# K093342: Biogennix RPC

- Pathway: 510(k) (Traditional)
- Applicant: Biogennix, LLC
- Decided: Jul 29, 2010 after 276 days
- Product code: MQV (Filler, Bone Void, Calcium Compound)
- Device class: 2
- Regulation: 21 CFR 888.3045
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K990131 (1999). 1 ancestor in all.
5 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990131: Pro Osteon Implant 500R Resorbable Bone Graft Substitute, Interpore Cross Intl. (1999) Summary page 1.

## Most influential descendants
- K132377: Osteospan Morpheus (2014), 4 descendants of its own
- K142828: osteoSPAN Morpheus (2015), 2 descendants of its own
- K193487: Agilon Strip (2020), 0 descendants of its own
- K193168: Agilon Moldable (2020), 0 descendants of its own
- K190371: Morpheus-C (2019), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K093342
Methodology: https://510kreport.com/methodology