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

Apex Surgical, LLC — Predicate Candidate Screening

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

90 daysmedian FDA review time
154 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K043123APEX MODULAR HA HIP STEMApex Surgical, LLC2005-02-10900
K041950APEX K2 HIP SYSTEMApex Surgical, LLC2004-12-211540
K031110APEX MODULAR ACETABULAR CUPApex Surgical, LLC2003-05-22440
K012918APEX MODULAR ALUMINA FEMORAL HEADApex Surgical, LLC2001-11-27890
K003923APEX MODULAR ZIRCONIA FEMORAL HEADApex Surgical, LLC2001-03-20900
K000788APEX MODULAR HIP STEMApex Surgical, LLC2000-08-041470

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