510(k) · Cleared
Recalled · Class I · 2012Synthes Hemostatic Bone Putty (HBP)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes USA Products, LLC · MTJ Wax, Bone
Cleared on May 19, 2011 as substantially equivalent to K082491 (Ceremed, Inc., 2008) after a 140-day review. Its family tree reaches back 8 generations to 1979. 1 of the 14 devices in its family, counting itself, has a Class I recall. It has been recalled once, including a Class I recall.
- Decided
- May 19, 2011
- Review
- 140 days
- Class
- Class U
- Product code
- MTJ
- Recalls
- 1 (1 Class I)
- Predicates
- 1
Its longest line of descent runs back 8 generations to K791495 (1979). 13 ancestors in all. No later device cites it as a predicate yet. 1 of the 14 devices in this family, counting this one, has a Class I recall.
- Root · 8 generations backK791495 Lukens Bone Wax (Gamma Radiation)Lukens Corp. · 1979
- 7 generations backK971680 Auto Suture Bone WaxUnited States Surgical, A Division of Tyco Healthc · 1997
- 6 generations backK041363 Aoc Bone WaxCeremed, Inc. · 2004 · Recalled
- 5 generations backK050440 Aoc Bone Wax, Ostene, Osteotene, Orthoseal, Osteoseal, Ceretene…Ceremed, Inc. · 2005
- 4 generations backK052528 Aoc Bone Wax Ostene, Osteotene and CereteneCeremed, Inc. · 2005
- 3 generations backK062280 Ostene, Aoc, Osteotene, Ceretene, Cerepor, Aptene, Apatene and…Ceremed, Inc. · 2006
- 2 generations backK070093 Ostene, Aoc, Osteotene, Ceretene, Cerepor, Aptene, Apatene, ActipasteCeremed, Inc. · 2007
- 1 generation backK082491 Ostene CT Soluble Bone Hemostasis Implant Material, Aoc CT, Aoc…Ceremed, Inc. · 2008
- This deviceK103822 Synthes Hemostatic Bone Putty (HBP)Synthes USA Products, LLC · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K791495 | Lukens Bone Wax (Gamma Radiation) | Lukens Corp. | 1979 | — |
| −7 | K971680 | Auto Suture Bone Wax | United States Surgical, A Division of Tyco Healthc | 1997 | — |
| −6 | K041363 | Aoc Bone Wax | Ceremed, Inc. | 2004 | 1 |
| −5 | K050440 | Aoc Bone Wax, Ostene, Osteotene, Orthoseal, Osteoseal, Ceretene, Model BW-12 | Ceremed, Inc. | 2005 | — |
| −4 | K052528 | Aoc Bone Wax Ostene, Osteotene and Ceretene | Ceremed, Inc. | 2005 | — |
| −3 | K062280 | Ostene, Aoc, Osteotene, Ceretene, Cerepor, Aptene, Apatene and Actipaste | Ceremed, Inc. | 2006 | — |
| −2 | K070093 | Ostene, Aoc, Osteotene, Ceretene, Cerepor, Aptene, Apatene, Actipaste | Ceremed, Inc. | 2007 | — |
| −1 | K082491 | Ostene CT Soluble Bone Hemostasis Implant Material, Aoc CT, Aoc, Ostene… | Ceremed, Inc. | 2008 | — |
| 0 (this device) | K103822 | Synthes Hemostatic Bone Putty (HBP) | Synthes USA Products, LLC | 2011 | — |
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 |
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? (1)
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 |
|---|---|---|---|
| * | K082491 | Ostene CT Soluble Bone Hemostasis Implant Material, Aoc CT, Aoc, Ostene, Osteotene &…Summary page 1…ssified Product Code MTJ Predicate Ceremed, Inc. Devices: Ostene CT Soluble Hemostasis Implant Material K082491 Device Synthes Hemostatic Bone Putty (HBP) stops bone bleeding Description: by establishing a physica… | 2008 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 5, 2012 | Class I | Z-2206-2012 | Labeling design | There is the potential for Hemostatic Bone Putty to ignite if contacted with electrosurgical cautery systems under certain conditions during surgery. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 32 years and passes through 4 companies; a new generation was cleared every 1.7 years on median.
- 3 of the 13 ancestors have a recall of any class.
- 3 other devices also cite its predicate K082491.
How does its category compare?
All MTJ devicesMTJ Wax, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?
Synthes Hemostatic Bone Putty is indicated for use as a water-soluble implant material and for use in the control of bleeding from bone surfaces.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K103822 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103822: Synthes Hemostatic Bone Putty (HBP).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103822
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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