ClearanceBrief
Panels › Orthopedic › Product code KWL · Class 2

Prosthesis, Hip, Hemi-, Femoral, Metal

Regulation 888.3360

3510(k)s in 12 months (108 all time)
1recalls in 12 months (51 all time)
44recalls that name a 510(k)
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Top companies in KWL

Company510(k)sRecalls
Stryker Howmedica Osteonics Corp.043
Osteonics Corp.80
Depuy, Inc.70
Howmedica Osteonics Corp.34
Biomet, Inc.60
Osteoremedies, LLC60
Howmedica Corp.50
Orthomet, Inc.40
DePuy Orthopaedics, Inc.03
Intermedics Orthopedics30
Decided510(k)Device and applicantCode
Jul 24, 2026K262290REMEDY POLY+PLUS SNAP FIT Acetabular Cup
Osteoremedies, LLC
KWL
May 15, 2026K260536Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone Cement
Depuy Ireland UC, IE
KWL
Dec 23, 2025K253675OsteoRemedies Hip Spacer System
Osteoremedies, LLC
KWL
Aug 6, 2025K252326InterSpace GV Hip Spacer
Tecres S.P.A., IT
KWL
Jun 12, 2025K242865Synicem Hip Spacer; Synicem Knee Spacer; Synicem Shoulder Spacer
Biocomposites, Ltd., GB
KWL
Feb 15, 2024K234028COPAL® exchange G hip spacer; COPAL® G+V
Heraeus Medical GmbH, DE
KWL
Oct 21, 2022K222632UHR Bipolar Implants, Restoration GAP II Implants
Howmedica Osteonics Corp., Dba Stryker Orthopaedics
KWL
Jan 10, 2020K192995OsteoRemedies Hip Spacer System
Osteoremedies, LLC
KWL
Aug 23, 2019K191981REMEDY Acetabular Cup
Osteoremedies, LLC
KWL
Aug 29, 2018K172906REMEDY PLUS Hip Spacer, UNITE PLUS Bone Cement
Osteoremedies, LLC
KWL
Feb 22, 2018K173967Remedy Acetabular Cup
Osteoremedies, LLC
KWL
Mar 17, 2015K143184Evolve UniPolar Head
Signature Orthopaedics Pty, Ltd., AU
KWL
Apr 5, 2012K1124702GC HIP/KNEE MODULAR SPACER
Mandell Horwitz Consultants, LLC
KWL
Sep 20, 2011K101356Spacer-G and Spacer-K
Tecres S.P.A.
KWL
Aug 4, 2011K111911CORIN OPTIMOM MODULAR HEAD
Corin USA
KWL
May 22, 2008K062273SPACER-G TEMPORARY HIP PROSTHESIS
Tecres S.P.A.
KWL
Sep 10, 2007K071471CORIN ADAPTOR SLEEVE
Howmedica Osteonics Corp.
KWL
Apr 3, 2007K063791CORIN UNIPOLAR MODULAR HEAD
Corin USA
KWL
Sep 12, 2006K062408SMITH & NEPHEW MODULAR FEMORAL (HEMI) HEAD
Smith & Nephew, Inc.
KWL
Jul 17, 2006K061243SMITH & NEPHEW MODULAR FEMORAL HEAD
Smith & Nephew, Inc.
KWL
Jan 27, 2005K042973SOLITUDE UNIPOLAR HEAD
Ortho Development Corp.
KWL
Jan 22, 2004K031841SPACER G TEMPORARY HIP PROSTHESIS
Exactech, Inc.
KWL
May 30, 2003K030972FIXION UNIPOLAR MODULAR HEMI-HIP SYSTEM (FIXION MH)
Disc-O-Tech Medical Technologies, Ltd., IL
KWL
Apr 1, 2003K030205CONSENSUS UNIPOLAR HEAD, COCR
Hayes Medical, Inc.
KWL
Jan 25, 2002K014226UNITRAX MODULAR UNIPOLAR SYSTEM
Howmedica Osteonics Corp.
KWL
Sep 1, 1999K992570UNITRAX C-TAPER NECK ADJUSTMENT SLEEVE
Howmedica Osteonics Corp.
KWL
Mar 15, 1999K990309PLUS FRACTURE HEAD PROSTHESIS
Plus Orthopedics
KWL
Feb 24, 1999K984585OSTEONICS +10 UNIPOLAR ADAPTOR SLEEVE
Osteonics Corp.
KWL
Jan 19, 1999K984028THE NEW BIO-MOORE ENDO HEADS
Biomet, Inc.
KWL
Aug 21, 1998K981451ARGOMEDICAL BIPOLAR SYSTEM
Stelkast Company
KWL
Mar 16, 1998K974807OSTEO AUSTIN MOORE ENDOPROSTHESIS SYSTEM
Osteonics Corp.
KWL
Dec 18, 1997K973614FOUNDATION UNIPOLAR FEMORAL HEAD WITH MODULAR NECK LENGTH SLEEVES
Encore Orthopedics, Inc.
KWL
Jul 23, 1997K965198ULTIMA TPS CEMENTED STEM
Johnson & Johnson International
KWL
Jan 24, 1997K965156ULTIMA*UNIPOLAR HEAD AND ADAPTER SLEEVES
Johnson & Johnson Professionals, Inc.
KWL
Sep 23, 1996K962646PRIME MODULAR ENDO HEAD
Orthopaedic Innovations, Inc.
KWL
Mar 27, 1996K960538OPTEON UNIPOLAR
Exactech, Inc.
KWL
Jan 30, 1996K955385JOHNSON & JOHNSON AUSTIN MOORE STEM
Johnson & Johnson Professionals, Inc.
KWL
Nov 30, 1995K954534OSTEONICS UNIPOLAR ENDO HEAD
Osteonics Corp.
KWL
Nov 15, 1995K954077UNITRAX V40 MODULAR ADAPTOR
Howmedica Corp.
KWL
Aug 14, 1995K943778OSTEONICS RESTORATION CEMENTED HIP STEM SERIES
Osteonics Corp.
KWL
Jun 7, 1995K950563ULTIMA AUGMENTED UHMWPE CUP
Johnson & Johnson Professionals, Inc.
KWL
May 25, 1995K951355LINK SADDLE PROTHESIS
Turnkey Intergration USA, Inc.
KWL
Oct 7, 1994K931753CORIN THOMPSON PROSTHESIS, MODIFICATION
Corin Orthopedic Products
KWL
Oct 7, 1994K931752CORIN AUSTIN-MOORE PROSTHESIS, MODIFICATION
Corin Orthopedic Products
KWL
Sep 29, 1994K940190ULTIMA UNIPOLAR MODULAR HEAD
Johnson & Johnson Orthopaedics, Inc.
KWL
Apr 25, 1994K934353ZIRCONIUM ALLOY UNI-POLAR HEAD
Smith & Nephew Richards, Inc.
KWL
Aug 25, 1993K924050TITANIUM NITRIDE COATED HEMI-HEAD COMPONENT
Orthomet, Inc.
KWL
Mar 31, 1993K926120CONTOUR FEMORAL HIP STEM WITH POROCOAT
Depuy, Inc.
KWL
Feb 12, 1993K924379ULTIMA(TM) TOTAL HIP SYSTEM CEMENTED FEMORAL STEM
Johnson & Johnson Orthopaedics, Inc.
KWL
Aug 11, 1992K922146OSTRONCS HEMI-HIP STEM SERIES
Osteonics Corp.
KWL

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