510(k) · Cleared
ClearedAoc Porous Polyethylene, Aoc Porous Hdpe, Aoc Porous Polyethylene Surgical Implant, Cerepor
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 Mar 2, 2005 as substantially equivalent to K022665 (Hohenstein Enterprises, Inc., 2002) and 4 other predicates after a 110-day review. Its family tree reaches back 3 generations to 1979. 2 of the 51 devices in its family, counting itself, have a Class I recall. 43 later devices descend from it.
- Decided
- Mar 2, 2005
- Review
- 110 days
- Class
- Class II
- Product code
- KKY
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 3 generations to K791495 (1979). 7 ancestors in all. 43 later devices descend from it, 2 citing it directly. 2 of the 51 devices in this family, counting this one, have a Class I recall.
- Root · 3 generations backK791495 Lukens Bone Wax (Gamma Radiation)Lukens Corp. · 1979
- 2 generations backK971680 Auto Suture Bone WaxUnited States Surgical, A Division of Tyco Healthc · 1997
- 1 generation backK041363 Aoc Bone WaxCeremed, Inc. · 2004 · Recalled
- This deviceK043133 Aoc Porous Polyethylene, Aoc Porous Hdpe, Aoc Porous Polyethylene…Ceremed, Inc. · 2005
- Descendant · cites it directly · 38 of its ownK062280 Ostene, Aoc, Osteotene, Ceretene, Cerepor, Aptene, Apatene and…Ceremed, Inc. · 2006
- Descendant · 2 generations on · 29 of its ownK070093 Ostene, Aoc, Osteotene, Ceretene, Cerepor, Aptene, Apatene, ActipasteCeremed, Inc. · 2007
- Descendant · 3 generations on · 28 of its ownK082491 Ostene CT Soluble Bone Hemostasis Implant Material, Aoc CT, Aoc…Ceremed, Inc. · 2008
- Descendant · 4 generations on · 20 of its ownK091636 Ostene CT, Aoc CT, Osteotene, CereteneCeremed, Inc. · 2009
- Descendant · 2 generations on · 18 of its ownK111538 Skaffold CisSkeletal Kinetics, LLC · 2011
Showing 5 of 43 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 43 · See all- K062280Ostene, Aoc, Osteotene, Ceretene, Cerepor, Aptene, Apatene and ActipasteCeremed, Inc. · 2006 · cites it directly38descendants
- K070093Ostene, Aoc, Osteotene, Ceretene, Cerepor, Aptene, Apatene, ActipasteCeremed, Inc. · 2007 · 2 generations on29descendants
- K082491Ostene CT Soluble Bone Hemostasis Implant Material, Aoc CT, Aoc, Ostene, Osteotene &…Ceremed, Inc. · 2008 · 3 generations on28descendants
- K091636Ostene CT, Aoc CT, Osteotene, CereteneCeremed, Inc. · 2009 · 4 generations on20descendants
- K111538Skaffold CisSkeletal Kinetics, LLC · 2011 · 2 generations on18descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K791495 | Lukens Bone Wax (Gamma Radiation) | Lukens Corp. | 1979 | — |
| −2 | K971680 | Auto Suture Bone Wax | United States Surgical, A Division of Tyco Healthc | 1997 | — |
| −1 | K041363 | Aoc Bone Wax | Ceremed, Inc. | 2004 | 1 |
| 0 (this device) | K043133 | Aoc Porous Polyethylene, Aoc Porous Hdpe, Aoc Porous Polyethylene Surgical… | Ceremed, Inc. | 2005 | — |
| +1 | K062280 | Ostene, Aoc, Osteotene, Ceretene, Cerepor, Aptene, Apatene and Actipaste | Ceremed, Inc. | 2006 | — |
| +2 | K070093 | Ostene, Aoc, Osteotene, Ceretene, Cerepor, Aptene, Apatene, Actipaste | Ceremed, Inc. | 2007 | — |
| +3 | K082491 | Ostene CT Soluble Bone Hemostasis Implant Material, Aoc CT, Aoc, Ostene… | Ceremed, Inc. | 2008 | — |
| +4 | K091636 | Ostene CT, Aoc CT, Osteotene, Ceretene | Ceremed, Inc. | 2009 | — |
| +2 | K111538 | Skaffold Cis | Skeletal Kinetics, LLC | 2011 | — |
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 |
|---|---|---|
| 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 KKY device
- #1 K211514 Longeviti PorousFit implantscore 2.0 · 2 generations · no Class I recall
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | K022665 | Porous Hdpe Surgical Implants, to BE Distributed Under Various Trademarks Including…Summary page 1…rous Polyethylene (per 21 CFR section 874.3620) Predicate Devices I. ePor, Inc. Porous HDPE Surgical Implants K022665 2. Ceremed, Inc. AOCTM Bone Wax K041363 3. Porex Surgical Inc. MEDPOR® Surgical Implant Material: Prefo… | 2002 |
| * | K041363 | Aoc Bone WaxSummary page 1…ne (per 21 CFR section 874.3620) Predicate Devices I. ePor, Inc. Porous HDPE Surgical Implants K022665 2. Ceremed, Inc. AOCTM Bone Wax K041363 3. Porex Surgical Inc. MEDPOR® Surgical Implant Material: Preformed Cranial and Facial Implants K922489 4. Po… | 2004 |
| * | K922489 | Medpor Surg Implant Material:Prefor Cran/Fac ImplaSummary page 1…5 2. Ceremed, Inc. AOCTM Bone Wax K041363 3. Porex Surgical Inc. MEDPOR® Surgical Implant Material: Preformed Cranial and Facial Implants K922489 4. Porex Surgical Inc. MEDPOR® Plus Surgical Implant Biomaterial K012350 5. Porex Surgical Inc. MEDPOR®… | 1992 |
| * | K012350 | Medpor Plus Surgical Implant BiomaterialSummary page 1…MEDPOR® Surgical Implant Material: Preformed Cranial and Facial Implants K922489 4. Porex Surgical Inc. MEDPOR® Plus Surgical Implant Biomaterial K012350 5. Porex Surgical Inc. MEDPOR® Craniofacial Implants with embedded Titanium Mesh K040364… | 2002 |
| * | K040364 | Medpor Craniofacial Implants with Embedded Titanium MeshSummary page 1…gical Inc. MEDPOR® Plus Surgical Implant Biomaterial K012350 5. Porex Surgical Inc. MEDPOR® Craniofacial Implants with embedded Titanium Mesh K040364 Fage-7'-r -… | 2004 |
What descends from it? (43)
See all 432 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 · 4 generations on · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
- K113079Synthes Hemostatic Bone PuttySynthes (Usa) Products, LLC/Norian Corporation · 2011 · 4 generations on · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 26 years and passes through 3 companies; a new generation was cleared every 6.8 years on median.
- 3 of the 7 ancestors have a recall of any class.
- Of its descendants, K062280 (Ceremed, Inc., 2006) has gone furthest, with 38 descendants of its own.
- 2 other devices also cite its predicate K022665.
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?
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/K043133 · printed Nov 6, 2026
Cite this page
510(k) Report. “K043133: Aoc Porous Polyethylene, Aoc Porous Hdpe, Aoc Porous Polyethylene Surgical Implant, Cerepor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K043133
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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