510(k) · Cleared
ClearedOstene, Aoc, Osteotene, Ceretene, Cerepor, Aptene, Apatene and Actipaste
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 Dec 11, 2006 as substantially equivalent to K043133 (Ceremed, Inc., 2005) and 2 other predicates after a 126-day review. Its family tree reaches back 5 generations to 1979. 2 of the 49 devices in its family, counting itself, have a Class I recall. 38 later devices descend from it.
- Decided
- Dec 11, 2006
- Review
- 126 days
- Class
- Class II
- Product code
- KHJ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K791495 (1979). 10 ancestors in all. 38 later devices descend from it, 3 citing it directly. 2 of the 49 devices in this family, counting this one, have a Class I recall.
- Root · 5 generations backK791495 Lukens Bone Wax (Gamma Radiation)Lukens Corp. · 1979
- 4 generations backK971680 Auto Suture Bone WaxUnited States Surgical, A Division of Tyco Healthc · 1997
- 3 generations backK041363 Aoc Bone WaxCeremed, Inc. · 2004 · Recalled
- 2 generations backK050440 Aoc Bone Wax, Ostene, Osteotene, Orthoseal, Osteoseal, Ceretene…Ceremed, Inc. · 2005
- 1 generation backK052528 Aoc Bone Wax Ostene, Osteotene and CereteneCeremed, Inc. · 2005
- This deviceK062280 Ostene, Aoc, Osteotene, Ceretene, Cerepor, Aptene, Apatene and…Ceremed, Inc. · 2006
- Descendant · cites it directly · 29 of its ownK070093 Ostene, Aoc, Osteotene, Ceretene, Cerepor, Aptene, Apatene, ActipasteCeremed, Inc. · 2007
- Descendant · 2 generations on · 28 of its ownK082491 Ostene CT Soluble Bone Hemostasis Implant Material, Aoc CT, Aoc…Ceremed, Inc. · 2008
- Descendant · 3 generations on · 20 of its ownK091636 Ostene CT, Aoc CT, Osteotene, CereteneCeremed, Inc. · 2009
- Descendant · cites it directly · 18 of its ownK111538 Skaffold CisSkeletal Kinetics, LLC · 2011
- Descendant · 4 generations on · 17 of its ownK102071 Ostene CT, Aoc CT, Osteotene, CereteneCeremed, Inc. · 2010
Showing 5 of 38 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 38 · See all- K070093Ostene, Aoc, Osteotene, Ceretene, Cerepor, Aptene, Apatene, ActipasteCeremed, Inc. · 2007 · cites it directly29descendants
- K082491Ostene CT Soluble Bone Hemostasis Implant Material, Aoc CT, Aoc, Ostene, Osteotene &…Ceremed, Inc. · 2008 · 2 generations on28descendants
- K091636Ostene CT, Aoc CT, Osteotene, CereteneCeremed, Inc. · 2009 · 3 generations on20descendants
- K111538Skaffold CisSkeletal Kinetics, LLC · 2011 · cites it directly18descendants
- K102071Ostene CT, Aoc CT, Osteotene, CereteneCeremed, Inc. · 2010 · 4 generations on17descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K791495 | Lukens Bone Wax (Gamma Radiation) | Lukens Corp. | 1979 | — |
| −4 | K971680 | Auto Suture Bone Wax | United States Surgical, A Division of Tyco Healthc | 1997 | — |
| −3 | K041363 | Aoc Bone Wax | Ceremed, Inc. | 2004 | 1 |
| −2 | K050440 | Aoc Bone Wax, Ostene, Osteotene, Orthoseal, Osteoseal, Ceretene, Model BW-12 | Ceremed, Inc. | 2005 | — |
| −1 | K052528 | Aoc Bone Wax Ostene, Osteotene and Ceretene | Ceremed, Inc. | 2005 | — |
| 0 (this device) | K062280 | Ostene, Aoc, Osteotene, Ceretene, Cerepor, Aptene, Apatene and Actipaste | Ceremed, Inc. | 2006 | — |
| +1 | K070093 | Ostene, Aoc, Osteotene, Ceretene, Cerepor, Aptene, Apatene, Actipaste | Ceremed, Inc. | 2007 | — |
| +2 | K082491 | Ostene CT Soluble Bone Hemostasis Implant Material, Aoc CT, Aoc, Ostene… | Ceremed, Inc. | 2008 | — |
| +3 | K091636 | Ostene CT, Aoc CT, Osteotene, Ceretene | Ceremed, Inc. | 2009 | — |
| +1 | K111538 | Skaffold Cis | Skeletal Kinetics, LLC | 2011 | — |
| +4 | K102071 | Ostene CT, Aoc CT, Osteotene, Ceretene | Ceremed, Inc. | 2010 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 5 | 2 |
| 2012 | 4 | 0 |
| 2013 | 3 | 0 |
| 2014 | 4 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 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 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? (3)
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…21 CFR 874.3620) Product Code: KHJ t AA '" Predicate Devices 1. Ceremed, Inc. AOC" Porous Polyethylene Surgical Implants K043133 2. Ceremed, Inc. AOC Bone Wax T K041363 3. Ceremed, Inc. AOC Bone Wax (Ostene®)… | 2005 |
| * | K041363 | Aoc Bone WaxSummary page 1…Predicate Devices 1. Ceremed, Inc. AOC" Porous Polyethylene Surgical Implants K043133 2. Ceremed, Inc. AOC Bone Wax T K041363 3. Ceremed, Inc. AOC Bone Wax (Ostene®) T K052528 4. Genzyme Corp. SepragelT ENT… | 2004 |
| * | K052528 | Aoc Bone Wax Ostene, Osteotene and CereteneSummary page 1…ts K043133 2. Ceremed, Inc. AOC Bone Wax T K041363 3. Ceremed, Inc. AOC Bone Wax (Ostene®) T K052528 4. Genzyme Corp. SepragelT ENT K043035 5. Medtronic Xomed, Inc. MeroGel TM Injectable K0029… | 2005 |
| † | K043035 | Sepragel Ent Bioresorbable Packing/Stent | 2005 |
| † | K002972 | Merogel Control Gel Ent Surgical Dressing | 2000 |
What descends from it? (38)
See all 383 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 · 3 generations on · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
- K113079Synthes Hemostatic Bone PuttySynthes (Usa) Products, LLC/Norian Corporation · 2011 · 3 generations on · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 27 years and passes through 3 companies; a new generation was cleared every 1.2 years on median.
- 3 of the 10 ancestors have a recall of any class.
- Of its descendants, K070093 (Ceremed, Inc., 2007) has gone furthest, with 29 descendants of its own.
- 1 other device also cites its predicate K043133.
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.
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?
OSTENE® is indicated for use as a water-soluble implant material for use in the control of bleeding from bone surfaces and as a water-soluble space occupying material as an adjunct during the natural healing process.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062280 · printed Nov 4, 2026
Cite this page
510(k) Report. “K062280: Ostene, Aoc, Osteotene, Ceretene, Cerepor, Aptene, Apatene and Actipaste.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062280
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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