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Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Bonebridge AG — Predicate Candidate Screening

10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

88 daysmedian FDA review time
369 days90th percentile
10clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K261351SALGINA 2.5mm Distal Radius SystemBonebridge AG2026-06-26630
K260228POYA 3.5mm Medial Proximal Tibia SystemBonebridge AG2026-04-24880
K252191BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus Bonebridge AG2025-12-171560
K250933LORRAINE 2.5/3.5mm Distal Humerus SystemBonebridge AG2025-06-11750
K243308Bonebridge Osteosynthesis Plating System (SALGINA 2.5mm DistBonebridge AG2024-12-20600
K242399Bonebridge Osteosynthesis Plating SystemBonebridge AG2024-10-31790
K240318SITTER 3.5mm Versatile SystemBonebridge AG2024-08-232030
K231292TAMINA 3.5mm Proximal Humerus System; POYA 3.5MM Lateral ProBonebridge AG2023-07-19760
K213864Bonebridge Osteosynthesis Plating SystemBonebridge AG2022-09-022660
K203002SALGINA 2.5mm Volar Distal Radius System, CASCELLA 3.5mm SupBonebridge AG2021-10-053690

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda