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 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 11, 2011 | K101072 | TRITANIUM PERI-APATITIE ACETABULAR SOLID-BACKED SHELL, TRITANIUM PERI-APATITE Howmedica Osteonics Corp. | LPH |
| Apr 1, 2011 | K110542 | CONSENSUS BIOLOX DELTA CERAMIC FEMORAL HEAD Consensus Orthopedics, Inc. | LPH |
| Mar 24, 2011 | K110555 | ARCOMXL ACTIVE ARTICULATION Biomet Manufacturing Corp | LPH |
| Mar 21, 2011 | K103721 | MPACT ACETABULAR SYSTEM Medacta International | LPH |
| Mar 16, 2011 | K103384 | ESCALADE ACETABULAR CUP SYSTEM Ortho Development | LPH |
| Mar 3, 2011 | K102019 | RESTORATION ACETABULAR WEDGE AUGMENTS Howmedica Osteonics | LPH |
| Jan 31, 2011 | K103256 | SMITH & NEPHEW SMF HIP STEM Smith & Nephew, Inc. | LPH |
| Jan 14, 2011 | K101336 | E1 AVANTAGE HEAD Biomet Manufacturing Corp | LPH |
| Dec 3, 2010 | K101229 | LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE ELEVATED LINERS, CONTINUUM ACETABULAR SYSTEM AND TRILOGY INTEGRATED TAPER Zimmer, Inc. | LPH |
| Dec 3, 2010 | K100445 | KLASSIC HD HIP SYSTEM Total Joint Orthopedics, Inc. | LPH |
| Dec 2, 2010 | K102399 | CONSENSUS TAPERSET HIP SYSTEM Consensus Orthopedics, Inc. | LPH |
| Nov 19, 2010 | K103124 | SERIES II X3 LARGE DIAMETER ACCETABULAR INSERTS Stryker Corporation | LPH |
| Nov 5, 2010 | K102975 | NOVATION CROWN CUP WITH INTEGRIP ACETABULAR SHELL, CLUSTER-HOLE Exactech, Inc. | LPH |
| Oct 29, 2010 | K102423 | DEPUY PINNACLE ALTRX ACETABULAR LINERS DePuy Orthopaedics, Inc. | LPH |
| Oct 6, 2010 | K100933 | CONSENSUS CS2 PLUS ACETABULAR INSERT Consensus Orthopedics, Inc. | LPH |
| Sep 21, 2010 | K101761 | EXACTECH NOVATION EMPIRE ACETABULAR AUGMENT WITH INTEGRIP MODEL 186-01-08/11/13, 186-02-08/11/13, 186-03-08/11/13 Exactech, Inc. | LPH |
| Sep 14, 2010 | K101976 | INTERFACE ACETABULAR SYSTEM, ACETABULAR INSERT +4 OFFSET Omni Life Science, Inc. | LPH |
| Jun 30, 2010 | K101575 | APEX MODULAR HEAD, SIZE 28 ,32, 26 AND 40 MM+10.5 OFFSET, MODELS 302810, 303210,303610,304010 Omnlife Science | LPH |
| May 27, 2010 | K100269 | NOVATION CROWN CUP GXL LINERS Exactech, Inc. | LPH |
| Apr 28, 2010 | K093561 | ZIMMER TRABECULAR METAL MODULAR ACETABULAR SYSTEM Zimmer, Inc. | LPH |
| Apr 22, 2010 | K094045 | MODIFICAITON TO: CARDO MEDICAL HIP SYSTEM Cardo Medical Corp. | LPH |
| Mar 29, 2010 | K100555 | APEX-LNK ACETABULAR INSERT, E, APEX-LNK ACETABULAR INSERT, F, APEX-LNK Omni Life Science, Inc. | LPH |
| Jan 22, 2010 | K092098 | PATIENT SPECIFIC ACETABULAR RECONSTRUCTION PROSTHESIS Smith & Nephew, Inc. | LPH |
| Oct 23, 2009 | K092443 | INTERFACE ACETABULAR CUP LINERS Omni Life Science, Inc. | LPH |
| Oct 23, 2009 | K090897 | TRITANIUM NON-MODULAR SHELL & X3 ALL-POLY INSERT Howmedica Osteonics Corp. | LPH |
| Sep 11, 2009 | K091508 | ZIMMER CONTINUUM ACETABULAR SYSTEM, ZIMMER TRILOGY IT ACETABULAR SYSTEM Zimmer, Inc. | LPH |
| Aug 21, 2008 | K081566 | SMITH & NEPHEW OXINIUM DH FEMORAL HEADS Smith & Nephew, Inc. | LPH |
| Aug 20, 2008 | K081679 | REVELATION HIP STEM, MODELS, 427-01, 427-02; LINEAR HIP STEM, MODELS 425-00, 425-05 Encore Medical L.P. | LPH |
| Jul 22, 2008 | K081171 | TRITANIUM ACETABULAR SHELL SYSTEM Howmedica Osteonics Corp. | LPH |
| May 15, 2008 | K072817 | ECHELON TITANIUM HIP SYSTEM Smith & Nephew, Inc. | LPH |
| May 8, 2008 | K080625 | SMITH & NEPHEW MIS HIP STEM WITH STIKTITE Smith & Nephew, Inc. | LPH |
| Feb 27, 2008 | K073150 | APEX-LNK POLY ACETABULAR CUP LINERS Omni Life Science, Inc. | LPH |
| Jan 10, 2008 | K073068 | ACCIN HIP SYSTEM Accelerated Innovation, LLC | LPH |
| Jan 10, 2008 | K072888 | REVELATION AND LINEAR HIP STEMS AND FMP ACETABULAR SHELLS (SPIKED, HEMISPHERICAL AND FLARED) Encore Medical L.P. | LPH |
| Jan 10, 2008 | K072417 | SMITH & NEPHEW MIS HIP STEM Smith & Nephew, Inc. | LPH |
| Jan 9, 2008 | K072963 | DEPUY PINNACLE ALTRX ACETABULAR LINERS DePuy Orthopaedics, Inc. | LPH |
| Dec 14, 2007 | K072154 | FOUNDATION (FMP) POROUS COATED SPIKED ACETABULAR SYSTEM Encore Medical L.P. | LPH |
| Nov 19, 2007 | K072101 | RIGI-FIX HIP STEM SYSTEM Implants Intl. , Ltd., GB | LPH |
| Oct 5, 2007 | K071160 | REFLECTION, TANDEM UNIPOLAR Smith & Nephew, Inc. | LPH |
| Aug 15, 2007 | K062489 | APEX HCLA ACETABULAR CUP LINERS Omnilife Science | LPH |
| Jul 25, 2007 | K071784 | DEPUY PINNACLE WITH GRIPTON ACETABULAR CUPS DePuy Orthopaedics, Inc. | LPH |
| May 23, 2007 | K070050 | VITALITY HIP SYSTEM MODEL#420 Encore Medical L.P. | LPH |
| Apr 16, 2007 | K070278 | POLARCUP DUAL MOBILITY SYSTEM Plus Orthopedics AG | LPH |
| Mar 9, 2007 | K070369 | REGENERX RINGLOC + MODULAR ACETABULAR SHELLS Biomet, Inc. | LPH |
| Jan 25, 2007 | K063822 | MODIFICATION TO HIPSTAR FEMORAL STEM Stryker Orthopaedics | LPH |
| Jan 16, 2007 | K062775 | EUROPEAN STYLE TAPER,PRESS-FIT HIP STEM Ortho Development Corp. | LPH |
| Dec 20, 2006 | K061461 | MAYO CONSERVATIVE HIP PROSTHESIS, MODEL 00.65-8026-010-05 Zimmer, Inc. | LPH |
| Nov 22, 2006 | K063257 | FMP COATED SPIKED ACETABULAR CUP; HEMISPHERICAL ACETABULAR CUP; FLARED RIM ACETABULAR CUP; METAL/METAL ACETABULAR INSERT Encore Medical L.P. | LPH |
| Nov 15, 2006 | K062419 | TRIDENT LARGE DIAMETER ACETABULAR INSERTS Howmedica Osteonics Corp. | LPH |
| Oct 24, 2006 | K062148 | DEPUY PINNACLE ALTRX ACETABULAR CUP LINER DePuy Orthopaedics, Inc. | LPH |
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