Atlas FDA

KXA

23 FDA 510(k) clearances · Product code

79 daysmedian time to decision
212 days90th percentile
23clearances measured

FDA profile

Official device name
Prosthesis, Hip, Femoral, Resurfacing
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3400
Medical specialty
Orthopedic
Flags
Implant
Adverse events (MAUDE)
2018: 430 · 2019: 971 · 2020: 373 · 2021: 17 · 2022: 13 · 2026: 12
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Biocore9 Femoral Head Resurfacing Component (K201219)Biocore9, LLC2021-01-19
CORMET CEMENTLESS RESURFACING FEMORAL HEAD (K092198)Corin USA2010-04-15
CONSERVE PRESSFIT FEMORAL COMPONENT (K082673)Wrightmedicaltechnologyinc2008-12-12
RECAP HA PRESS-FIT FEMORAL RESURFACING HEAD (K071053)Biomet, Inc.2007-06-29
DUROM HIP RESURFACING SYSTEM, FEMORAL COMPONENTS (K070292)Zimmer GmbH2007-04-26
CONSERVE FEMORAL RESURFACING COMPONENT (K062960)Wrightmedicaltechnologyinc2006-12-01
BIOPRO TARA FEMORAL RESURFACING COMPONENT (K043542)Biopro, Inc.2005-05-18
DEPUY ASR RESURFACING FEMORAL HEADS (K032659)DePuy Orthopaedics, Inc.2003-12-04
PRESS-FIT HEAD RESURFACING DEVICE (K023188)Biomet Orthopedics, Inc.2002-12-11
CONTOURED ARTICULAR PROSTHESIS (CAP) FEMORAL HEAD RESURFACING SYSTEM (K021549)Std Mfg., Inc.2002-08-01
CEMENTED FEMORAL HEAD RESURFING DEVICE (K021799)Biomet Orthopedics, Inc.2002-06-26
CORMET 2000 HEMI HIP METALLIC RESURFACING PROSTHESIS (K994153)Corin USA2000-02-25
NELSON RESURFACING HEAD (K983452)Biomet, Inc.1998-12-03
MODUILAR UNIPOLAR (K950998)Intermedics Orthopedics1995-04-13
ORTHOMET RESURFACING FEMORAL COMPONENT (K944752)Orthomet, Inc.1994-12-28
MODIFIED NEW JERSEY FEMORAL HIP RESURFACING COMPON (K904870)Endotec, Inc.1991-05-23
BIOPRO PROXIMAL FEMORAL ARTICULAR REPLACEMENT (K894604)Biopro, Inc.1989-11-17
BIPOLAR HIP SYSTEM (K892398)Orthomet, Inc.1989-05-23
LSF (R) TOTAL HIP SYSTEM - BIPOLAR COMPONENT (K883212)Implant Technology, Inc.1988-11-22
NEW JERSEY FEMORAL RESURFACING COMPONENT (K842233)Endomedics, Inc.1984-07-20
TILLMAN HIP RESURFACING REPLACEMT PROS. (K792200)Waldemar Link GmbH & Co. KG1979-12-05
TILLMAN HIPSURFACE REPLACEMENT (K781490)Waldemar Link GmbH & Co. KG1978-09-20
RESURFACE PROSTHESES FOR HIP JOINT (K761324)Holco Instrument Corp.1977-01-05

Track KXA automatically

Every clearance here is in the API, with alerts when new ones post.