510(k) · Cleared
Recalled · Class II · 2023Aoc Bone Wax
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ceremed, Inc. · MTJ Wax, Bone
Cleared on Jul 27, 2004 as substantially equivalent to K971680 (United States Surgical, A Division of Tyco Healthc, 1997) and 1 other predicate after a 67-day review. Its family tree reaches back 2 generations to 1979. 2 of the 55 devices in its family, counting itself, have a Class I recall. 52 later devices descend from it. It has been recalled once.
- Decided
- Jul 27, 2004
- Review
- 67 days
- Class
- Class U
- Product code
- MTJ
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 2 generations to K791495 (1979). 52 later devices descend from it, 7 citing it directly. 2 of the 55 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK791495 Lukens Bone Wax (Gamma Radiation)Lukens Corp. · 1979
- 1 generation backK971680 Auto Suture Bone WaxUnited States Surgical, A Division of Tyco Healthc · 1997
- This deviceK041363 Aoc Bone WaxCeremed, Inc. · 2004
- Descendant · cites it directly · 43 of its ownK043133 Aoc Porous Polyethylene, Aoc Porous Hdpe, Aoc Porous Polyethylene…Ceremed, Inc. · 2005
- Descendant · cites it directly · 40 of its ownK050440 Aoc Bone Wax, Ostene, Osteotene, Orthoseal, Osteoseal, Ceretene…Ceremed, Inc. · 2005
- Descendant · cites it directly · 39 of its ownK052528 Aoc Bone Wax Ostene, Osteotene and CereteneCeremed, 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
Showing 5 of 52 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 52 · See all- K043133Aoc Porous Polyethylene, Aoc Porous Hdpe, Aoc Porous Polyethylene Surgical Implant…Ceremed, Inc. · 2005 · cites it directly43descendants
- K050440Aoc Bone Wax, Ostene, Osteotene, Orthoseal, Osteoseal, Ceretene, Model BW-12Ceremed, Inc. · 2005 · cites it directly40descendants
- K052528Aoc Bone Wax Ostene, Osteotene and CereteneCeremed, Inc. · 2005 · cites it directly39descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K791495 | Lukens Bone Wax (Gamma Radiation) | Lukens Corp. | 1979 | — |
| −1 | K971680 | Auto Suture Bone Wax | United States Surgical, A Division of Tyco Healthc | 1997 | — |
| 0 (this device) | K041363 | Aoc Bone Wax | Ceremed, Inc. | 2004 | — |
| +1 | K043133 | Aoc Porous Polyethylene, Aoc Porous Hdpe, Aoc Porous Polyethylene Surgical… | Ceremed, Inc. | 2005 | — |
| +1 | 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 | — |
| +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 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 4 | 0 |
| 2006 | 3 | 0 |
| 2007 | 1 | 0 |
| 2008 | 4 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 7 | 2 |
| 2012 | 5 | 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 MTJ device
- #1 K262769 Permatage XT Settable Nonabsorbable Hemostatic…score 15.5 · 13 generations · no Class I recall
- #2 Held for the reportin the report
- #3 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 |
|---|---|---|---|
| * | K971680 | Auto Suture Bone WaxSummary page 1…Inc. Ethicon Bone Wax Preamendment 5. US Surgical, Inc. Auto Suture Bone Wax K971680 6. Lukens Corp. Lukens Bone Wax K791495 Description of the device:… | 1997 |
| * | K791495 | Lukens Bone Wax (Gamma Radiation)Summary page 1…urgical, Inc. Auto Suture Bone Wax K971680 6. Lukens Corp. Lukens Bone Wax K791495 Description of the device: directly AOC Bone… | 1979 |
| * | — | Ethicon Bone Wax Named without a submission number |
What descends from it? (52)
See all 527 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K043133 | Aoc Porous Polyethylene, Aoc Porous Hdpe, Aoc Porous Polyethylene Surgical Implant… | 2005 | 43 |
| K050440 | Aoc Bone Wax, Ostene, Osteotene, Orthoseal, Osteoseal, Ceretene, Model BW-12 | 2005 | 40 |
| K052528 | Aoc Bone Wax Ostene, Osteotene and Ceretene | 2005 | 39 |
| K062280 | Ostene, Aoc, Osteotene, Ceretene, Cerepor, Aptene, Apatene and Actipaste | 2006 | 38 |
| K123243 | Hemasorb Bone Putty 3 Resorbable Hemostatic Bone Putty | 2013 | 16 |
| K043260 | Orthocon LLC Orthostat Hemostatic Bone Putty | 2005 | 14 |
| K122156 | Orthocon Absorbable Hemostatic Bone Putty | 2013 | 3 |
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 6, 2023 | Class II | Z-0658-2024 | Under Investigation by firm | Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the products Instructions for Use (IFU) or Prescribing Information… |
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 25 years and passes through 3 companies; a new generation was cleared every 18.1 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K043133 (Ceremed, Inc., 2005) has gone furthest, with 43 descendants of its own.
- 7 other devices also cite its predicate K971680.
How does its category compare?
All MTJ devicesMTJ Wax, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MTJ
4in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · MTJ
370in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MTJ
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MTJ
22in 2025
MAUDE reports naming product code MTJ, 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 | 0 | — | 0 | 2 |
| 2008 | 1 | — | 1 | 1 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 5 | 140 | 0 | 2 |
| 2012 | 3 | 141 | 0 | 8 |
| 2013 | 2 | — | 0 | 5 |
| 2014 | 4 | 46 | 0 | 6 |
| 2015 | 2 | — | 0 | 11 |
| 2016 | 2 | — | 0 | 7 |
| 2017 | 0 | — | 0 | 7 |
| 2018 | 0 | — | 0 | 12 |
| 2019 | 1 | — | 0 | 17 |
| 2020 | 1 | — | 0 | 16 |
| 2021 | 1 | — | 0 | 12 |
| 2022 | 1 | — | 0 | 31 |
| 2023 | 4 | 370 | 1 | 20 |
| 2024 | 0 | — | 0 | 32 |
| 2025 | 0 | — | 0 | 22 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
AOC Bone Wax is indicated for use in the control of bleeding from bone surfaces.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041363 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041363: Aoc Bone Wax.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041363
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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