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)
Top companies in LPH
| Company | 510(k)s | Recalls |
|---|---|---|
| Zimmer GmbH | 46 | 56 |
| Biomet, Inc. | 44 | 43 |
| DePuy Orthopaedics, Inc. | 33 | 23 |
| Zimmer Biomet | 1 | 48 |
| Howmedica Osteonics | 16 | 31 |
| Exactech, Inc. | 19 | 26 |
| Smith & Nephew, Inc. | 32 | 4 |
| Depuy, Inc. | 24 | 0 |
| Encore Medical L.P. | 13 | 11 |
| Howmedica Corp. | 18 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 20, 2012 | DePuy 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 |
LPH | K060581 |
| Dec 20, 2012 | DePuy 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 |
LPH | K060581 |
| Dec 20, 2012 | DePuy 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 |
LPH | K060581 |
| Dec 20, 2012 | DePuy 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 |
LPH | K060581 |
| Dec 20, 2012 | DePuy 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 |
LPH | K060581 |
| Dec 20, 2012 | DePuy 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 |
LPH | K060581 |
| Dec 19, 2012 | DePuy 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 |
LPH | K000306 |
| Nov 21, 2012 | Zimmer, 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 |
LPH | None listed |
| Oct 31, 2012 | Wright 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 |
LPH | K003016 K021346 +4 |
| Oct 31, 2012 | Wright 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 |
LPH | K003016 K021346 +4 |
| Oct 31, 2012 | Wright 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 |
LPH | K003016 K021346 +4 |
| Aug 17, 2012 | DePuy 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 |
LPH | K102423 |
| Dec 1, 2011 | Zimmer 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 |
LPH | K031572 K994286 |
| Dec 1, 2011 | Zimmer 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 |
LPH | K031572 K994286 |
| Dec 1, 2011 | Zimmer 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 |
LPH | K031572 K994286 |
| Dec 1, 2011 | Zimmer 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 |
LPH | K031572 K994286 |
| Nov 16, 2011 | Zimmer 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 |
LPH | K994286 |
| Nov 16, 2011 | Zimmer 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 |
LPH | K994286 |
| Nov 16, 2011 | Zimmer 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 |
LPH | K051491 |
| Jun 8, 2011 | Biomet, 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 |
LPH | K070369 |
| Jun 8, 2011 | Biomet, 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 |
LPH | K070369 |
| Jun 8, 2011 | Biomet, 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 |
LPH | K070369 |
| Jun 8, 2011 | Biomet, 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 |
LPH | K070369 |
| Jun 8, 2011 | Biomet, 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 |
LPH | K070369 |
| Jun 8, 2011 | Biomet, 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 |
LPH | K070369 |
| Jun 8, 2011 | Biomet, 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 |
LPH | K070369 |
| Jun 8, 2011 | Biomet, 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 |
LPH | K070369 |
| Jun 8, 2011 | Biomet, 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 |
LPH | K070369 |
| Jun 8, 2011 | Biomet, 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 |
LPH | K070369 |
| Jun 8, 2011 | Biomet, 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 |
LPH | K070369 |
| Jun 8, 2011 | Biomet, 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 |
LPH | K070369 |
| Jun 8, 2011 | Biomet, 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 |
LPH | K070369 |
| Jun 8, 2011 | Biomet, 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 |
LPH | K070369 |
| Jun 8, 2011 | Biomet, 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 |
LPH | K070369 |
| Jun 8, 2011 | Biomet, 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 |
LPH | K070369 |
| Jun 8, 2011 | Biomet, 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 |
LPH | K070369 |
| Jun 8, 2011 | Biomet, 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 |
LPH | K070369 |
| Jun 8, 2011 | Biomet, 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 |
LPH | K070369 |
| Oct 14, 2010 | Zimmer 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 |
LPH | K021891 |
| Aug 26, 2010 | Zimmer 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 |
LPH | K953337 |
| Aug 26, 2010 | Zimmer 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 |
LPH | K953337 |
| Aug 12, 2010 | Zimmer Inc. Trabecular Metal acetabular revision system column buttress right posterior/left anterior, 00-4894-400-00, sterile, Zimmer Inc., Parsippany, NJ. Terminated |
LPH | K061067 |
| Aug 12, 2010 | Zimmer 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 |
LPH | K061067 |
| Aug 12, 2010 | Zimmer 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 |
LPH | K061067 |
| Aug 12, 2010 | Zimmer 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 |
LPH | K061067 |
| May 26, 2010 | Biomet, 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 |
LPH | K031693 |
| May 26, 2010 | Biomet, 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 |
LPH | K031693 |
| May 26, 2010 | Biomet, 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 |
LPH | K031693 |
| May 26, 2010 | Biomet, 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 |
LPH | K031693 |
| May 26, 2010 | Biomet, 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 |
LPH | K031693 |
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