Synergy Biomedical · Class II · Cleared Dec 20, 2024
| K-number | K241167 |
| Device name | BioSphere Putty; BioSphere MIS Putty |
| Applicant | Synergy Biomedical |
| Product code | MQV |
| Device class | Class II |
| Decision date | Dec 20, 2024 |
| Decision | Substantially Equivalent |
| Regulation | 888.3045 |
BioSphere MIS Putty is a bone void filler composed of medical-grade 45S5 bioactive glass particles. It is indicated for filling bony voids or gaps in the skeletal system (extremities and pelvis), posterolateral spine, and intervertebral disc space as a bone graft extender, where it resorbs and is replaced with bone during healing.
The device uses 45S5 bioactive glass particles in a putty form delivered via a minimally invasive surgery (MIS) applicator. The primary predicate (K203714) uses ceramic granules with polymeric binder, while the secondary predicate (K222276) uses 45S5 bioactive glass in polymeric carrier with an open-bore syringe. BioSphere MIS differs mainly in applicator design (MIS versus open-bore syringe) but shares material composition with K222276.
Not stated in this summary.
The device has identical material composition (45S5 bioactive glass) and indications to the predicate devices, including the same use in intervertebral disc space. Although the applicator differs (MIS versus open-bore syringe), this technological difference does not raise new safety or effectiveness questions because the material performance was previously validated through animal studies in posterolateral spine fusion. The device leverages prior clearance data (K173301) for sterility, shelf-life, endotoxin, pyrogenicity, and biocompatibility testing per FDA Class II Special Controls guidance.
View the full FDA submission: accessdata.fda.gov