Atlas FDA

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

Cintor Orthopaedic Div. — Predicate Candidate Screening

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

34 daysmedian FDA review time
65 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K811451RADIAL HEAD PROSTHESISCintor Orthopaedic Div.1981-06-09180
K810540KNEE PROSTHESISCintor Orthopaedic Div.1981-04-07390
K810353HARRIS CEMENT RESTRICTORCintor Orthopaedic Div.1981-02-23130
K803106AGINSKY NAILCintor Orthopaedic Div.1981-02-12650
K803074FERNORAL HIP PROSTHESISCintor Orthopaedic Div.1981-01-08340
K802627ORTRON 90* HIP PROSTHESISCintor Orthopaedic Div.1980-12-16540
K802814ORTHOFIX AXIALEXTERNAL FIXATION SYS.Cintor Orthopaedic Div.1980-12-10330

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