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

Kinamed, Inc. — Predicate Candidate Screening

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

89 daysmedian FDA review time
270 days90th percentile
33clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K122049NEUROPRO LOW PROFILE CRANIAL PLATING SYSTEMKinamed, Inc.2013-04-052670
K072250SUPERCABLE GRIP AND PLATE SYSTEMKinamed, Inc.2007-11-09881
K050897NAVIPRO SHOULDER SOFTWARE MODULEKinamed, Inc.2005-05-24460
K033668NAVIPRO KNEE SOFTWARE MODULEKinamed, Inc.2004-03-111110
K032950GEM INSET PATELLAR COMPONENTKinamed, Inc.2003-12-19880
K030256ISO-ELASTIC CERCLAGE SYSTEMKinamed, Inc.2003-10-212700
K020764NAVIPROKinamed, Inc.2002-06-03880
K013982KINEMATCH PATELLO-FEMORAL RESURFACING IMPALANTKinamed, Inc.2002-05-211690
K010101GEM POSTERIOR STABILIZED TOTAL KNEE SYSTEMKinamed, Inc.2001-05-171260
K003347ORTHOPILOTKinamed, Inc.2001-02-231210
K994214GEM KNEE SYSTEMKinamed, Inc.2000-07-192180
K982927QUICK TAP SELF DRILLING SCREWKinamed, Inc.1998-09-08190
K964362KINAMED PROFIX SYSTEMKinamed, Inc.1997-01-16760
K954219REALITY LONG STEM HIP SYSTEMKinamed, Inc.1995-12-04870
K954213ATH FULL PROFILE ACETABULAR CUP SYSTEMKinamed, Inc.1995-10-25480
K922247KINAMED REALITY TOTAL HIP SYSTEMKinamed, Inc.1994-03-306860
K920290KINAMED 32MM BIOCERAM-Z TOATAL HIP FEMORAL BALLKinamed, Inc.1992-11-032860
K920219KINAMED 26MM BIOCERAN-Z TOTAL HIP FEMORAL BALLKinamed, Inc.1992-10-302880
K922421KINAMED ATH-POROUS AND ATH-POROUS LONG TOTAL HIPKinamed, Inc.1992-10-151470
K915309KINAMED 22MM BIOCERAM-Z TOTAL HIP FEMORAL BALLKinamed, Inc.1992-02-19890
K915310KINAMED 28MM BIOCERAM-Z TOTAL HIP FEMORAL BALLKinamed, Inc.1992-02-19890
K914843KINAMED ATH-HA & ATH-HA LONG TOTAL HIPKinamed, Inc.1992-02-03980
K914237KINAMED CTN STEMKinamed, Inc.1991-12-05760
K912295KINAMED ATH 28MM ALUMINA CERAMIC LONG-NECK BALLKinamed, Inc.1991-08-12820
K903976CTH STABILO TOTAL HIP REPLACEMENT SYSTEMKinamed, Inc.1991-01-091340
K903884KINAMED ATH 26MM COCR TOTAL HIP FEMORAL HEADKinamed, Inc.1990-09-13230
K903885KINAMED ATH 22MM COCR TOTAL HLIP FEMORAL HEADKinamed, Inc.1990-09-13230
K902073KINAMED CEMENTED ATH-LONG STEMKinamed, Inc.1990-06-08320
K902074KINAMED CEMENTED CTH STEMKinamed, Inc.1990-06-08320
K894904KINAMED CERAMIC ATH TOTAL HIP - 28MM BALLKinamed, Inc.1990-03-192300
K893821ACETABULAR SHELLS & LINERS FOR ATH TOTAL HIP SYST.Kinamed, Inc.1989-11-061670
K890472ATH CERAMIC UHMWPE TOTAL HIP SYSTEMKinamed, Inc.1989-09-012140
K882675ATH METAL:UHMWPE TOTAL HIP SYSTEMKinamed, Inc.1988-08-19520

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