510(k) · Cleared
ClearedOrthocon LLC Orthostat Hemostatic Bone Putty
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orthocon, LLC · MTJ Wax, Bone
Cleared on Aug 12, 2005 as substantially equivalent to K024372 (Cp Medical, 2003) and 5 other predicates after a 261-day review. Its family tree reaches back 3 generations to 1979. 14 later devices descend from it.
- Decided
- Aug 12, 2005
- Review
- 261 days
- Class
- Class U
- Product code
- MTJ
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 3 generations to K791495 (1979). 7 ancestors in all. 14 later devices descend from it, 7 citing it directly.
- 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 backK024372 CP Medical Bone WaxCp Medical · 2003
- This deviceK043260 Orthocon LLC Orthostat Hemostatic Bone PuttyOrthocon, LLC · 2005
- Descendant · cites it directly · 10 of its ownK091121 OrthostatOrthocon, Inc. · 2009
- Descendant · cites it directly · 9 of its ownK102762 Orthostat Bone Hemostat Matrix ApplicatorOrthocon, Inc. · 2011
- Descendant · cites it directly · 6 of its ownK111575 Hemasorb Absorbable Bone Hemostat MatrixOrthocon, Inc. · 2012
- Descendant · 2 generations on · 3 of its ownK213418 MONTAGE Settable, Resorbable Hemostatic Bone PuttyOrthocon, Inc. · 2023
- Descendant · 3 generations on · 1 of its ownK242050 Montage Settable Bone PuttyOrthocon, Inc. · 2024
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K091121OrthostatOrthocon, Inc. · 2009 · cites it directly10descendants
- K102762Orthostat Bone Hemostat Matrix ApplicatorOrthocon, Inc. · 2011 · cites it directly9descendants
- K111575Hemasorb Absorbable Bone Hemostat MatrixOrthocon, Inc. · 2012 · cites it directly6descendants
- K213418MONTAGE Settable, Resorbable Hemostatic Bone PuttyOrthocon, Inc. · 2023 · 2 generations on3descendants
- K242050Montage Settable Bone PuttyOrthocon, Inc. · 2024 · 3 generations on1descendant
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 | K024372 | CP Medical Bone Wax | Cp Medical | 2003 | — |
| 0 (this device) | K043260 | Orthocon LLC Orthostat Hemostatic Bone Putty | Orthocon, LLC | 2005 | — |
| +1 | K091121 | Orthostat | Orthocon, Inc. | 2009 | — |
| +1 | K102762 | Orthostat Bone Hemostat Matrix Applicator | Orthocon, Inc. | 2011 | — |
| +1 | K111575 | Hemasorb Absorbable Bone Hemostat Matrix | Orthocon, Inc. | 2012 | — |
| +2 | K213418 | MONTAGE Settable, Resorbable Hemostatic Bone Putty | Orthocon, Inc. | 2023 | — |
| +3 | K242050 | Montage Settable Bone Putty | Orthocon, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2000 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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), 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 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? (7)
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 |
|---|---|---|---|
| * | K024372 | CP Medical Bone WaxSummary page 1…", Product code: MTJ Unclassified Predicate Devices CP Medical, Inc. - CP Medical Bone Wax 510(k) Number K024372 Ethicon, Inc. Bone Wax - Pre-enactment United States Surgical Corporation Bone Wax… | 2003 |
| * | K032930 | Ultraflex Esophageal NG Stent SystemSummary page 2…oStatTM Hemostatic Bone Putty is substantially equivalent to a number of pre-enactment and previously cleared devices, including: CP Medical Bone Wax - [501(k) Number K032930] Lukens Bone Wax - [510(k) K791495] Aesculap Bone Wax - [510(k) K000021] Ethicon Bone Wax - Pre-enactment United States Surgi… | 2003 |
| * | K971680 | Auto Suture Bone WaxSummary page 1…r K024372 Ethicon, Inc. Bone Wax - Pre-enactment United States Surgical Corporation Bone Wax 510(k) Number K971680 (Absorbable) Ceremed AOC Bone Wax 510(k) Number K041363… | 1997 |
| * | K041363 | Aoc Bone WaxSummary page 1…rporation Bone Wax 510(k) Number K971680 (Absorbable) Ceremed AOC Bone Wax 510(k) Number K041363 (Absorbable) Description Orthocon OrthoStatTM Hemostatic Bone Putty is a sterile, soft, moldable, biocompat… | 2004 |
| * | K791495 | Lukens Bone Wax (Gamma Radiation)Summary page 2…bstantially equivalent to a number of pre-enactment and previously cleared devices, including: CP Medical Bone Wax - [501(k) Number K032930] Lukens Bone Wax - [510(k) K791495] Aesculap Bone Wax - [510(k) K000021] Ethicon Bone Wax - Pre-enactment United States Surgical Corporation Bone Wax - [510(k) N… | 1979 |
| * | K000021 | Aesculap Bone WaxSummary page 2…pre-enactment and previously cleared devices, including: CP Medical Bone Wax - [501(k) Number K032930] Lukens Bone Wax - [510(k) K791495] Aesculap Bone Wax - [510(k) K000021] Ethicon Bone Wax - Pre-enactment United States Surgical Corporation Bone Wax - [510(k) Number K971680] (Absorbable) Ceremed A… | 2000 |
| * | — | Ethicon Bone Wax Named without a submission number |
What descends from it? (14)
See all 147 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K091121 | Orthostat | 2009 | 10 |
| K102762 | Orthostat Bone Hemostat Matrix Applicator | 2011 | 9 |
| K111575 | Hemasorb Absorbable Bone Hemostat Matrix | 2012 | 6 |
| K113627 | Hemasorb Resorbable Hemostatic Bone Putty | 2012 | 1 |
| K063330 | Orthocon Hemasorb Resorbable Hemostatic Bone Putty | 2006 | 1 |
| K142339 | HEMASORB Resorbable Hemostatic Bone Putty | 2014 | 0 |
| K060987 | OSCERA7 Synthetic Absorbable Bone Wax, Model OS31 | 2006 | 0 |
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 26 years and passes through 4 companies; a new generation was cleared every 5.7 years on median.
- 2 of the 7 ancestors have a recall of any class.
- Of its descendants, K091121 (Orthocon, Inc., 2009) has gone furthest, with 10 descendants of its own.
- 5 other devices also cite its predicate K024372.
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?
The Orthocon OrthoStat TM Hemostatic Bone Putty is indicated for use in the control of bleeding from cut or damaged bone by acting as a mechanical barrier or tamponade. The material may be used during surgical procedures and in treating traumatic injuries.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043260 · printed Nov 6, 2026
Cite this page
510(k) Report. “K043260: Orthocon LLC Orthostat Hemostatic Bone Putty.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K043260
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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