510(k) · Cleared
ClearedHemasorb Absorbable Bone Hemostat Matrix
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orthocon, Inc. · MTJ Wax, Bone
Cleared on May 23, 2012 as substantially equivalent to K043260 (Orthocon, LLC, 2005) and 3 other predicates after a 352-day review. Its family tree reaches back 10 generations to 1979. 6 later devices descend from it.
- Decided
- May 23, 2012
- Review
- 352 days
- Class
- Class U
- Product code
- MTJ
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 10 generations to K791495 (1979). 22 ancestors in all. 6 later devices descend from it, 3 citing it directly.
- Root · 10 generations backK791495 Lukens Bone Wax (Gamma Radiation)Lukens Corp. · 1979
- 6 generations between
- 3 generations backK082491 Ostene CT Soluble Bone Hemostasis Implant Material, Aoc CT, Aoc…Ceremed, Inc. · 2008
- 2 generations backK091636 Ostene CT, Aoc CT, Osteotene, CereteneCeremed, Inc. · 2009
- 1 generation backK102071 Ostene CT, Aoc CT, Osteotene, CereteneCeremed, Inc. · 2010
- This deviceK111575 Hemasorb Absorbable Bone Hemostat MatrixOrthocon, Inc. · 2012
- Descendant · cites it directly · 3 of its ownK213418 MONTAGE Settable, Resorbable Hemostatic Bone PuttyOrthocon, Inc. · 2023
- Descendant · 2 generations on · 1 of its ownK242050 Montage Settable Bone PuttyOrthocon, Inc. · 2024
- Descendant · 2 generations on · 1 of its ownK232998 Montage- XT Settable, Resorbable Hemostatic Bone PuttyOrthocon, Inc. · 2023
- Descendant · 3 generations on · 0 of its ownK243506 Montage-XT Settable Bone PuttyOrthocon, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK142339 HEMASORB Resorbable Hemostatic Bone PuttyOrthocon, LLC · 2014
Show all 10 generations
- Root · 10 generations backK791495 Lukens Bone Wax (Gamma Radiation)Lukens Corp. · 1979
- 9 generations backK971680 Auto Suture Bone WaxUnited States Surgical, A Division of Tyco Healthc · 1997
- 8 generations backK041363 Aoc Bone WaxCeremed, Inc. · 2004 · Recalled
- 7 generations backK050440 Aoc Bone Wax, Ostene, Osteotene, Orthoseal, Osteoseal, Ceretene…Ceremed, Inc. · 2005
- 6 generations backK052528 Aoc Bone Wax Ostene, Osteotene and CereteneCeremed, Inc. · 2005
- 5 generations backK062280 Ostene, Aoc, Osteotene, Ceretene, Cerepor, Aptene, Apatene and…Ceremed, Inc. · 2006
- 4 generations backK070093 Ostene, Aoc, Osteotene, Ceretene, Cerepor, Aptene, Apatene, ActipasteCeremed, Inc. · 2007
- 3 generations backK082491 Ostene CT Soluble Bone Hemostasis Implant Material, Aoc CT, Aoc…Ceremed, Inc. · 2008
- 2 generations backK091636 Ostene CT, Aoc CT, Osteotene, CereteneCeremed, Inc. · 2009
- 1 generation backK102071 Ostene CT, Aoc CT, Osteotene, CereteneCeremed, Inc. · 2010
- This deviceK111575 Hemasorb Absorbable Bone Hemostat MatrixOrthocon, Inc. · 2012
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K213418MONTAGE Settable, Resorbable Hemostatic Bone PuttyOrthocon, Inc. · 2023 · cites it directly3descendants
- K242050Montage Settable Bone PuttyOrthocon, Inc. · 2024 · 2 generations on1descendant
- K232998Montage- XT Settable, Resorbable Hemostatic Bone PuttyOrthocon, Inc. · 2023 · 2 generations on1descendant
- K243506Montage-XT Settable Bone PuttyOrthocon, Inc. · 2024 · 3 generations on0descendants
- K142339HEMASORB Resorbable Hemostatic Bone PuttyOrthocon, LLC · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K791495 | Lukens Bone Wax (Gamma Radiation) | Lukens Corp. | 1979 | — |
| −9 | K971680 | Auto Suture Bone Wax | United States Surgical, A Division of Tyco Healthc | 1997 | — |
| −8 | K041363 | Aoc Bone Wax | Ceremed, Inc. | 2004 | 1 |
| −7 | K050440 | Aoc Bone Wax, Ostene, Osteotene, Orthoseal, Osteoseal, Ceretene, Model BW-12 | Ceremed, Inc. | 2005 | — |
| −6 | K052528 | Aoc Bone Wax Ostene, Osteotene and Ceretene | Ceremed, Inc. | 2005 | — |
| −5 | K062280 | Ostene, Aoc, Osteotene, Ceretene, Cerepor, Aptene, Apatene and Actipaste | Ceremed, Inc. | 2006 | — |
| −4 | K070093 | Ostene, Aoc, Osteotene, Ceretene, Cerepor, Aptene, Apatene, Actipaste | Ceremed, Inc. | 2007 | — |
| −3 | K082491 | Ostene CT Soluble Bone Hemostasis Implant Material, Aoc CT, Aoc, Ostene… | Ceremed, Inc. | 2008 | — |
| −2 | K091636 | Ostene CT, Aoc CT, Osteotene, Ceretene | Ceremed, Inc. | 2009 | — |
| −1 | K102071 | Ostene CT, Aoc CT, Osteotene, Ceretene | Ceremed, Inc. | 2010 | — |
| 0 (this device) | K111575 | Hemasorb Absorbable Bone Hemostat Matrix | Orthocon, Inc. | 2012 | — |
| +1 | K213418 | MONTAGE Settable, Resorbable Hemostatic Bone Putty | Orthocon, Inc. | 2023 | — |
| +2 | K242050 | Montage Settable Bone Putty | Orthocon, Inc. | 2024 | — |
| +2 | K232998 | Montage- XT Settable, Resorbable Hemostatic Bone Putty | Orthocon, Inc. | 2023 | — |
| +3 | K243506 | Montage-XT Settable Bone Putty | Orthocon, Inc. | 2024 | — |
| +1 | K142339 | HEMASORB Resorbable Hemostatic Bone Putty | Orthocon, LLC | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1996 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 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? (4)
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 2…be dispersed and substantially absorbed within a period of 30 days. Predicate Devices: Hemasorb was shown to be substantially equivalent to previously cleared devices (K043260, K091 121, K102762, and K102071). Substantial Equivalence: Hemasorb Resorbable Hemostatic Bone Putty is substantially equivalent… | 2005 |
| * | K091121 | OrthostatSummary page 2…rsed and substantially absorbed within a period of 30 days. Predicate Devices: Hemasorb was shown to be substantially equivalent to previously cleared devices (K043260, K091 121, K102762, and K102071). Substantial Equivalence: Hemasorb Resorbable Hemostatic Bone Putty is substantially equivalent to predic… | 2009 |
| * | K102762 | Orthostat Bone Hemostat Matrix ApplicatorSummary page 2…ubstantially absorbed within a period of 30 days. Predicate Devices: Hemasorb was shown to be substantially equivalent to previously cleared devices (K043260, K091 121, K102762, and K102071). Substantial Equivalence: Hemasorb Resorbable Hemostatic Bone Putty is substantially equivalent to predicate devic… | 2011 |
| * | K102071 | Ostene CT, Aoc CT, Osteotene, CereteneSummary page 2…absorbed within a period of 30 days. Predicate Devices: Hemasorb was shown to be substantially equivalent to previously cleared devices (K043260, K091 121, K102762, and K102071). Substantial Equivalence: Hemasorb Resorbable Hemostatic Bone Putty is substantially equivalent to predicate devices in indicat… | 2010 |
What descends from it? (6)
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 33 years and passes through 4 companies; a new generation was cleared every 1.3 years on median.
- 4 of the 22 ancestors have a recall of any class.
- Of its descendants, K213418 (Orthocon, Inc., 2023) has gone furthest, with 3 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. 2012, 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?
Hemasorb Resorbable 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. Hemasorb Resorbable Hemostatic Bone Putty is also indicated for use in the control of bleeding from bone surfaces in cardiothoracic surgery following sternotomy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111575 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111575: Hemasorb Absorbable Bone Hemostat Matrix.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111575
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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