510(k) · Cleared
ClearedAuto Suture Bone Wax
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
United States Surgical, A Division of Tyco Healthc · MTJ Wax, Bone
Cleared on Oct 24, 1997 as substantially equivalent to K791495 (Lukens Corp., 1979) after a 170-day review. Its family tree reaches back 1 generation to 1979. 2 of the 57 devices in its family, counting itself, have a Class I recall. 55 later devices descend from it.
- Decided
- Oct 24, 1997
- Review
- 170 days
- Class
- Class U
- Product code
- MTJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K791495 (1979). 55 later devices descend from it, 8 citing it directly. 2 of the 57 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK791495 Lukens Bone Wax (Gamma Radiation)Lukens Corp. · 1979
- This deviceK971680 Auto Suture Bone WaxUnited States Surgical, A Division of Tyco Healthc · 1997
- Descendant · cites it directly · 52 of its ownK041363 Aoc Bone WaxCeremed, Inc. · 2004 · Recalled
- Descendant · 2 generations on · 43 of its ownK043133 Aoc Porous Polyethylene, Aoc Porous Hdpe, Aoc Porous Polyethylene…Ceremed, Inc. · 2005
- Descendant · 2 generations on · 40 of its ownK050440 Aoc Bone Wax, Ostene, Osteotene, Orthoseal, Osteoseal, Ceretene…Ceremed, Inc. · 2005
- Descendant · 2 generations on · 39 of its ownK052528 Aoc Bone Wax Ostene, Osteotene and CereteneCeremed, Inc. · 2005
- Descendant · 2 generations on · 38 of its ownK062280 Ostene, Aoc, Osteotene, Ceretene, Cerepor, Aptene, Apatene and…Ceremed, Inc. · 2006
Showing 5 of 55 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 55 · See all- K041363Aoc Bone WaxCeremed, Inc. · 2004 · cites it directly52descendants
- K043133Aoc Porous Polyethylene, Aoc Porous Hdpe, Aoc Porous Polyethylene Surgical Implant…Ceremed, Inc. · 2005 · 2 generations on43descendants
- K050440Aoc Bone Wax, Ostene, Osteotene, Orthoseal, Osteoseal, Ceretene, Model BW-12Ceremed, Inc. · 2005 · 2 generations on40descendants
- K052528Aoc Bone Wax Ostene, Osteotene and CereteneCeremed, Inc. · 2005 · 2 generations on39descendants
- K062280Ostene, Aoc, Osteotene, Ceretene, Cerepor, Aptene, Apatene and ActipasteCeremed, Inc. · 2006 · 2 generations on38descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K791495 | Lukens Bone Wax (Gamma Radiation) | Lukens Corp. | 1979 | — |
| 0 (this device) | K971680 | Auto Suture Bone Wax | United States Surgical, A Division of Tyco Healthc | 1997 | — |
| +1 | K041363 | Aoc Bone Wax | Ceremed, Inc. | 2004 | 1 |
| +2 | K043133 | Aoc Porous Polyethylene, Aoc Porous Hdpe, Aoc Porous Polyethylene Surgical… | Ceremed, Inc. | 2005 | — |
| +2 | K050440 | Aoc Bone Wax, Ostene, Osteotene, Orthoseal, Osteoseal, Ceretene, Model BW-12 | Ceremed, Inc. | 2005 | — |
| +2 | 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 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 4 | 0 |
| 2006 | 3 | 0 |
| 2007 | 1 | 0 |
| 2008 | 4 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 7 | 2 |
| 2012 | 5 | 0 |
| 2013 | 3 | 0 |
| 2014 | 5 | 0 |
| 2015 | 2 | 0 |
| 2016 | 3 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 5 | 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.
2 devices in this family have 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? (2)
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 |
|---|---|---|---|
| * | K791495 | Lukens Bone Wax (Gamma Radiation)Summary page 1…ver Avenue Norwalk, CT 06856 Melissa Mazzoni May 5, 1997 Unclassified Bone Wax Trademark name not yet determined Ethicon™ Bone Wax (preamendment) Lukens™ Bone Wax (K791495) Auto Suture* Bone Wax** is designed to control bleeding from bone surfaces by the creation of a mechanical barrier. Auto Sutur… | 1979 |
| * | — | Ethicon™ Bone Wax (preamendment) Named without a submission number |
What descends from it? (55)
See all 558 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K041363 | Aoc Bone Wax | 2004 | 52 |
| K024372 | CP Medical Bone Wax | 2003 | 29 |
| K111538 | Skaffold Cis | 2011 | 18 |
| K123243 | Hemasorb Bone Putty 3 Resorbable Hemostatic Bone Putty | 2013 | 16 |
| K043260 | Orthocon LLC Orthostat Hemostatic Bone Putty | 2005 | 14 |
| K141502 | HBP4 Hardening, Resorbable Hemostatic Bone Putty | 2014 | 13 |
| K111524 | MP 719 | 2011 | 0 |
| K060987 | OSCERA7 Synthetic Absorbable Bone Wax, Model OS31 | 2006 | 0 |
Has anything in its family been recalled? (2 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.
- K103822Synthes Hemostatic Bone Putty (HBP)Synthes USA Products, LLC · 2011 · 5 generations on · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
- K113079Synthes Hemostatic Bone PuttySynthes (Usa) Products, LLC/Norian Corporation · 2011 · 5 generations on · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
What does this lineage say?
How does its category compare?
All MTJ devicesMTJ Wax, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
Auto Suture* Bone Wax** is indicated 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/K971680 · printed Nov 6, 2026
Cite this page
510(k) Report. “K971680: Auto Suture Bone Wax.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K971680
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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