the 48 devices in its family, counting itself, have a Class I recall. 46 later devices descend from it.
- Decided
- Oct 9, 2002
- Review
- 61 days
- Class
- Class II
- Product code
- KKY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K922489 (1992). 46 later devices descend from it, 3 citing it directly. 2 of the 48 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK922489 Medpor Surg Implant Material:Prefor Cran/Fac ImplaPorex Technologies Corp. · 1992 · Recalled
- This deviceK022665 Porous Hdpe Surgical Implants, to BE Distributed Under Various…Hohenstein Enterprises, 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 46 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 46 · 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 |
|---|---|---|---|---|---|
| −1 | K922489 | Medpor Surg Implant Material:Prefor Cran/Fac Impla | Porex Technologies Corp. | 1992 | 1 |
| 0 (this device) | K022665 | Porous Hdpe Surgical Implants, to BE Distributed Under Various Trademarks… | Hohenstein Enterprises, 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 | 2 | 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 | 2 | 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 KKY device
- #1 K211514 Longeviti PorousFit implantscore 2.0 · 2 generations · no Class I recall
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K922489 | Medpor Surg Implant Material:Prefor Cran/Fac ImplaSummary page 2…ANTIAL EQUIVALENCE ePor, Inc. Porous HDPE Surgical Implants are substantially equivalent to the MedporB Suraical Implant Material: Preformed Cranial and Facial Implants K922489, based on the subject devices’ similarity to the predicate devices in intended use, material, design, and surgical procedure. IN… | 1992 |
What descends from it? (46)
See all 463 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
How does its category compare?
All KKY devicesKKY Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KKY
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · KKY
224in 2014
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KKY
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KKY
1in 2025
MAUDE reports naming product code KKY, 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 | 1 | — | 0 | 0 |
| 2008 | 1 | — | 4 | 3 |
| 2009 | 0 | — | 0 | 9 |
| 2010 | 1 | — | 0 | 5 |
| 2011 | 1 | — | 0 | 13 |
| 2012 | 0 | — | 0 | 22 |
| 2013 | 1 | — | 1 | 17 |
| 2014 | 3 | 224 | 0 | 9 |
| 2015 | 1 | — | 0 | 18 |
| 2016 | 2 | — | 0 | 25 |
| 2017 | 0 | — | 0 | 19 |
| 2018 | 0 | — | 0 | 17 |
| 2019 | 0 | — | 0 | 20 |
| 2020 | 0 | — | 0 | 13 |
| 2021 | 1 | — | 0 | 12 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 3 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Porous HDPE Surgical Implants in block, sheet, and anatomical shapes are intended for the augmentation or reconstruction of the craniomaxillofacial skeleton.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022665 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022665: Porous Hdpe Surgical Implants, to BE Distributed Under Various Trademarks Including Epor, Biopor, Minopor & P-Hdpe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022665
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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