Atlas FDA

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

Implantology Corp. · Predicate Candidate Screening

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

518 daysmedian FDA review time
581 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K934729UFC HIP STEM COMPONENTS: HYDROXYLAPATITE COATEDImplantology Corp.1994-07-222960
K915529FPC/SFPC/RFPC ACETABULAR COMPONENTImplantology Corp.1993-07-135810
K915528BHR BIPOLAR FEMORAL HEAD COMPONENTImplantology Corp.1993-06-295670
K915527CPS ACETABULAR COMPONENTImplantology Corp.1993-06-245620
K915385PPC HIP STEM COMPONENTImplantology Corp.1993-05-175350
K915391FPC HIP STEM COMPONENTImplantology Corp.1993-04-305180
K924099UFC HIP STEM COMPONENTImplantology Corp.1993-04-302600
K915798PSK POSTERIOR STABILIZED TOATAL KNEEImplantology Corp.1993-03-044360
K915584CRK CONDYLAR RESURFACING TOTAL KNEEImplantology Corp.1993-02-124270

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