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

Landos, Inc. — Predicate Candidate Screening

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

233 daysmedian FDA review time
444 days90th percentile
15clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K964226MEMORY STAPLE (20 SIZES AVAILABLE)Landos, Inc.1997-08-052860
K97106834MM SCARF THREAD-HEAD(TM) SCREWLandos, Inc.1997-07-091070
K971070SCARF THREAD-HEAD (TM) HEAD SCREWLandos, Inc.1997-07-091070
K971069TWIST-OFF (TM) SCREWLandos, Inc.1997-07-091070
K961732KARLandos, Inc.1997-07-084310
K97084622.2/+4MM CO CR & ZIRCONIA FEMORAL HEADLandos, Inc.1997-06-05900
K953111CORAILLandos, Inc.1996-12-275430
K962233TWIST-OFF SCREWLandos, Inc.1996-10-031140
K962236SCARF THREAD-HEAD SCREWLandos, Inc.1996-09-201010
K960642NANCY NAILLandos, Inc.1996-05-17930
K943727BIOSTOP G BONE CEMENT RESTRICTORLandos, Inc.1995-05-112821
K933108TITAN TROCHANTERO-DIAHYSEAL TOTAL HIP PROSTHESISLandos, Inc.1994-09-124440
K935185MORPHOMETRIC TOTAL HIP PROSTHESISLandos, Inc.1994-06-162330
K932935TITAN DYSPLASIC TOTAL HIP PROSTHESISLandos, Inc.1994-06-153640
K933567EUROFORM TOTAL HIP PROSTHESISLandos, Inc.1994-05-162980

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