Table 3: FDA-approval dates and applications approved for in bone regeneration for growth factors and bioactive molecules (*= was withdrawn from the market in 2014 [149]).
([Ref]= references for FDA Approval Date and Application Approved For)
| Device (Growth Factor/ Bioactive Molecules) | FDA Approval Date | Application Approved For | [Ref] |
|---|---|---|---|
| Infuse (BMP-2) Device | 2002 | anterior lumbar interbody fusion | [147] |
| 2004 | tibial nonunion | [143, 170] | |
| 2007 | alternative to autogenous bone graft for sinus augmentations, and for localized alveolar ridge augmentations for defects associated with extraction sockets. | [143, 170, 171] | |
| OP-1 (BMP-7) Device* | 2001 | alternative to autograft in recalcitrant long bone nonunions where use of autograft is unfeasible and alternative treatments have failed | [172] |
| 2004 | revision posterolateral lumbar fusion | [173] | |
| Augment (PDGF-BB) | 2015 | surgical fusion of ankle (tibiotalar joint) and/or hindfoot (including subtalar, talonavicular, and calcaneocuboid joints) | [174] |
| GEM 21S (PDGF-BB) | 2005 | Periodontal defects | [136] |
| iFactor (P-15) | 2015 | reconstruction of a degenerated cervical disc at one level from C3-C4 to C6- C7 following single-level discectomy for intractable radiculopathy after conservative treatment failure | [175] |