510(k) · Cleared
ClearedAesculap Bone Wax
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aesculap, Inc. · MTJ Wax, Bone
Cleared on Mar 24, 2000 after an 80-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 15 later devices descend from it.
- Decided
- Mar 24, 2000
- Review
- 80 days
- Class
- Class U
- Product code
- MTJ
- Recalls
- None
- Predicates
- 0
15 later devices descend from it, 1 citing it directly.
- This deviceK000021 Aesculap Bone WaxAesculap, Inc. · 2000
- Descendant · cites it directly · 14 of its ownK043260 Orthocon LLC Orthostat Hemostatic Bone PuttyOrthocon, LLC · 2005
- Descendant · 2 generations on · 10 of its ownK091121 OrthostatOrthocon, Inc. · 2009
- Descendant · 2 generations on · 9 of its ownK102762 Orthostat Bone Hemostat Matrix ApplicatorOrthocon, Inc. · 2011
- Descendant · 2 generations on · 6 of its ownK111575 Hemasorb Absorbable Bone Hemostat MatrixOrthocon, Inc. · 2012
- Descendant · 3 generations on · 3 of its ownK213418 MONTAGE Settable, Resorbable Hemostatic Bone PuttyOrthocon, Inc. · 2023
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K043260Orthocon LLC Orthostat Hemostatic Bone PuttyOrthocon, LLC · 2005 · cites it directly14descendants
- K091121OrthostatOrthocon, Inc. · 2009 · 2 generations on10descendants
- K102762Orthostat Bone Hemostat Matrix ApplicatorOrthocon, Inc. · 2011 · 2 generations on9descendants
- K111575Hemasorb Absorbable Bone Hemostat MatrixOrthocon, Inc. · 2012 · 2 generations on6descendants
- K213418MONTAGE Settable, Resorbable Hemostatic Bone PuttyOrthocon, Inc. · 2023 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K000021 | Aesculap Bone Wax | Aesculap, Inc. | 2000 | — |
| +1 | K043260 | Orthocon LLC Orthostat Hemostatic Bone Putty | Orthocon, LLC | 2005 | — |
| +2 | K091121 | Orthostat | Orthocon, Inc. | 2009 | — |
| +2 | K102762 | Orthostat Bone Hemostat Matrix Applicator | Orthocon, Inc. | 2011 | — |
| +2 | K111575 | Hemasorb Absorbable Bone Hemostat Matrix | Orthocon, Inc. | 2012 | — |
| +3 | K213418 | MONTAGE Settable, Resorbable Hemostatic Bone Putty | Orthocon, Inc. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2009 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 3 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MTJ? 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (15)
See all 151 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K043260 | Orthocon LLC Orthostat Hemostatic Bone Putty | 2005 | 14 |
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?
- Of its descendants, K043260 (Orthocon, LLC, 2005) has gone furthest, with 14 descendants of its own.
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 | — |
https://510kreport.com/device/K000021 · printed Nov 6, 2026
Cite this page
510(k) Report. “K000021: Aesculap 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/K000021
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026