510(k) · Cleared
ClearedOrthocon Absorbable 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 Jan 28, 2013 as substantially equivalent to K041363 (Ceremed, Inc., 2004) and 1 other predicate after a 192-day review. Its family tree reaches back 9 generations to 1979. 1 of the 18 devices in its family, counting itself, has a Class I recall. 3 later devices descend from it.
- Decided
- Jan 28, 2013
- Review
- 192 days
- Class
- Class U
- Product code
- MTJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K791495 (1979). 14 ancestors in all. 3 later devices descend from it, 1 citing it directly. 1 of the 18 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 deviceK122156 Orthocon Absorbable Hemostatic Bone PuttyOrthocon, Inc. · 2013
- Descendant · cites it directly · 2 of its ownK140117 Ahbppress Absorbable Hemostatic Bone PuttyOrthocon, Inc. · 2014
- Descendant · 2 generations on · 0 of its ownK143069 HEMASORBPLUS press Resorable Hemostatic Bone PuttyOrthocon, Inc. · 2014
- Descendant · 2 generations on · 0 of its ownK142339 HEMASORB Resorbable Hemostatic Bone PuttyOrthocon, LLC · 2014
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 deviceK122156 Orthocon Absorbable Hemostatic Bone PuttyOrthocon, Inc. · 2013
Class I recalls in this family
- K113079 Synthes Hemostatic Bone Puttydirect predicate · 2011
Most influential descendants
Showing 3 of 3 · See all- K140117Ahbppress Absorbable Hemostatic Bone PuttyOrthocon, Inc. · 2014 · cites it directly2descendants
- K143069HEMASORBPLUS press Resorable Hemostatic Bone PuttyOrthocon, Inc. · 2014 · 2 generations on0descendants
- K142339HEMASORB Resorbable Hemostatic Bone PuttyOrthocon, LLC · 2014 · 2 generations on0descendants
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) | K122156 | Orthocon Absorbable Hemostatic Bone Putty | Orthocon, Inc. | 2013 | — |
| +1 | K140117 | Ahbppress Absorbable Hemostatic Bone Putty | Orthocon, Inc. | 2014 | — |
| +2 | K143069 | HEMASORBPLUS press Resorable Hemostatic Bone Putty | Orthocon, Inc. | 2014 | — |
| +2 | 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 |
| 2002 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 3 | 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 15.6 · 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? (3)
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 1…ication: Unclassified Product Code: MVTJ Predicate Devices Ceremed, Inc. Ostene AO Bone Wax K041363 and others Synthes (USA) Synthes Hemostatic Bone Putty K1 13079 a… | 2004 |
| * | K113079 | Synthes Hemostatic Bone PuttySummary page 1…Ostene AO Bone Wax K041363 and others Synthes (USA) Synthes Hemostatic Bone Putty K1 13079 and others Ethicon, Inc. Ethicon Bone Wax pre-amendment… | 2011 |
| * | — | Ethicon Bone Wax Named without a submission number |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K140117 | Ahbppress Absorbable Hemostatic Bone Putty | 2014 | 2 |
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 34 years and passes through 5 companies; a new generation was cleared every 1.2 years on median.
- 4 of the 14 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K140117 (Orthocon, Inc., 2014) has gone furthest, with 2 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?
Orthocon Absorbable Hemostatic Bone Putty is indicated for use as an absorbable implant material in the control of bleeding from bone surfaces.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122156 · printed Nov 4, 2026
Cite this page
510(k) Report. “K122156: Orthocon Absorbable Hemostatic Bone Putty.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K122156
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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