510(k) · Cleared
ClearedHBP4 Hardening, 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 Oct 3, 2014 as substantially equivalent to K111538 (Skeletal Kinetics, LLC, 2011) and 4 other predicates after a 119-day review. Its family tree reaches back 10 generations to 1979. 13 later devices descend from it.
- Decided
- Oct 3, 2014
- Review
- 119 days
- Class
- Class U
- Product code
- MTJ
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 10 generations to K791495 (1979). 18 ancestors in all. 13 later devices descend from it, 4 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 deviceK141502 HBP4 Hardening, Resorbable Hemostatic Bone PuttyOrthocon, Inc. · 2014
- Descendant · cites it directly · 12 of its ownK152005 MONTAGE Settable, Resorbable Hemostatic Bone PuttyOrthocon, Inc. · 2015
- Descendant · 2 generations on · 3 of its ownK213418 MONTAGE Settable, Resorbable Hemostatic Bone PuttyOrthocon, Inc. · 2023
- Descendant · 2 generations on · 3 of its ownK191140 MONTAGE-QS Settable, Resorbable Hemostatic BoneOrthocon, Inc. · 2019
- Descendant · cites it directly · 2 of its ownK202363 HBP7 Settable Hemostatic Bone PuttyOrthocon, Inc. · 2021
- Descendant · cites it directly · 1 of its ownK242050 Montage Settable Bone PuttyOrthocon, Inc. · 2024
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 deviceK141502 HBP4 Hardening, Resorbable Hemostatic Bone PuttyOrthocon, Inc. · 2014
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K152005MONTAGE Settable, Resorbable Hemostatic Bone PuttyOrthocon, Inc. · 2015 · cites it directly12descendants
- K213418MONTAGE Settable, Resorbable Hemostatic Bone PuttyOrthocon, Inc. · 2023 · 2 generations on3descendants
- K191140MONTAGE-QS Settable, Resorbable Hemostatic BoneOrthocon, Inc. · 2019 · 2 generations on3descendants
- K202363HBP7 Settable Hemostatic Bone PuttyOrthocon, Inc. · 2021 · cites it directly2descendants
- K242050Montage Settable Bone PuttyOrthocon, Inc. · 2024 · cites it directly1descendant
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) | K141502 | HBP4 Hardening, Resorbable Hemostatic Bone Putty | Orthocon, Inc. | 2014 | — |
| +1 | K152005 | MONTAGE Settable, Resorbable Hemostatic Bone Putty | Orthocon, Inc. | 2015 | — |
| +2 | K213418 | MONTAGE Settable, Resorbable Hemostatic Bone Putty | Orthocon, Inc. | 2023 | — |
| +2 | K191140 | MONTAGE-QS Settable, Resorbable Hemostatic Bone | Orthocon, Inc. | 2019 | — |
| +1 | K202363 | HBP7 Settable Hemostatic Bone Putty | Orthocon, Inc. | 2021 | — |
| +1 | K242050 | Montage Settable Bone Putty | Orthocon, Inc. | 2024 | — |
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 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 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? (5)
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 |
|---|---|---|---|
| * | K111538 | Skaffold CisSummary page 4…fication: Unclassified Product Code: MTJ Primary Predicate: Skeletal Kinetics CAAP (Calcium Apatite) Bone Wax 510(k) K111538 Additional predicates: US Surgical Auto Suture Bone Wax 510(k) K971680 CP M… | 2011 |
| * | K971680 | Auto Suture Bone WaxSummary page 4…netics CAAP (Calcium Apatite) Bone Wax 510(k) K111538 Additional predicates: US Surgical Auto Suture Bone Wax 510(k) K971680 CP Medical Bone Wax 510(k) K024372 Ceremed Ostene® C… | 1997 |
| * | K024372 | CP Medical Bone WaxSummary page 4…onal predicates: US Surgical Auto Suture Bone Wax 510(k) K971680 CP Medical Bone Wax 510(k) K024372 Ceremed Ostene® CT Bone Hemostasis Implant 510(k) K102071… | 2003 |
| * | K102071 | Ostene CT, Aoc CT, Osteotene, CereteneSummary page 4…CP Medical Bone Wax 510(k) K024372 Ceremed Ostene® CT Bone Hemostasis Implant 510(k) K102071 Orthocon Hemostatic Bone Putty 3 510(k) K123243… | 2010 |
| * | K123243 | Hemasorb Bone Putty 3 Resorbable Hemostatic Bone PuttySummary page 4…med Ostene® CT Bone Hemostasis Implant 510(k) K102071 Orthocon Hemostatic Bone Putty 3 510(k) K123243 1… | 2013 |
What descends from it? (13)
See all 134 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 35 years and passes through 4 companies; a new generation was cleared every 1.3 years on median.
- 3 of the 18 ancestors have a recall of any class.
- Of its descendants, K152005 (Orthocon, Inc., 2015) has gone furthest, with 12 descendants of its own.
- 2 other devices also cite its predicate K111538.
How does its category compare?
All MTJ devicesMTJ Wax, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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?
HBP4 Hardening, 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/K141502 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141502: HBP4 Hardening, 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/K141502
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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