510(k) · Cleared
ClearedOrthostat
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orthocon, Inc. · MTJ Wax, Bone
Cleared on Apr 28, 2009 as substantially equivalent to K043260 (Orthocon, LLC, 2005) after an 11-day review. Its family tree reaches back 4 generations to 1979. 10 later devices descend from it.
- Decided
- Apr 28, 2009
- Review
- 11 days
- Class
- Class U
- Product code
- MTJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K791495 (1979). 8 ancestors in all. 10 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK791495 Lukens Bone Wax (Gamma Radiation)Lukens Corp. · 1979
- 3 generations backK971680 Auto Suture Bone WaxUnited States Surgical, A Division of Tyco Healthc · 1997
- 2 generations backK024372 CP Medical Bone WaxCp Medical · 2003
- 1 generation backK043260 Orthocon LLC Orthostat Hemostatic Bone PuttyOrthocon, LLC · 2005
- This deviceK091121 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
- Descendant · 3 generations on · 1 of its ownK232998 Montage- XT Settable, Resorbable Hemostatic Bone PuttyOrthocon, Inc. · 2023
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- 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
- K232998Montage- XT Settable, Resorbable Hemostatic Bone PuttyOrthocon, Inc. · 2023 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K791495 | Lukens Bone Wax (Gamma Radiation) | Lukens Corp. | 1979 | — |
| −3 | K971680 | Auto Suture Bone Wax | United States Surgical, A Division of Tyco Healthc | 1997 | — |
| −2 | K024372 | CP Medical Bone Wax | Cp Medical | 2003 | — |
| −1 | K043260 | Orthocon LLC Orthostat Hemostatic Bone Putty | Orthocon, LLC | 2005 | — |
| 0 (this device) | 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 | — |
| +3 | K232998 | Montage- XT Settable, Resorbable Hemostatic Bone Putty | Orthocon, Inc. | 2023 | — |
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 |
|---|---|---|
| 2011 | 1 | 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? (1)
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 |
|---|---|---|---|
| * | K043260 | Orthocon LLC Orthostat Hemostatic Bone PuttySummary page 1…"Bone Wax", Product code: MTJ Predicate Device Device Name: OrthostatTM Hemostatic Bone Putty 510(k) Number: 043260 Decision Date: August 12, 2005 Decision: Substantially Equivalent (SE) Device Description… | 2005 |
What descends from it? (10)
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 30 years and passes through 5 companies; a new generation was cleared every 5.7 years on median.
- 2 of the 8 ancestors have a recall of any class.
- Of its descendants, K102762 (Orthocon, Inc., 2011) has gone furthest, with 9 descendants of its own.
- 6 other devices also cite its predicate K043260.
How does its category compare?
All MTJ devicesMTJ Wax, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
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?
Orthocon OrthostatTM 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/K091121 · printed Nov 6, 2026
Cite this page
510(k) Report. “K091121: Orthostat.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K091121
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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