Atlas FDA

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

Bioventus, LLC — Predicate Candidate Screening

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

218 daysmedian FDA review time
267 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K243782StimTrial Neuromodulation SystemBioventus, LLC2025-07-162190
K243678TalisMann Neuromodulation SystemBioventus, LLC2025-07-032180
K233368Allograft Delivery Device (OFAC-C)Bioventus, LLC2024-06-252670
K233490SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE PuttyBioventus, LLC2023-12-05390
K162860MCS Bone GraftBioventus, LLC2017-02-131240

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