510(k) · Cleared
ClearedOsteoSeal Bone Hemostat
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hemostasis, LLC · MTJ Wax, Bone
Cleared on Jan 23, 2015 as substantially equivalent to K111538 (Skeletal Kinetics, LLC, 2011) and 3 other predicates after a 154-day review. Its family tree reaches back 9 generations to 1979. 1 of the 23 devices in its family, counting itself, has a Class I recall.
- Decided
- Jan 23, 2015
- Review
- 154 days
- Class
- Class U
- Product code
- MTJ
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 9 generations to K791495 (1979). 22 ancestors in all. No later device cites it as a predicate yet. 1 of the 23 devices in this family, counting this one, has a Class I recall.
- Root · 9 generations backK791495 Lukens Bone Wax (Gamma Radiation)Lukens Corp. · 1979
- 5 generations between
- 3 generations backK070093 Ostene, Aoc, Osteotene, Ceretene, Cerepor, Aptene, Apatene, ActipasteCeremed, Inc. · 2007
- 2 generations backK082491 Ostene CT Soluble Bone Hemostasis Implant Material, Aoc CT, Aoc…Ceremed, Inc. · 2008
- 1 generation backK113079 Synthes Hemostatic Bone PuttySynthes (Usa) Products, LLC/Norian Corporation · 2011 · Recalled (Class I)
- This deviceK142348 OsteoSeal Bone HemostatHemostasis, LLC · 2015
Show all 9 generations
- Root · 9 generations backK791495 Lukens Bone Wax (Gamma Radiation)Lukens Corp. · 1979
- 8 generations backK971680 Auto Suture Bone WaxUnited States Surgical, A Division of Tyco Healthc · 1997
- 7 generations backK041363 Aoc Bone WaxCeremed, Inc. · 2004 · Recalled
- 6 generations backK050440 Aoc Bone Wax, Ostene, Osteotene, Orthoseal, Osteoseal, Ceretene…Ceremed, Inc. · 2005
- 5 generations backK052528 Aoc Bone Wax Ostene, Osteotene and CereteneCeremed, Inc. · 2005
- 4 generations backK062280 Ostene, Aoc, Osteotene, Ceretene, Cerepor, Aptene, Apatene and…Ceremed, Inc. · 2006
- 3 generations backK070093 Ostene, Aoc, Osteotene, Ceretene, Cerepor, Aptene, Apatene, ActipasteCeremed, Inc. · 2007
- 2 generations backK082491 Ostene CT Soluble Bone Hemostasis Implant Material, Aoc CT, Aoc…Ceremed, Inc. · 2008
- 1 generation backK113079 Synthes Hemostatic Bone PuttySynthes (Usa) Products, LLC/Norian Corporation · 2011 · Recalled (Class I)
- This deviceK142348 OsteoSeal Bone HemostatHemostasis, LLC · 2015
Class I recalls in this family
- K113079 Synthes Hemostatic Bone Puttydirect predicate · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K791495 | Lukens Bone Wax (Gamma Radiation) | Lukens Corp. | 1979 | — |
| −8 | K971680 | Auto Suture Bone Wax | United States Surgical, A Division of Tyco Healthc | 1997 | — |
| −7 | K041363 | Aoc Bone Wax | Ceremed, Inc. | 2004 | 1 |
| −6 | K050440 | Aoc Bone Wax, Ostene, Osteotene, Orthoseal, Osteoseal, Ceretene, Model BW-12 | Ceremed, Inc. | 2005 | — |
| −5 | K052528 | Aoc Bone Wax Ostene, Osteotene and Ceretene | Ceremed, Inc. | 2005 | — |
| −4 | K062280 | Ostene, Aoc, Osteotene, Ceretene, Cerepor, Aptene, Apatene and Actipaste | Ceremed, Inc. | 2006 | — |
| −3 | K070093 | Ostene, Aoc, Osteotene, Ceretene, Cerepor, Aptene, Apatene, Actipaste | Ceremed, Inc. | 2007 | — |
| −2 | K082491 | Ostene CT Soluble Bone Hemostasis Implant Material, Aoc CT, Aoc, Ostene… | Ceremed, Inc. | 2008 | — |
| −1 | K113079 | Synthes Hemostatic Bone Putty | Synthes (Usa) Products, LLC/Norian Corporation | 2011 | Class I |
| 0 (this device) | K142348 | OsteoSeal Bone Hemostat | Hemostasis, LLC | 2015 | — |
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 | 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.
1 device in this family has a Class I recall. 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 6…48 page 2 of 2 Substantial Equivalence: OsteoSeal® Bone Hemostat is substantially equivalent to the following predicate devices: • Skeletal Kinetics CAAP Bone Wax K111538 • Synthes Hemostatic Bone Putty K113079 • Orthocon Orthostat Hemostatic Bone Putty/Applicator K091121/K102762 • Ethicon… | 2011 |
| * | K113079 | Synthes Hemostatic Bone PuttySummary page 6…OsteoSeal® Bone Hemostat is substantially equivalent to the following predicate devices: • Skeletal Kinetics CAAP Bone Wax K111538 • Synthes Hemostatic Bone Putty K113079 • Orthocon Orthostat Hemostatic Bone Putty/Applicator K091121/K102762 • Ethicon Bone Wax Preamendment Biocompatibility: Bi… | 2011 |
| * | K091121 | OrthostatSummary page 6…owing predicate devices: • Skeletal Kinetics CAAP Bone Wax K111538 • Synthes Hemostatic Bone Putty K113079 • Orthocon Orthostat Hemostatic Bone Putty/Applicator K091121/K102762 • Ethicon Bone Wax Preamendment Biocompatibility: Biocompatibility testing was performed using ISO 10993 – Biological… | 2009 |
| * | K102762 | Orthostat Bone Hemostat Matrix ApplicatorSummary page 6…edicate devices: • Skeletal Kinetics CAAP Bone Wax K111538 • Synthes Hemostatic Bone Putty K113079 • Orthocon Orthostat Hemostatic Bone Putty/Applicator K091121/K102762 • Ethicon Bone Wax Preamendment Biocompatibility: Biocompatibility testing was performed using ISO 10993 – Biological Evaluat… | 2011 |
| * | — | Ethicon Bone Wax Preamendment Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K113079Synthes Hemostatic Bone PuttySynthes (Usa) Products, LLC/Norian Corporation · 2011 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 36 years and passes through 5 companies; a new generation was cleared every 1.7 years on median.
- 5 of the 22 ancestors have a recall of any class; 1 has a Class I recall.
- 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. 2015, 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?
OsteoSeal® Bone Hemostat is indicated for use in the control of bleeding from cut or damaged bone surfaces by acting as a mechanical barrier. The material may be used during surgical procedures or in treating traumatic injuries. OsteoSeal® Bone Hemostat is intended for use under the direction of a licensed healthcare provider.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142348 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142348: OsteoSeal Bone Hemostat.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142348
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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