510(k) · Cleared
ClearedosteoSPAN Morpheus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biogennix · MQV Filler, Bone Void, Calcium Compound
Cleared on Jan 15, 2015 as substantially equivalent to K093342 (Biogennix, LLC, 2010) and 1 other predicate after a 107-day review. Its family tree reaches back 6 generations to 1996. 2 later devices descend from it.
- Decided
- Jan 15, 2015
- Review
- 107 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K960978 (1996). 11 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK960978 Wright Plaster of Paris Pellets (Subject to Revision)Wrightmedicaltechnologyinc · 1996
- 5 generations backK980817 Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model…Interpore Intl. · 1998
- 4 generations backK030131 Ossatura BCP Bone Void FillerIsotis NV · 2003
- 3 generations backK040082 Pore-SI Bone Graft SubstituteApatech, Ltd. · 2004
- 2 generations backK071206 Actifuse Abx E-Z-Fil Putty Bone Graft SubstituteApatech, Ltd. · 2007 · Recalled
- 1 generation backK132377 Osteospan MorpheusBiogennix, LLC · 2014
- This deviceK142828 osteoSPAN MorpheusBiogennix · 2015
- Descendant · cites it directly · 0 of its ownK193487 Agilon StripBiogennix, LLC · 2020
- Descendant · cites it directly · 0 of its ownK193168 Agilon MoldableBiogennix, LLC · 2020
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K960978 | Wright Plaster of Paris Pellets (Subject to Revision) | Wrightmedicaltechnologyinc | 1996 | — |
| −5 | K980817 | Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model Numbers 5RG05… | Interpore Intl. | 1998 | — |
| −4 | K030131 | Ossatura BCP Bone Void Filler | Isotis NV | 2003 | — |
| −3 | K040082 | Pore-SI Bone Graft Substitute | Apatech, Ltd. | 2004 | — |
| −2 | K071206 | Actifuse Abx E-Z-Fil Putty Bone Graft Substitute | Apatech, Ltd. | 2007 | 1 |
| −1 | K132377 | Osteospan Morpheus | Biogennix, LLC | 2014 | — |
| 0 (this device) | K142828 | osteoSPAN Morpheus | Biogennix | 2015 | — |
| +1 | K193487 | Agilon Strip | Biogennix, LLC | 2020 | — |
| +1 | K193168 | Agilon Moldable | Biogennix, LLC | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 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 MQV? 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 MQV device
- #1 K232315 Catalyst Bone Void Fillerscore 25.2 · 25 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 |
|---|---|---|---|
| * | K093342 | Biogennix RPCSummary page 5…use in posterolateral spine fusion and updated instructions for use which now include guidelines for use in posterolateral spine fusion. The osteoSPAN predicate device (K093342) is the primary component of osteoSPAN Morpheus and has not been altered in any way; therefore, both devices have identical osteo… | 2010 |
| * | K132377 | Osteospan MorpheusSummary page 5…one to one ratio with autogenous bone graft. SUMMARY of HOW TECHNOLOGICAL CHARACTERISTICS COMPARE: The subject device is IDENTICAL to osteoSPAN Morpheus cleared under K132377, except for an expanded indication for use in posterolateral spine fusion and updated instructions for use which now include guid… | 2014 |
What descends from it? (2)
2 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 19 years and passes through 6 companies; a new generation was cleared every 2.8 years on median.
- 1 of the 11 ancestors has a recall of any class.
- Of its descendants, K193487 (Biogennix, LLC, 2020) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K093342.
How does its category compare?
All MQV devicesMQV Filler, Bone Void, Calcium Compound: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · MQV
14in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MQV
57in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MQV
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MQV
57in 2025
MAUDE reports naming product code MQV, 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 | 35 | 144 | 5 | 67 |
| 2008 | 32 | 102 | 3 | 71 |
| 2009 | 23 | 180 | 1 | 81 |
| 2010 | 17 | 147 | 0 | 68 |
| 2011 | 16 | 92 | 6 | 114 |
| 2012 | 9 | 107 | 3 | 149 |
| 2013 | 12 | 197 | 2 | 223 |
| 2014 | 20 | 153 | 0 | 111 |
| 2015 | 18 | 184 | 0 | 125 |
| 2016 | 8 | 214 | 1 | 106 |
| 2017 | 17 | 124 | 1 | 107 |
| 2018 | 23 | 124 | 2 | 86 |
| 2019 | 13 | 90 | 0 | 65 |
| 2020 | 15 | 132 | 1 | 126 |
| 2021 | 8 | 88 | 0 | 101 |
| 2022 | 9 | 118 | 0 | 47 |
| 2023 | 21 | 74 | 3 | 120 |
| 2024 | 28 | 55 | 2 | 68 |
| 2025 | 14 | 57 | 1 | 57 |
| 2026 | 5 | 96 | 4 | — |
What is it indicated for?
BIOGENNIX osteoSPAN Morpheus is indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure. It is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, posterolateral spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides bone void filler that resorbs and is replaced with bone during the healing process. When used in the posterolateral spine, osteoSPAN Morpheus must be used as a bone graft extender, mixed in a one to one ratio with autogenous bone graft.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142828 · printed Nov 5, 2026
Cite this page
510(k) Report. “K142828: osteoSPAN Morpheus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K142828
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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