Atlas FDA

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

Next Orthosurgical — Predicate Candidate Screening

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

112 daysmedian FDA review time
275 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K242509HAnano InterFuse(R) Modular InterbodyNext Orthosurgical2024-09-19280
K190981NEX-D2 Posterior Fixation SystemNext Orthosurgical2020-01-152750
K161608InterForm Cervical Interbody Cage SystemNext Orthosurgical2016-09-301120
K161499VertiForm Posterior Fixation SystemNext Orthosurgical2016-07-29580
K141291VERTIFORM POSTERIOR FIXATION SYSTEMNext Orthosurgical2014-08-26990
K131082INTERFORM INTERBODY CAGE SYSTEMNext Orthosurgical2013-08-261300

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