510(k) · Cleared
ClearedOSCERA7 Synthetic Absorbable Bone Wax, Model OS31
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cp Medical · MTJ Wax, Bone
Cleared on Nov 2, 2006 as substantially equivalent to K024372 (Cp Medical, 2003) and 2 other predicates after a 206-day review. Its family tree reaches back 4 generations to 1979.
- Decided
- Nov 2, 2006
- Review
- 206 days
- Class
- Class U
- Product code
- MTJ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K791495 (1979). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK791495 Lukens Bone Wax (Gamma Radiation)Lukens Corp. · 1979
- 3 generations backK971680 Auto Suture Bone WaxUnited States Surgical, A Division of Tyco Healthc · 1997
- 2 generations backK024372 CP Medical Bone WaxCp Medical · 2003
- 1 generation backK043260 Orthocon LLC Orthostat Hemostatic Bone PuttyOrthocon, LLC · 2005
- This deviceK060987 OSCERA7 Synthetic Absorbable Bone Wax, Model OS31Cp Medical · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K791495 | Lukens Bone Wax (Gamma Radiation) | Lukens Corp. | 1979 | — |
| −3 | K971680 | Auto Suture Bone Wax | United States Surgical, A Division of Tyco Healthc | 1997 | — |
| −2 | K024372 | CP Medical Bone Wax | Cp Medical | 2003 | — |
| −1 | K043260 | Orthocon LLC Orthostat Hemostatic Bone Putty | Orthocon, LLC | 2005 | — |
| 0 (this device) | K060987 | OSCERA7 Synthetic Absorbable Bone Wax, Model OS31 | Cp Medical | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2000 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 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.
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 15.5 · 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? (4)
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 |
|---|---|---|---|
| * | K024372 | CP Medical Bone WaxSummary page 1…odel Number: OS31 Classification Name: Bone Wax (MTJ) Device Classification: Unclassified Predicate Devices: CP Medical Bone Wax, K024372 Ethicon Bone Wax, (Pre-amendment) Orthostat Bone Putty, K043260… | 2003 |
| * | K043260 | Orthocon LLC Orthostat Hemostatic Bone PuttySummary page 1…e Devices: CP Medical Bone Wax, K024372 Ethicon Bone Wax, (Pre-amendment) Orthostat Bone Putty, K043260 Autosuture Bone Wax, K971680 Manufacturer. CP Medical… | 2005 |
| * | K971680 | Auto Suture Bone WaxSummary page 1…Ethicon Bone Wax, (Pre-amendment) Orthostat Bone Putty, K043260 Autosuture Bone Wax, K971680 Manufacturer. CP Medical 803 NE 25th Ave. Portlan… | 1997 |
| * | — | Ethicon Bone Wax 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? (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 27 years and passes through 4 companies; a new generation was cleared every 5.7 years on median.
- 2 of the 8 ancestors have a recall of any class.
- 5 other devices also cite its predicate K024372.
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 Oscera7TM Synthetic Absorbable Bone Wax is indicated in the control of bleeding from cut or damaged bones by acting as a pressure tamponade, or mechanical barrier.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060987 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060987: OSCERA7 Synthetic Absorbable Bone Wax, Model OS31.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060987
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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