510(k) · Cleared
ClearedViagraf DBM Paste
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osteotech, Inc. · MBP Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)
Cleared on Dec 5, 2005 as substantially equivalent to K020078 (Exactech, Inc., 2004) and 3 other predicates after a 381-day review. Its family tree reaches back 3 generations to 1997.
- Decided
- Dec 5, 2005
- Review
- 381 days
- Class
- Class II
- Product code
- MBP
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K963562 (1997). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK963562 Wright Plaster of Paris PelletsWrightmedicaltechnologyinc · 1997
- 2 generations backK020078 Exactech Resorbable Bone PasteExactech, Inc. · 2004
- 1 generation backK040755 Exactech Resorbable Room Temperature Bone PasteExactech, Inc. · 2004
- This deviceK043209 Viagraf DBM PasteOsteotech, Inc. · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K963562 | Wright Plaster of Paris Pellets | Wrightmedicaltechnologyinc | 1997 | — |
| −2 | K020078 | Exactech Resorbable Bone Paste | Exactech, Inc. | 2004 | — |
| −1 | K040755 | Exactech Resorbable Room Temperature Bone Paste | Exactech, Inc. | 2004 | — |
| 0 (this device) | K043209 | Viagraf DBM Paste | Osteotech, Inc. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 2 | 0 |
| 2004 | 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 MBP? 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 MBP device
- #1 K242799 PliaFX Floscore 9.0 · 3 generations · no Class I recall
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 |
|---|---|---|---|
| * | K020078 | Exactech Resorbable Bone PasteSummary page 1…redicate devices. Trade/Proprietary/Model Name Manufacturer 510(K) # Exactech Resorbable Bone Paste Exactech K020078 Exactech Resorbable Room Exactech K040755 Temperature Bone Paste AllomatrixPutty… | 2004 |
| * | K040755 | Exactech Resorbable Room Temperature Bone PasteSummary page 1…510(K) # Exactech Resorbable Bone Paste Exactech K020078 Exactech Resorbable Room Exactech K040755 Temperature Bone Paste AllomatrixPutty Wright Medical K020895 Allomatrix Putty… | 2004 |
| * | K020895 | Allomatrix Model# 86Summary page 1…ech Resorbable Room Exactech K040755 Temperature Bone Paste AllomatrixPutty Wright Medical K020895 Allomatrix Putty Wright Medical K041186 4. Device Description: VIAGRAF 0 DBM Paste is… | 2004 |
| * | K041168 | Allomatrix Putty Our reading of the summary gave K041186, FDA’s number for CADDY (Afikim Electric Vehicles). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Allomatrix Putty”. | 2004 |
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 8 years and passes through 3 companies; a new generation was cleared every 1.5 years on median.
- None of the 7 ancestors has a recall.
- 7 other devices also cite its predicate K020078.
How does its category compare?
All MBP devicesMBP Filler, Bone Void, Osteoinduction (W/O Human Growth Factor): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MBP
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · MBP
181in 2013
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MBP
7in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MBP
2in 2025
MAUDE reports naming product code MBP, 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 | 5 | 188 | 0 | 7 |
| 2008 | 5 | 93 | 0 | 15 |
| 2009 | 1 | — | 0 | 9 |
| 2010 | 0 | — | 0 | 14 |
| 2011 | 1 | — | 2 | 18 |
| 2012 | 1 | — | 13 | 24 |
| 2013 | 3 | 181 | 0 | 16 |
| 2014 | 0 | — | 1 | 15 |
| 2015 | 1 | — | 0 | 11 |
| 2016 | 0 | — | 1 | 6 |
| 2017 | 0 | — | 0 | 5 |
| 2018 | 0 | — | 0 | 9 |
| 2019 | 0 | — | 0 | 3 |
| 2020 | 0 | — | 0 | 6 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 0 | — | 7 | 6 |
| 2024 | 1 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 0 | — | 2 | — |
What is it indicated for?
VIAGRAFO DBM Paste is intended for use in filling bony voids or gaps of the extremities that are not intrinsic to the stability of the bony structure. The voids or gaps may be surgically created defects or defects created by traumatic injury to the bone. VIAGRAF 0 DBM Paste is resorbed/remodeled and is replaced by host bone during the healing process.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043209 · printed Nov 4, 2026
Cite this page
510(k) Report. “K043209: Viagraf DBM Paste.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K043209
Report an extraction error
Are you the manufacturer?
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