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

Hayes Medical, Inc. — Predicate Candidate Screening

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

88 daysmedian FDA review time
128 days90th percentile
12clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K07006136MM COCR FEMORAL HEAD AND 36MM ACETABULAR INSERTHayes Medical, Inc.2007-01-31260
K062383UNISYN HA PLASMA MODULAR HIPHayes Medical, Inc.2006-12-211280
K060635CONSENSUS ACETABULAR SHELL SYSTEMHayes Medical, Inc.2006-04-28490
K030151CONSENSUS HIP SYSTEM, UNISYN HIP SYSTEMHayes Medical, Inc.2003-04-10850
K030205CONSENSUS UNIPOLAR HEAD, COCRHayes Medical, Inc.2003-04-01700
K021466CONSENSUS ACETABULAR INSERT, CROSS-LINKED POLYETHYLENEHayes Medical, Inc.2002-07-24780
K020153CONSENSUS ACETABLAR SHELL, TI COATEDHayes Medical, Inc.2002-04-15890
K003649TRITON HIP SYSTEMHayes Medical, Inc.2001-02-23880
K001456CONSENSUS KNEE SYSTEMHayes Medical, Inc.2000-08-07900
K983004CONSENSUS FEMORAL COMPONENT, POROUS, COCR/TIHayes Medical, Inc.1998-11-25890
K964395PATIENT SPECIFIC IMPLANT (PSI) HIP FEMORAL COMPONENTHayes Medical, Inc.1997-01-27840
K953198CORTICELLOUS BONE SCREWHayes Medical, Inc.1995-11-241410

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