Atlas FDA

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

Fx Solutions — Predicate Candidate Screening

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

234 daysmedian FDA review time
261 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K163669Humeris ShoulderFx Solutions2017-05-171410
K162455Humelock Reversed ShoulderFx Solutions2017-01-171370
K150488Humelock II Reversible Shoulder SystemFx Solutions2015-11-132610
K143721PRCT2Fx Solutions2015-08-272410
K140071HUMELOCK II CEMENTED SHOULDER SYSTEMFx Solutions2014-07-281960
K130759HUMELOCK II CEMENTLESS SHOULDER SYSTEMFx Solutions2013-11-092340
K123814HUMELOCK II CEMENTED SHOULDER SYSTEMFx Solutions2013-08-132440
K111097HUMELOCK CEMENTED SHOULDER PROSTHESISFx Solutions2011-11-092030

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