510(k) · Cleared
ClearedOrthoblast II Putty and Paste
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Isotis Orthobiologics, Inc. · MBP Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)
Cleared on Dec 5, 2005 as substantially equivalent to K040419 (Isotis Orthobiologics, Inc., 2005) after a 269-day review. Its family tree reaches back 2 generations to 2004. 8 later devices descend from it.
- Decided
- Dec 5, 2005
- Review
- 269 days
- Class
- Class II
- Product code
- MBP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K040980 (2004). 3 ancestors in all. 8 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK040980 Allomatrix C Putty, Allomatrix Custom Putty, Allomatrix DR Putty…Wrightmedicaltechnologyinc · 2004
- 1 generation backK040419 Dynagraft IIIsotis Orthobiologics, Inc. · 2005
- This deviceK050642 Orthoblast II Putty and PasteIsotis Orthobiologics, Inc. · 2005
- Descendant · cites it directly · 2 of its ownK091193 Accell EVO3CIsotis Orthobiologics, Inc. · 2009 · Recalled
- Descendant · cites it directly · 2 of its ownK061668 Optecure +CCCExactech, Inc. · 2006
- Descendant · 2 generations on · 1 of its ownK212135 Dry DBM- A PuttySeaspine Corporation · 2021
- Descendant · 2 generations on · 1 of its ownK121989 Optecure Bone Void Filler (0.5 CC, 1CC, 2CC, 5CC, 10CC, and 20CC)…Exactech, Inc. · 2012
- Descendant · cites it directly · 1 of its ownK070751 Orthoblast II DBM Demineralized Bone Matrix Paste and PuttyIsotis Orthobiologics, Inc. · 2007
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K091193Accell EVO3CIsotis Orthobiologics, Inc. · 2009 · cites it directly2descendants
- K061668Optecure +CCCExactech, Inc. · 2006 · cites it directly2descendants
- K212135Dry DBM- A PuttySeaspine Corporation · 2021 · 2 generations on1descendant
- K121989Optecure Bone Void Filler (0.5 CC, 1CC, 2CC, 5CC, 10CC, and 20CC), Optecure + CCC Bone…Exactech, Inc. · 2012 · 2 generations on1descendant
- K070751Orthoblast II DBM Demineralized Bone Matrix Paste and PuttyIsotis Orthobiologics, Inc. · 2007 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K040980 | Allomatrix C Putty, Allomatrix Custom Putty, Allomatrix DR Putty, Ignite… | Wrightmedicaltechnologyinc | 2004 | — |
| −1 | K040419 | Dynagraft II | Isotis Orthobiologics, Inc. | 2005 | — |
| 0 (this device) | K050642 | Orthoblast II Putty and Paste | Isotis Orthobiologics, Inc. | 2005 | — |
| +1 | K091193 | Accell EVO3C | Isotis Orthobiologics, Inc. | 2009 | 1 |
| +1 | K061668 | Optecure +CCC | Exactech, Inc. | 2006 | — |
| +2 | K212135 | Dry DBM- A Putty | Seaspine Corporation | 2021 | — |
| +2 | K121989 | Optecure Bone Void Filler (0.5 CC, 1CC, 2CC, 5CC, 10CC, and 20CC), Optecure +… | Exactech, Inc. | 2012 | — |
| +1 | K070751 | Orthoblast II DBM Demineralized Bone Matrix Paste and Putty | Isotis Orthobiologics, Inc. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 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 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? (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 |
|---|---|---|---|
| * | K040419 | Dynagraft II Our reading of the summary gave K040416, FDA’s number for Sonicare Advance Toothbrush, Model 4900 (Philips Oral Healthcare, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “DynaGraft II Putty and Gel”. | 2005 |
What descends from it? (8)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 1 year and passes through 2 companies; a new generation was cleared every 8 months on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K091193 (Isotis Orthobiologics, Inc., 2009) has gone furthest, with 2 descendants of its own.
- 7 other devices also cite its predicate K040419.
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?
OrthoBlast® II is an osteoinductive and osteoconductive bone filling material indicated:
OrthoBlast® I is indicated for orthopedic applications as filler for gaps or voids that are not intrinsic to the stability of the bony structure. OrthoBlast® II is indicated to be packed gently into bony gaps in the skeletal system as a bone graft extender and as a bone void filler of the extremities and pelvis. These defects may be surgically created or from the result of traumatic injury to the bone.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050642 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050642: Orthoblast II Putty and Paste.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050642
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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