Atlas FDA

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

Novastep — Predicate Candidate Screening

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

115 daysmedian FDA review time
286 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K230724arcad® 2.0 Duo & Quadro osteosynthesis compressive staplesNovastep2023-12-042630
K223468Nexis® compressive screwsNovastep2023-08-302860
K192356Airlock Centrolock Osteosynthesis Implant SystemNovastep2019-12-141070
K151277Airlock® osteosynthesis plate systemNovastep2015-08-13910
K143523Airlock osteosynthesis plate systemNovastep2015-04-061150
K143049LYNC intramedullary implantNovastep2015-02-191190
K143146Nexis osteosynthesis snap-off screwsNovastep2015-02-06950
K143229Nexis osteosynthesis compressive screwsNovastep2015-02-06880

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