Atlas FDA

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

Scandius Biomedical, Inc. · Predicate Candidate Screening

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

71 daysmedian FDA review time
91 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K063497MODIFICATION TO SCANDIUS TRITIS ABSORBABLE TIBIAL RECONSTRUCScandius Biomedical, Inc.2006-12-19290
K063499MODIFICATION TO SCANDIUS TRITIS TIBIAL ACL RECONSTRUCTION SYScandius Biomedical, Inc.2006-12-19290
K060522SCANDIUS TRITIS ABSORBABLE TIBIAL RECONSTRUCTION SYSTEMScandius Biomedical, Inc.2006-04-11430
K052810SCANDIUS TRITIS TIBIAL ACL RECONSTRUCTION SYSTEMScandius Biomedical, Inc.2005-12-20770
K041961SCANDIUS ABSORBABLE ACL RECONSTRUCTION SYSTEMScandius Biomedical, Inc.2004-10-20910
K041749SCANDIUS ACL RECONSTRUCTION SYSTEMScandius Biomedical, Inc.2004-09-08710

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