EBI

Summary

Five original PMAs map to the six displayed families: P790002 (EBI Bone Healing System), P790005 (OsteoGen), P850022 (OrthoPak/SpinalPak), P850035 (SpF) and P230025 (Xstim). SpinalPak’s lumbar-fusion indication is documented in P850022S009. Supplements are not counted as separate original approvals. ^{[19][20][21][22][23][24]}

The reviewed product-code dataset contains 181 records across these five PMA families, including supplements. This profile stores the five originals and the specifically relevant SpinalPak indication supplement. It is a family snapshot, not a complete model-by-model supplement chronology. Current instructions may differ from original approval-era labeling. ^{[19][20][21][22][23][24]}

Three recall events spanning 2017–2024 are represented by seven recall numbers. The Class II 2024 OrthoPak/SpinalPak and replacement lead-wire correction, event 94291, remains Open, Classified in the checked FDA records. FDA describes possible lead-wire sheath damage and loss of treatment signal. Affected products, lots and distribution dates are specific to the recall records. ^{[26][27][28][29]}

Two earlier Class I events are documented as terminated: the 2017 SpF implant cytotoxicity event 77089, terminated October 17, 2018; and the 2018 OsteoGen cleanliness-validation event 81127, terminated August 25, 2020. These events do not establish that all current devices are affected. Recall hazard classes are distinct from device risk classes. ^[25][30][31]

Named and product-code FDA searches found no relevant 510(k) clearances or De Novo grants for the current bone-stimulation families. Legacy spine, trauma, scoliosis and unrelated company/name matches are excluded. ^{[34][35][36][37]}