ClearanceBrief
Panels › Orthopedic › Product code LPH · Class 2

Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Regulation 888.3358

11510(k)s in 12 months (565 all time)
3recalls in 12 months (299 all time)
269recalls that name a 510(k)
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Top companies in LPH

DateFirm and productCodeLinked 510(k)
Dec 20, 2012DePuy Orthopaedics, Inc.
SOL SYS 8IN CALC 1.5/19.5 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added prot
Terminated
LPHK060581
Dec 20, 2012DePuy Orthopaedics, Inc.
SOL SYS 8IN CALC 1.5/18.0 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added prot
Terminated
LPHK060581
Dec 20, 2012DePuy Orthopaedics, Inc.
SOL SYS 8IN CALC 1.5/16.5 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added prot
Terminated
LPHK060581
Dec 20, 2012DePuy Orthopaedics, Inc.
SOL SYS 8IN CALC 1.5/15.0 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added prot
Terminated
LPHK060581
Dec 20, 2012DePuy Orthopaedics, Inc.
SOL SYS F 8 CALC 13.5MM LG Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added pro
Terminated
LPHK060581
Dec 20, 2012DePuy Orthopaedics, Inc.
SOL SYS 8IN CALCAR SZ12 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added protec
Terminated
LPHK060581
Dec 19, 2012DePuy Orthopaedics, Inc.
Pinnacle Cancellous Screw Packaging: Product is housed within a polyurethane protector; this is placed inside an uncoated Tyvek/PET peel pouch and sealed. This package is placed into a paperboard car
Terminated
LPHK000306
Nov 21, 2012Zimmer, Inc.
The Trilogy Acetabular System Shell with Cluster Holes Porous 56 mm O.D. Sterile The Trilogy Acetabular System is indicated for either cemented or uncemented use In skeletally mature Individuals
Terminated
LPHNone listed
Oct 31, 2012Wright Medical Technology Inc
Extremity Components: PROTHESE A EXPANSION COMPLETE D=6 LG 12 MM, Part Number PPO90000, Lot Numbers: U11113596, W12372884, W12376849, X01383482, X06391313, X07401148, X07401445, and X09418985 PROTHES
Terminated
LPHK003016
K021346 +4
Oct 31, 2012Wright Medical Technology Inc
Knee Components: ROTULE "913" D=32 , Part Number PGA00030, Lot Number X02383380 INSERT TIBIAL "913 PCR" T.1 - EP.10-, PGA00050, Lot Numbers: V11272719, W02300988, W09372781, W09372781, and W10372876
Terminated
LPHK003016
K021346 +4
Oct 31, 2012Wright Medical Technology Inc
Hip Components: INSERT MOBILE "COLLEGIA" TAILLE 58*28, OT22C58, Lot Numbers: W07335080 and X06391225 INSERT MOBILE "COLLEGIA" TAILLE 60*28, OT22C60, Lot Number: X06391226 TETE INOX "COLLEGIA" T 28/0
Terminated
LPHK003016
K021346 +4
Aug 17, 2012DePuy Orthopaedics, Inc.
Altrx" Altralinked" Polyethylene liners Description: An acetabular liner is one of the implants used during total hip arthroplasty to replace the damaged hip joint to help increase patient mobility a
Terminated
LPHK102423
Dec 1, 2011Zimmer Inc.
ZMR Over the Junction Instruments for Revision, utilized for the following ZMR devices: Porous Stem,Nitrited Porous Revision, Slotted Porous Bowed Stems with and without Compression Nut, Splined Strai
Terminated
LPHK031572
K994286
Dec 1, 2011Zimmer Inc.
ZMR Crossover Instrumentation, utilized for the following ZMR devices: Porous Stem,Nitrited Porous Revision, Slotted Porous Bowed Stems with and without Compression Nut, Splined Straight Stem, Taper S
Terminated
LPHK031572
K994286
Dec 1, 2011Zimmer Inc.
ZMR Porous Revision Hip Prosthesis Surgical Technique, utilized for the following ZMR devices: Porous Stem,Nitrited Porous Revision, Slotted Porous Bowed Stems with and without Compression Nut, Spline
Terminated
LPHK031572
K994286
Dec 1, 2011Zimmer Inc.
Zimmer ZMR Hip System Instructions for Use, utilized for the following ZMR devices: Porous Stem,Nitrited Porous Revision, Slotted Porous Bowed Stems with and without Compression Nut, Splined Straight
Terminated
LPHK031572
K994286
Nov 16, 2011Zimmer Inc.
Zimmer ZMR Femoral Spout & Cone Bodies and Trabecular Metal Hip Prosthesis Femoral Stems: FEMORAL BODY REVISION NITRIDED POROUS 12/14 NECK TAPER STANDARD 40 MM NECK OFFSET CONE BODY SIZE C 35 MM B
Terminated
LPHK994286
Nov 16, 2011Zimmer Inc.
Zimmer ZMR Femoral Spout & Cone Bodies and Trabecular Metal Hip Prosthesis Femoral Stems: FEMORAL BODY REVISION NITRIDED POROUS 12/14 NECK TAPER EXTENDED 46 MM NECK OFFSET SPOUT BODY SIZE E 55 MM BU
Terminated
LPHK994286
Nov 16, 2011Zimmer Inc.
Zimmer ZMR Femoral Spout & Cone Bodies and Trabecular Metal Primary Hip Prosthesis Femoral Stem SIZE 16 171 MM STEM LENGTH 12/14 NECK TAPER - STANDARD BODY - STANDARD NECK OFFSET TIVANIUM TI-6AL-4V
Terminated
LPHK051491
Jun 8, 2011Biomet, Inc.
Regenerex (TM) Ringloc +, Multi Hole Acetablular Cup, 64 mm Size 25, with Lock Ring, sterile, REF PT-106064, Biomet Orthopedics, Warsaw, IN. Intended Use: The Regenerex Ringloc is intended to replace
Terminated
LPHK070369
Jun 8, 2011Biomet, Inc.
Regenerex (TM) Ringloc +, Multi Hole Acetablular Cup, 62 mm Size 25, with Lock Ring, sterile, REF PT-106062, Biomet Orthopedics, Warsaw, IN. Intended Use: The Regenerex Ringloc is intended to replace
Terminated
LPHK070369
Jun 8, 2011Biomet, Inc.
Regenerex (TM) Ringloc +, Multi Hole Acetablular Cup, 60 mm Size 25, with Lock Ring, sterile, REF PT-106060, Biomet Orthopedics, Warsaw, IN. Intended Use: The Regenerex Ringloc is intended to replace
Terminated
LPHK070369
Jun 8, 2011Biomet, Inc.
Regenerex (TM) Ringloc +, Multi Hole Acetablular Cup, 56 mm Size 24, with Lock Ring, sterile, REF PT-106056, Biomet Orthopedics, Warsaw, IN. Intended Use: The Regenerex Ringloc is intended to replace
Terminated
LPHK070369
Jun 8, 2011Biomet, Inc.
Regenerex (TM) Ringloc +, Multi Hole Acetablular Cup, 54 mm Size 23, with Lock Ring, sterile, REF PT-106054, Biomet Orthopedics, Warsaw, IN. Intended Use: The Regenerex Ringloc is intended to replace
Terminated
LPHK070369
Jun 8, 2011Biomet, Inc.
Regenerex (TM) Ringloc +, Solid Acetablular Cup w/Apical Hole, 64 mm Size 26, w/Lock Ring w/Plug, sterile, REF PT-104064, Biomet Orthopedics, Warsaw, IN. Intended Use: The Regenerex Ringloc is intende
Terminated
LPHK070369
Jun 8, 2011Biomet, Inc.
Regenerex (TM) Ringloc +, Solid Acetablular Cup w/Apical Hole, 62 mm Size 25, w/Lock Ring w/Plug, sterile, REF PT-104062, Biomet Orthopedics, Warsaw, IN. Intended Use: The Regenerex Ringloc is intende
Terminated
LPHK070369
Jun 8, 2011Biomet, Inc.
Regenerex (TM) Ringloc +, Solid Acetablular Cup w/Apical Hole, 56 mm Size 24, w/Lock Ring w/Plug, sterile, REF PT-104056, Biomet Orthopedics, Warsaw, IN. Intended Use: The Regenerex Ringloc is intende
Terminated
LPHK070369
Jun 8, 2011Biomet, Inc.
Regenerex (TM) Ringloc +, Solid Acetablular Cup w/Apical Hole, 52 mm Size 23, w/Lock Ring w/Plug, sterile, REF PT-104052, Biomet Orthopedics, Warsaw, IN. Intended Use: The Regenerex Ringloc is intende
Terminated
LPHK070369
Jun 8, 2011Biomet, Inc.
Regenerex (TM) Ringloc +, Solid Acetablular Cup w/Apical Hole, 50 mm Size 22, w/Lock Ring w/Plug, sterile, REF PT-104050, Biomet Orthopedics, Warsaw, IN. Intended Use: The Porous Plasma Spray (PPS) R
Terminated
LPHK070369
Jun 8, 2011Biomet, Inc.
Regenerex (TM) Ringloc +, Limited Hole Acetablular Cup, 60 mm Size 25, with Locking Ring, sterile, REF PT-116060, Biomet Orthopedics, Warsaw, IN. Intended Use: The Regenerex Ringloc is intended to r
Terminated
LPHK070369
Jun 8, 2011Biomet, Inc.
Regenerex (TM) Ringloc +, Limited Hole Acetablular Cup, 56 mm Size 24, with Locking Ring, sterile, REF PT-116056, Biomet Orthopedics, Warsaw, IN. Intended Use: The Regenerex Ringloc is intended to r
Terminated
LPHK070369
Jun 8, 2011Biomet, Inc.
Regenerex (TM) Ringloc +, Limited Hole Acetablular Cup, 54 mm Size 23, with Locking Ring, sterile, REF PT-116054, Biomet Orthopedics, Warsaw, IN. Intended Use: The Regenerex Ringloc is intended to r
Terminated
LPHK070369
Jun 8, 2011Biomet, Inc.
Regenerex (TM) Ringloc +, Limited Hole Acetablular Cup, 52 mm Size 23, with Locking Ring, sterile, REF PT-116052, Biomet Orthopedics, Warsaw, IN. Intended Use: The Regenerex Ringloc is intended to re
Terminated
LPHK070369
Jun 8, 2011Biomet, Inc.
Regenerex (TM) Ringloc +, Limited Hole Acetablular Cup, 50 mm Size 22, with Locking Ring, sterile, REF PT-116050, Biomet Orthopedics, Warsaw, IN. Intended Use: The Regenerex Ringloc is intended to re
Terminated
LPHK070369
Jun 8, 2011Biomet, Inc.
Regenerex (TM) Ringloc +, Limited Hole Acetablular Cup, 48 mm Size 22, with Locking Ring, sterile, REF PT-116048, Biomet Orthopedics, Warsaw, IN. Intended Use: The Regenerex Ringloc is intended to r
Terminated
LPHK070369
Jun 8, 2011Biomet, Inc.
Regenerex (TM) Ringloc +, Multi Hole Acetablular Cup, 74 mm Size 28, with Lock Ring, sterile, REF PT-106074, Biomet Orthopedics, Warsaw, IN. Intended Use: The Regenerex Ringloc is intended to replace
Terminated
LPHK070369
Jun 8, 2011Biomet, Inc.
Regenerex (TM) Ringloc +, Multi Hole Acetablular Cup, 70 mm Size 27, with Lock Ring, sterile, REF PT-106070, Biomet Orthopedics, Warsaw, IN. Intended Use: The Regenerex Ringloc is intended to replace
Terminated
LPHK070369
Jun 8, 2011Biomet, Inc.
Regenerex (TM) Ringloc +, Multi Hole Acetablular Cup, 66 mm Size 26, with Lock Ring, sterile, REF PT-106066, Biomet Orthopedics, Warsaw, IN. Intended Use: The Regenerex Ringloc is intended to replace
Terminated
LPHK070369
Oct 14, 2010Zimmer Inc.
Zimmer Trabecular metal Modular Acetabular system 56 mm Porous shell with cluster holes, Catalog 00-6202-056-22, Zimmer Inc., Warsaw, IN. This device is indicated for primary or revision surgery for r
Terminated
LPHK021891
Aug 26, 2010Zimmer Inc.
VERSYS HIP SYSTEM FEMORAL HEAD 12/14 TAPER 28 MM DIA. -3.5 MM NECK LENGTH ZIMALOY CO-CR-MO ALLOY STERILE QTY-1 MANUFACTURED BY ZIMMER MANUFACTURING B.V., A SUBSIDIARY OF ZIMMER, INC. (WARSAW, IN) The
Terminated
LPHK953337
Aug 26, 2010Zimmer Inc.
VERSYS HIP SYSTEM FEMORAL HEAD 12/14 TAPER 32 MM DIA. -3.5 MM NECK LENGTH ZIMALOY CO-CR-MO ALLOY STERILE QTY-1 MANUFACTURED BY ZIMMER MANUFACTURING B.V., A SUBSIDIARY OF ZIMMER, INC. (WARSAW, IN) The
Terminated
LPHK953337
Aug 12, 2010Zimmer Inc.
Trabecular Metal acetabular revision system column buttress right posterior/left anterior, 00-4894-400-00, sterile, Zimmer Inc., Parsippany, NJ.
Terminated
LPHK061067
Aug 12, 2010Zimmer Inc.
Trabecular Metal acetabular revision system column buttress left posterior/right anterior, 00-4894-300-00, sterile, Zimmer Inc., Parsippany, NJ. Usage: Implantable devices that are used to address b
Terminated
LPHK061067
Aug 12, 2010Zimmer Inc.
Trabecular Metal acetabular revision system buttress augment size, 58, 00-4898-001-58, sterile, Zimmer Inc., Parsippany, NJ. Usage: Implantable devices that are used to address bony deficiencies of
Terminated
LPHK061067
Aug 12, 2010Zimmer Inc.
Trabecular Metal acetabular revision system buttress augment size, 54, 00-4898-001-54, sterile, Zimmer Inc., Parsippany, NJ. Usage: Implantable devices that are used to address bony deficiencies of
Terminated
LPHK061067
May 26, 2010Biomet, Inc.
19 mm Mallory Head Calcar 55 mm repl. femoral/100% porous 20.5 mm minimum ream dia. x 260 mm lt.., Sterile, REF CP154604, Biomet Orthopaedics, Warsaw, IN. Implant device intended for use in femo
Terminated
LPHK031693
May 26, 2010Biomet, Inc.
19 mm Mallory Head Calcar 45 mm repl. femoral/100% porous 20.5 mm minimum ream dia. x 260 mm rt., Sterile, REF CP154599, Biomet Orthopaedics, Warsaw, IN. Implant device intended for use in femor
Terminated
LPHK031693
May 26, 2010Biomet, Inc.
17 mm Mallory Head Calcar 55 mm repl. femoral/100% porous 18.5 mm minimum ream dia. x 220 mm rt., Sterile, REF CP154593, Biomet Orthopaedics, Warsaw, IN. Implant device intended for use in femor
Terminated
LPHK031693
May 26, 2010Biomet, Inc.
17 mm Mallory Head Calcar 45 mm repl. fmrl. /100% porous 18.5 mm minimum ream dia x 260 mm rt., Sterile, REF CP154591, Biomet Orthopaedics, Warsaw, IN. Implant device intended for use in femoral
Terminated
LPHK031693
May 26, 2010Biomet, Inc.
Mallory Head Calcar Femoral 55 mm resection/porous coated 15.0 mm x 220 mm left stem, Sterile, REF 11-104972, Biomet Orthopaedics, Warsaw, IN. Implant device intended for use in femoral revision
Terminated
LPHK031693

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