510(k) · Cleared
ClearedAoc Porous Polyethylene, Aoc Porous Hdpe, Aoc Porous Polyethylene Surgical Implant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ceremed, Inc. · KKY Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
Cleared on Apr 21, 2008 as substantially equivalent to K043133 (Ceremed, Inc., 2005) and 1 other predicate after a 56-day review. Its family tree reaches back 4 generations to 1979. 9 later devices descend from it.
- Decided
- Apr 21, 2008
- Review
- 56 days
- Class
- Class II
- Product code
- KKY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K791495 (1979). 8 ancestors in all. 9 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK791495 Lukens Bone Wax (Gamma Radiation)Lukens Corp. · 1979
- 3 generations backK971680 Auto Suture Bone WaxUnited States Surgical, A Division of Tyco Healthc · 1997
- 2 generations backK041363 Aoc Bone WaxCeremed, Inc. · 2004 · Recalled
- 1 generation backK043133 Aoc Porous Polyethylene, Aoc Porous Hdpe, Aoc Porous Polyethylene…Ceremed, Inc. · 2005
- This deviceK080507 Aoc Porous Polyethylene, Aoc Porous Hdpe, Aoc Porous Polyethylene…Ceremed, Inc. · 2008
- Descendant · cites it directly · 5 of its ownK081531 Aoc Soluble Implant MaterialCeremed, Inc. · 2008
- Descendant · 2 generations on · 2 of its ownK120220 Adaptain Soluble Implant MaterialCeremed, Inc. · 2012
- Descendant · cites it directly · 2 of its ownK111323 Synthes Synpor HD Porous Polyethylene Threr Dimensional ImplantsSynthes, Inc. · 2011
- Descendant · 2 generations on · 1 of its ownK133809 Osteofab Patient Specific Facial DeviceOxford Performance Materials · 2014
- Descendant · 3 generations on · 1 of its ownK122561 Adaptain Fastwrap, Envelock, GraftainCeremed, Inc. · 2012
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K081531Aoc Soluble Implant MaterialCeremed, Inc. · 2008 · cites it directly5descendants
- K120220Adaptain Soluble Implant MaterialCeremed, Inc. · 2012 · 2 generations on2descendants
- K111323Synthes Synpor HD Porous Polyethylene Threr Dimensional ImplantsSynthes, Inc. · 2011 · cites it directly2descendants
- K133809Osteofab Patient Specific Facial DeviceOxford Performance Materials · 2014 · 2 generations on1descendant
- K122561Adaptain Fastwrap, Envelock, GraftainCeremed, Inc. · 2012 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K791495 | Lukens Bone Wax (Gamma Radiation) | Lukens Corp. | 1979 | — |
| −3 | K971680 | Auto Suture Bone Wax | United States Surgical, A Division of Tyco Healthc | 1997 | — |
| −2 | K041363 | Aoc Bone Wax | Ceremed, Inc. | 2004 | 1 |
| −1 | K043133 | Aoc Porous Polyethylene, Aoc Porous Hdpe, Aoc Porous Polyethylene Surgical… | Ceremed, Inc. | 2005 | — |
| 0 (this device) | K080507 | Aoc Porous Polyethylene, Aoc Porous Hdpe, Aoc Porous Polyethylene Surgical… | Ceremed, Inc. | 2008 | — |
| +1 | K081531 | Aoc Soluble Implant Material | Ceremed, Inc. | 2008 | — |
| +2 | K120220 | Adaptain Soluble Implant Material | Ceremed, Inc. | 2012 | — |
| +1 | K111323 | Synthes Synpor HD Porous Polyethylene Threr Dimensional Implants | Synthes, Inc. | 2011 | — |
| +2 | K133809 | Osteofab Patient Specific Facial Device | Oxford Performance Materials | 2014 | — |
| +3 | K122561 | Adaptain Fastwrap, Envelock, Graftain | Ceremed, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 2002 | 2 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 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 KKY? 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? (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 |
|---|---|---|---|
| * | K043133 | Aoc Porous Polyethylene, Aoc Porous Hdpe, Aoc Porous Polyethylene Surgical Implant…Summary page 1…Polyethylene (per 21 CFR section 874.3620) Predicate Devices 1. Ceremed, Inc. AOC T M Porous Polyethylene Surgical Implants K043133 2. Porex Surgical Inc. MEDPOR® Craniofacial Implants with embedded Titanium Mesh K040364… | 2005 |
| * | K040364 | Medpor Craniofacial Implants with Embedded Titanium MeshSummary page 1…. AOC T M Porous Polyethylene Surgical Implants K043133 2. Porex Surgical Inc. MEDPOR® Craniofacial Implants with embedded Titanium Mesh K040364 9"5~e ~ 2… | 2004 |
What descends from it? (9)
2 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?
- The line of descent spans 29 years and passes through 3 companies; a new generation was cleared every 6.8 years on median.
- 3 of the 8 ancestors have a recall of any class.
- Of its descendants, K081531 (Ceremed, Inc., 2008) has gone furthest, with 5 descendants of its own.
- 1 other device also cites its predicate K043133.
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. 2008, this device’s year, is highlighted.
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?
AOC™ Porous Polyethylene Surgical Implants are intended for the augmentation or reconstruction of the craniomaxillofacial skeleton.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080507 · printed Nov 3, 2026
Cite this page
510(k) Report. “K080507: Aoc Porous Polyethylene, Aoc Porous Hdpe, Aoc Porous Polyethylene Surgical Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080507
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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