510(k) · Cleared
ClearedHemasorb Bone Putty 3 Resorbable Hemostatic Bone Putty
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 5, 2013 as substantially equivalent to K041363 (Ceremed, Inc., 2004) and 3 other predicates after a 170-day review. Its family tree reaches back 7 generations to 1979. 16 later devices descend from it.
- Decided
- Apr 5, 2013
- Review
- 170 days
- Class
- Class U
- Product code
- MTJ
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 7 generations to K791495 (1979). 13 ancestors in all. 16 later devices descend from it, 3 citing it directly.
- Root · 7 generations backK791495 Lukens Bone Wax (Gamma Radiation)Lukens Corp. · 1979
- 6 generations backK971680 Auto Suture Bone WaxUnited States Surgical, A Division of Tyco Healthc · 1997
- 5 generations backK041363 Aoc Bone WaxCeremed, Inc. · 2004 · Recalled
- 4 generations backK050440 Aoc Bone Wax, Ostene, Osteotene, Orthoseal, Osteoseal, Ceretene…Ceremed, Inc. · 2005
- 3 generations backK052528 Aoc Bone Wax Ostene, Osteotene and CereteneCeremed, Inc. · 2005
- 2 generations backK062280 Ostene, Aoc, Osteotene, Ceretene, Cerepor, Aptene, Apatene and…Ceremed, Inc. · 2006
- 1 generation backK111538 Skaffold CisSkeletal Kinetics, LLC · 2011
- This deviceK123243 Hemasorb Bone Putty 3 Resorbable Hemostatic Bone PuttyOrthocon, Inc. · 2013
- Descendant · cites it directly · 13 of its ownK141502 HBP4 Hardening, Resorbable Hemostatic Bone PuttyOrthocon, Inc. · 2014
- Descendant · 2 generations on · 12 of its ownK152005 MONTAGE Settable, Resorbable Hemostatic Bone PuttyOrthocon, Inc. · 2015
- Descendant · 3 generations on · 3 of its ownK213418 MONTAGE Settable, Resorbable Hemostatic Bone PuttyOrthocon, Inc. · 2023
- Descendant · 3 generations on · 3 of its ownK191140 MONTAGE-QS Settable, Resorbable Hemostatic BoneOrthocon, Inc. · 2019
- Descendant · 2 generations on · 2 of its ownK202363 HBP7 Settable Hemostatic Bone PuttyOrthocon, Inc. · 2021
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K141502HBP4 Hardening, Resorbable Hemostatic Bone PuttyOrthocon, Inc. · 2014 · cites it directly13descendants
- K152005MONTAGE Settable, Resorbable Hemostatic Bone PuttyOrthocon, Inc. · 2015 · 2 generations on12descendants
- K213418MONTAGE Settable, Resorbable Hemostatic Bone PuttyOrthocon, Inc. · 2023 · 3 generations on3descendants
- K191140MONTAGE-QS Settable, Resorbable Hemostatic BoneOrthocon, Inc. · 2019 · 3 generations on3descendants
- K202363HBP7 Settable Hemostatic Bone PuttyOrthocon, Inc. · 2021 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K791495 | Lukens Bone Wax (Gamma Radiation) | Lukens Corp. | 1979 | — |
| −6 | K971680 | Auto Suture Bone Wax | United States Surgical, A Division of Tyco Healthc | 1997 | — |
| −5 | K041363 | Aoc Bone Wax | Ceremed, Inc. | 2004 | 1 |
| −4 | K050440 | Aoc Bone Wax, Ostene, Osteotene, Orthoseal, Osteoseal, Ceretene, Model BW-12 | Ceremed, Inc. | 2005 | — |
| −3 | K052528 | Aoc Bone Wax Ostene, Osteotene and Ceretene | Ceremed, Inc. | 2005 | — |
| −2 | K062280 | Ostene, Aoc, Osteotene, Ceretene, Cerepor, Aptene, Apatene and Actipaste | Ceremed, Inc. | 2006 | — |
| −1 | K111538 | Skaffold Cis | Skeletal Kinetics, LLC | 2011 | — |
| 0 (this device) | K123243 | Hemasorb Bone Putty 3 Resorbable Hemostatic Bone Putty | Orthocon, Inc. | 2013 | — |
| +1 | K141502 | HBP4 Hardening, Resorbable Hemostatic Bone Putty | Orthocon, Inc. | 2014 | — |
| +2 | K152005 | MONTAGE Settable, Resorbable Hemostatic Bone Putty | Orthocon, Inc. | 2015 | — |
| +3 | K213418 | MONTAGE Settable, Resorbable Hemostatic Bone Putty | Orthocon, Inc. | 2023 | — |
| +3 | K191140 | MONTAGE-QS Settable, Resorbable Hemostatic Bone | Orthocon, Inc. | 2019 | — |
| +2 | K202363 | HBP7 Settable Hemostatic Bone Putty | Orthocon, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 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.
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 |
|---|---|---|---|
| * | K041363 | Aoc Bone WaxSummary page 2…ubstantial Equivalence and Predicate Devices: The device was shown to be substantially equivalent to previously cleared bone wax devices including Ostene®D AOC Bone Wax (K04 1363), US Surgical Auto Suture Bone Wax (K971680), and Skeletal Kinetics CAAP (Calcium Apatite) Bone Wax (KI 11538), and traditional n… | 2004 |
| * | K971680 | Auto Suture Bone WaxSummary page 2…The device was shown to be substantially equivalent to previously cleared bone wax devices including Ostene®D AOC Bone Wax (K04 1363), US Surgical Auto Suture Bone Wax (K971680), and Skeletal Kinetics CAAP (Calcium Apatite) Bone Wax (KI 11538), and traditional nonabsorbable bone wax devices, including C?… | 1997 |
| * | K111538 | Skaffold Cis | 2011 |
| * | K024372 | CP Medical Bone WaxSummary page 2…ture Bone Wax (K971680), and Skeletal Kinetics CAAP (Calcium Apatite) Bone Wax (KI 11538), and traditional nonabsorbable bone wax devices, including C? Medical Bone Wax (K024372). Performance Testing: Bench testingi biocompatibility and animal functionality testing performed on the HEMOSTATIC BONE PUTTY 3… | 2003 |
What descends from it? (16)
See all 163 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 34 years and passes through 5 companies; a new generation was cleared every 1.4 years on median.
- 3 of the 13 ancestors have a recall of any class.
- Of its descendants, K141502 (Orthocon, Inc., 2014) has gone furthest, with 13 descendants of its own.
- 6 other devices also cite its predicate K041363.
How does its category compare?
All MTJ devicesMTJ Wax, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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?
HEMOSTATIC BONE PUTTY 3 Resorbable Hemostatic Bone Putty is indicated for the control of bleeding from cut or damaged bone by acting as a mechanical barrier or tamponade.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123243 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123243: Hemasorb Bone Putty 3 Resorbable 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/K123243
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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