510(k) · Cleared
ClearedCP Medical Bone Wax
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cp Medical · MTJ Wax, Bone
Cleared on Jun 19, 2003 as substantially equivalent to K791495 (Lukens Corp., 1979) and 1 other predicate after a 170-day review. Its family tree reaches back 2 generations to 1979. 29 later devices descend from it.
- Decided
- Jun 19, 2003
- Review
- 170 days
- Class
- Class U
- Product code
- MTJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K791495 (1979). 29 later devices descend from it, 6 citing it directly.
- Root · 2 generations backK791495 Lukens Bone Wax (Gamma Radiation)Lukens Corp. · 1979
- 1 generation backK971680 Auto Suture Bone WaxUnited States Surgical, A Division of Tyco Healthc · 1997
- This deviceK024372 CP Medical Bone WaxCp Medical · 2003
- Descendant · cites it directly · 16 of its ownK123243 Hemasorb Bone Putty 3 Resorbable Hemostatic Bone PuttyOrthocon, Inc. · 2013
- Descendant · cites it directly · 14 of its ownK043260 Orthocon LLC Orthostat Hemostatic Bone PuttyOrthocon, LLC · 2005
- Descendant · cites it directly · 13 of its ownK141502 HBP4 Hardening, Resorbable Hemostatic Bone PuttyOrthocon, Inc. · 2014
- Descendant · 2 generations on · 12 of its ownK152005 MONTAGE Settable, Resorbable Hemostatic Bone PuttyOrthocon, Inc. · 2015
- Descendant · 2 generations on · 10 of its ownK091121 OrthostatOrthocon, Inc. · 2009
Showing 5 of 29 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 29 · See all- K123243Hemasorb Bone Putty 3 Resorbable Hemostatic Bone PuttyOrthocon, Inc. · 2013 · cites it directly16descendants
- K043260Orthocon LLC Orthostat Hemostatic Bone PuttyOrthocon, LLC · 2005 · cites it directly14descendants
- K141502HBP4 Hardening, Resorbable Hemostatic Bone PuttyOrthocon, Inc. · 2014 · cites it directly13descendants
- K152005MONTAGE Settable, Resorbable Hemostatic Bone PuttyOrthocon, Inc. · 2015 · 2 generations on12descendants
- K091121OrthostatOrthocon, Inc. · 2009 · 2 generations on10descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K791495 | Lukens Bone Wax (Gamma Radiation) | Lukens Corp. | 1979 | — |
| −1 | K971680 | Auto Suture Bone Wax | United States Surgical, A Division of Tyco Healthc | 1997 | — |
| 0 (this device) | K024372 | CP Medical Bone Wax | Cp Medical | 2003 | — |
| +1 | K123243 | Hemasorb Bone Putty 3 Resorbable Hemostatic Bone Putty | Orthocon, Inc. | 2013 | — |
| +1 | K043260 | Orthocon LLC Orthostat Hemostatic Bone Putty | Orthocon, LLC | 2005 | — |
| +1 | K141502 | HBP4 Hardening, Resorbable Hemostatic Bone Putty | Orthocon, Inc. | 2014 | — |
| +2 | K152005 | MONTAGE Settable, Resorbable Hemostatic Bone Putty | Orthocon, Inc. | 2015 | — |
| +2 | K091121 | Orthostat | Orthocon, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2009 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 3 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 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.
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 15.6 · 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 |
|---|---|---|---|
| * | K791495 | Lukens Bone Wax (Gamma Radiation)Summary page 1…evices: The proposed device is substantially equivalent to other legally marketed bone waxes, including Ethicon Bove Wax (Preamendment, Ethicon, Inc.), Lukens Bone Wax (K791495, Lukens Medical Corporation), and Auto Suture® Bone Wax (K971680, United States Surgical). Indications: The CP Medical Bone Wax… | 1979 |
| * | K971680 | Auto Suture Bone WaxSummary page 1…legally marketed bone waxes, including Ethicon Bove Wax (Preamendment, Ethicon, Inc.), Lukens Bone Wax (K791495, Lukens Medical Corporation), and Auto Suture® Bone Wax (K971680, United States Surgical). Indications: The CP Medical Bone Wax is indjcated for use in the contro] of bleeding from bone surface… | 1997 |
| * | — | Ethicon Bone Wax Named without a submission number |
What descends from it? (29)
See all 296 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| 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 |
| K202363 | HBP7 Settable Hemostatic Bone Putty | 2021 | 2 |
| K200452 | Meril-Bonewax | 2023 | 0 |
| K060987 | OSCERA7 Synthetic Absorbable Bone Wax, Model OS31 | 2006 | 0 |
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 24 years and passes through 3 companies; a new generation was cleared every 18.1 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K123243 (Orthocon, Inc., 2013) has gone furthest, with 16 descendants of its own.
- 4 other devices also cite its predicate K791495.
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?
The CP Medical 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/K024372 · printed Nov 3, 2026
Cite this page
510(k) Report. “K024372: CP Medical Bone Wax.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K024372
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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