510(k) · Cleared
ClearedBiogennix RPC
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biogennix, LLC · MQV Filler, Bone Void, Calcium Compound
Cleared on Jul 29, 2010 as substantially equivalent to K990131 (Interpore Cross Intl., 1999) after a 276-day review. Its family tree reaches back 1 generation to 1999. 5 later devices descend from it.
- Decided
- Jul 29, 2010
- Review
- 276 days
- Class
- Class II
- Product code
- MQV
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K990131 (1999). 5 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK990131 Pro Osteon Implant 500R Resorbable Bone Graft SubstituteInterpore Cross Intl. · 1999
- This deviceK093342 Biogennix RPCBiogennix, LLC · 2010
- Descendant · cites it directly · 4 of its ownK132377 Osteospan MorpheusBiogennix, LLC · 2014
- Descendant · cites it directly · 2 of its ownK142828 osteoSPAN MorpheusBiogennix · 2015
- Descendant · 2 generations on · 0 of its ownK193487 Agilon StripBiogennix, LLC · 2020
- Descendant · 2 generations on · 0 of its ownK193168 Agilon MoldableBiogennix, LLC · 2020
- Descendant · 2 generations on · 0 of its ownK190371 Morpheus-CBiogennix, LLC · 2019
Most influential descendants
Showing 5 of 5 · See all- K132377Osteospan MorpheusBiogennix, LLC · 2014 · cites it directly4descendants
- K142828osteoSPAN MorpheusBiogennix · 2015 · cites it directly2descendants
- K193487Agilon StripBiogennix, LLC · 2020 · 2 generations on0descendants
- K193168Agilon MoldableBiogennix, LLC · 2020 · 2 generations on0descendants
- K190371Morpheus-CBiogennix, LLC · 2019 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K990131 | Pro Osteon Implant 500R Resorbable Bone Graft Substitute | Interpore Cross Intl. | 1999 | — |
| 0 (this device) | K093342 | Biogennix RPC | Biogennix, LLC | 2010 | — |
| +1 | K132377 | Osteospan Morpheus | Biogennix, LLC | 2014 | — |
| +1 | K142828 | osteoSPAN Morpheus | Biogennix | 2015 | — |
| +2 | K193487 | Agilon Strip | Biogennix, LLC | 2020 | — |
| +2 | K193168 | Agilon Moldable | Biogennix, LLC | 2020 | — |
| +2 | K190371 | Morpheus-C | Biogennix, LLC | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2019 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K990131 | Pro Osteon Implant 500R Resorbable Bone Graft SubstituteSummary page 1…MQV Panel Orthopedic Regulation Number: 21 CFR 888.3045 4. Predicate Pro Osteon 5OOR (K990131), marketed by Interpore Cross Device 5. Device Biogennix RPC is an osteoconductive, open cell, resorbable ceramic. The… | 1999 |
What descends from it? (5)
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?
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. 2010, 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 RPC is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. Biogennix RPC is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the home. Biogennix PRC may be used as a bone graft extender in posterolateral spine fusion when mixed in a one to one ratio with autogenous bone graft. The product provides bone void filler that resorbs and is replaced with bone during the healing process.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093342 · printed Nov 5, 2026
Cite this page
510(k) Report. “K093342: Biogennix RPC.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K093342
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