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

Endotec, Inc. — Predicate Candidate Screening

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

187 daysmedian FDA review time
290 days90th percentile
15clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K081400FANNING-PAPPAS MODULAR KNEE BEARINGEndotec, Inc.2009-02-202770
K012702BUECHEL-PAPPAS (B-P) FIXED BEARING NEW JERSEY (NJ) TOTAL KNEEndotec, Inc.2002-01-301691
K992394BUECHEL-PAPPAS HUMERAL HEAD RESURFACING COMPONENTEndotec, Inc.1999-10-15880
K982418BUECHEL-PAPPAS MODULAR SALVAGE STEMEndotec, Inc.1999-04-292900
K963101B-P HEMISPHERICAL ACETABULAR COMPONENTEndotec, Inc.1997-02-121871
K963100TRONZO ACETABULAR FIXATION COMPONENT (1 99-02-00XX (ACE. FIXEndotec, Inc.1997-02-121870
K960425BUECHEL-PAPPAS POLYETHLENE ACETABULAR COMPONENT(01-42-YYXX &Endotec, Inc.1996-10-032483
K960424BUECHEL-PAPPAS POLYETHYLENE GLENOID COMPONENT (02-11-YYXX) NEndotec, Inc.1996-08-262100
K945254ELECTROSURGICAL CUTTING & COAGULATION DEVICE ACCESSORIESEndotec, Inc.1995-06-062210
K944465CARRIER, LIGATURE (79 GEJ)Endotec, Inc.1994-09-28160
K944414DEKALBEndotec, Inc.1994-09-27190
K905262BUECHEL-PAPPAS EXTENDED COLLAR FEMORAL STEM PROSTHEndotec, Inc.1993-05-199080
K904870MODIFIED NEW JERSEY FEMORAL HIP RESURFACING COMPONEndotec, Inc.1991-05-232123
K904879BEUCHEL-PAPPAS GLENOID COMPONENTEndotec, Inc.1991-01-28900
K904880BUECHEL-PAPPAS HUMERAL STEM COMPONENTEndotec, Inc.1991-01-28901

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