510(k) · Cleared
ClearedAoc Soluble Implant Material
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ceremed, Inc. · KHJ Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)
Cleared on Jul 18, 2008 as substantially equivalent to K062280 (Ceremed, Inc., 2006) and 1 other predicate after a 46-day review. Its family tree reaches back 6 generations to 1979. 5 later devices descend from it.
- Decided
- Jul 18, 2008
- Review
- 46 days
- Class
- Class II
- Product code
- KHJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K791495 (1979). 12 ancestors in all. 5 later devices descend from it, 3 citing it directly.
- Root · 6 generations backK791495 Lukens Bone Wax (Gamma Radiation)Lukens Corp. · 1979
- 5 generations backK971680 Auto Suture Bone WaxUnited States Surgical, A Division of Tyco Healthc · 1997
- 4 generations backK041363 Aoc Bone WaxCeremed, Inc. · 2004 · Recalled
- 3 generations backK050440 Aoc Bone Wax, Ostene, Osteotene, Orthoseal, Osteoseal, Ceretene…Ceremed, Inc. · 2005
- 2 generations backK052528 Aoc Bone Wax Ostene, Osteotene and CereteneCeremed, Inc. · 2005
- 1 generation backK062280 Ostene, Aoc, Osteotene, Ceretene, Cerepor, Aptene, Apatene and…Ceremed, Inc. · 2006
- This deviceK081531 Aoc Soluble Implant MaterialCeremed, Inc. · 2008
- Descendant · cites it directly · 2 of its ownK120220 Adaptain Soluble Implant MaterialCeremed, Inc. · 2012
- Descendant · 2 generations on · 1 of its ownK122561 Adaptain Fastwrap, Envelock, GraftainCeremed, Inc. · 2012
- Descendant · 3 generations on · 0 of its ownK132198 Adaptain, Adaptain Fastwrap, Envelock, BiowaiCeremed, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK103047 Ceretene Soluble Implant MaterialCeremed, Inc. · 2011
- Descendant · cites it directly · 0 of its ownK082245 Aoc, Ostene, Aoc Implant Material, Ceretene, Ostene Lube, Aoc-LVCeremed, Inc. · 2008
Most influential descendants
Showing 5 of 5 · See all- K120220Adaptain Soluble Implant MaterialCeremed, Inc. · 2012 · cites it directly2descendants
- K122561Adaptain Fastwrap, Envelock, GraftainCeremed, Inc. · 2012 · 2 generations on1descendant
- K132198Adaptain, Adaptain Fastwrap, Envelock, BiowaiCeremed, Inc. · 2013 · 3 generations on0descendants
- K103047Ceretene Soluble Implant MaterialCeremed, Inc. · 2011 · cites it directly0descendants
- K082245Aoc, Ostene, Aoc Implant Material, Ceretene, Ostene Lube, Aoc-LVCeremed, Inc. · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K791495 | Lukens Bone Wax (Gamma Radiation) | Lukens Corp. | 1979 | — |
| −5 | K971680 | Auto Suture Bone Wax | United States Surgical, A Division of Tyco Healthc | 1997 | — |
| −4 | K041363 | Aoc Bone Wax | Ceremed, Inc. | 2004 | 1 |
| −3 | K050440 | Aoc Bone Wax, Ostene, Osteotene, Orthoseal, Osteoseal, Ceretene, Model BW-12 | Ceremed, Inc. | 2005 | — |
| −2 | K052528 | Aoc Bone Wax Ostene, Osteotene and Ceretene | Ceremed, Inc. | 2005 | — |
| −1 | K062280 | Ostene, Aoc, Osteotene, Ceretene, Cerepor, Aptene, Apatene and Actipaste | Ceremed, Inc. | 2006 | — |
| 0 (this device) | K081531 | Aoc Soluble Implant Material | Ceremed, Inc. | 2008 | — |
| +1 | K120220 | Adaptain Soluble Implant Material | Ceremed, Inc. | 2012 | — |
| +2 | K122561 | Adaptain Fastwrap, Envelock, Graftain | Ceremed, Inc. | 2012 | — |
| +3 | K132198 | Adaptain, Adaptain Fastwrap, Envelock, Biowai | Ceremed, Inc. | 2013 | — |
| +1 | K103047 | Ceretene Soluble Implant Material | Ceremed, Inc. | 2011 | — |
| +1 | K082245 | Aoc, Ostene, Aoc Implant Material, Ceretene, Ostene Lube, Aoc-LV | Ceremed, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 2002 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 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 KHJ? 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 KHJ device
- #1 K260266 Tympendi™ (810)score 12.2 · 2 generations · no Class I recall
- #2 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 |
|---|---|---|---|
| * | K062280 | Ostene, Aoc, Osteotene, Ceretene, Cerepor, Aptene, Apatene and ActipasteSummary page 1…material (per 21 CFR section 874.3620) Product Code KHJ Predicate Devices I1. Ceremned, Inc. Ostenee Soluble Implant Material (K062280) 2. Ceremed, Inc. AOCTrm Porous Polyethylene Surgical Implants (KO80507) DEPARTMENT OF HEALTH & H… | 2006 |
| * | K080507 | Aoc Porous Polyethylene, Aoc Porous Hdpe, Aoc Porous Polyethylene Surgical Implant | 2008 |
What descends from it? (5)
3 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 1.6 years on median.
- 3 of the 12 ancestors have a recall of any class.
- Of its descendants, K120220 (Ceremed, Inc., 2012) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K062280.
How does its category compare?
All KHJ devicesKHJ Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material): FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · KHJ
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · KHJ
46in 2008
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KHJ
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KHJ
1in 2025
MAUDE reports naming product code KHJ, 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 | 3 | 46 | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 4 |
| 2012 | 2 | — | 0 | 2 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 1 | — | 1 | 1 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 4 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 3 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 1 | — | 1 | 0 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
space occupying material, as an adjunct during the natural healing process.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081531 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081531: Aoc Soluble Implant Material.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081531
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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