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 |
|---|---|---|---|
| Mar 11, 2014 | K133386 | OVATION TRIBUTE HIP STEM; OVATION NARROW HIP STEM Ortho Development Corp. | LPH |
| Mar 10, 2014 | K132959 | DEPUY PINNACLE ALTRX ACETABULAR LINERS DePuy Orthopaedics, Inc. | LPH |
| Feb 21, 2014 | K132158 | NOVOHIP TOTAL HIP SYSTEM Novosource, Inc. | LPH |
| Feb 12, 2014 | K131454 | KLASSIC HD(TM) EXTENDED OFFSET FEMORAL HEAD Total Joint Orthopedics, Inc. | LPH |
| Jan 22, 2014 | K132879 | MPACT EXTENSION Medacta International | LPH |
| Jan 17, 2014 | K133228 | ICONACY I-HIP SYSTEM, GRADUAL TRANSITIONING (GT) FEMORAL SYSTEM Iconacy Orthopedic Implants, LLC | LPH |
| Oct 16, 2013 | K131022 | OVATION 10/12 HIP STEM Ortho Development Corp. | LPH |
| Sep 19, 2013 | K132626 | PIPELINE TOTAL HIP SYSTEM (LINE EXTENSION) Pipeline Biotechnology | LPH |
| Aug 30, 2013 | K132207 | UTF STEM-REDUCED, ADDITIONAL SIZES United Orthopedic Corporation, TW | LPH |
| Aug 9, 2013 | K131279 | ICONACY I-HIP SYSTEM Iconacy Orthopedic Implants, LLC | LPH |
| Jul 1, 2013 | K130353 | PIPELINE TOTAL HIP SYSTEM (LINE EXTENSION) Pipeline Orthopedics | LPH |
| Jun 21, 2013 | K130099 | TAPERFILL FEMORAL HIP STEM 425-31-005_017 425-41-005_019 Encore Medical L.P. | LPH |
| Jun 13, 2013 | K131237 | PIPELINE TOTAL HIP SYSTEM Pipeline Orthopedics | LPH |
| Jun 6, 2013 | K130149 | U2 HIP SYSTEM, EXPANDED INDICATIONS FOR USE United Orthopedic Corporation, TW | LPH |
| May 1, 2013 | K123550 | UTF STEM, REDUCED United Orthopedic Corporation, TW | LPH |
| Apr 30, 2013 | K120599 | DEPUY M-SPEC 36MM FEMORAL HEADS Depuy Orthopaedics | LPH |
| Apr 19, 2013 | K130063 | ARCOS TROCHANTER BUTTON Biomet, Inc. | LPH |
| Dec 28, 2012 | K121297 | ORIGIN HIP STEM, FEMORAL HEAD, LOGICAL PX-SERIES ACETABULAR SHELL, LOCIGAL G-SERIES ACETABULAR SHELL, LOGICAL ACETABULAR Signature Orthopaedics Pty, Ltd., AT | LPH |
| Dec 21, 2012 | K112898 | DELTA TT CUPS, DELTA TT LINERS, BONE SCREWS Lima Corporate S.P.A. | LPH |
| Nov 5, 2012 | K122512 | CS2 HIP SYSTEM Consensus Orthopedics, Inc. | LPH |
| Nov 2, 2012 | K122636 | REVELATION POROUS COATED HIP STEM, SIZE 8 Encore Medical L.P. | LPH |
| Oct 24, 2012 | K123012 | SMITH & NEPHEW SMF HIP STEM Smith & Nephew, Inc. | LPH |
| Oct 24, 2012 | K121636 | ZENITH, FEMORAL STEM ZENITH, DISTAL CENTRALIZER FOMORAL HEAD ACETABULAR INSERT Tgm Medical, Inc. | LPH |
| Oct 22, 2012 | K123019 | LONGEVITY IT HIGHLY CROSSLINKED POLYETHYENE LINERS Zimmer, Inc. | LPH |
| Oct 11, 2012 | K122798 | INTEGRIP ACETABULAR SHELL, INTEGRIP REVISION ACETABULAR SHELL Exactech, Inc. | LPH |
| Oct 10, 2012 | K122504 | FEMORAL HEADS, 2.5 AND 7.5 MM NECK LENGTH United Orthopedic Corporation, TW | LPH |
| Oct 5, 2012 | K122099 | BENCOX II STEM, BENCOX METAL HEAD Corentec Co., Ltd., KR | LPH |
| Oct 1, 2012 | K121684 | NOVATION LPI PRIME FEMORAL STEM Exactech, Inc. | LPH |
| Sep 14, 2012 | K113296 | ZMR HIP SYSTEM KWZ-PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER Zimmer, Inc. | LPH |
| Sep 10, 2012 | K121935 | TAPERSET HIP SMALL STEMS Consensus Orthopedics, Inc. | LPH |
| Sep 10, 2012 | K120924 | BENCOX MIRABO CUP BENCOX MIRABO INSERT (STANDARD& ELEVATED TYES) BENCOX MIRABO CUP SCREW HOLE PLUG Corentec Co., Ltd., KR | LPH |
| Sep 4, 2012 | K121034 | IOI TOTAL HIP Iconacy Orthopedic Implants, LLC | LPH |
| Aug 23, 2012 | K122244 | POLARCUP DUAL MOBILITY SYSTEM Smith & Nephew, Inc. | LPH |
| Aug 17, 2012 | K120030 | TAPERLOC COMPLETE SIZE 4MM AND XR 123 Biomet Manufacturing Corp | LPH |
| Jul 30, 2012 | K121308 | HIP SYSTEMS Howmedica Osteonics Corp. | LPH |
| Jul 18, 2012 | K121777 | U2 ACETABULAR CUP, PLASMA SPRAY United Orthopedic Corp., TW | LPH |
| Jun 19, 2012 | K121024 | LINEAR POROUS COATED HIP STEM, SIZE 5; REVELATION HIP STEM, SIZE 8; FOUNDATION POROUS PRESS FIT STEM, SIZE 8; Encore Medical L.P. | LPH |
| May 22, 2012 | K121263 | TAPER SET HIP SYSTEM RDP STEM Consensus Orthopedics, Inc. | LPH |
| May 10, 2012 | K112158 | MODULUS STEMS, MODULUS NECKS, MODULAR FEMORAL HEADS, CEMENTED CUPS, LOCK BIPOLAR HEADS Lima Corporate S.P.A. | LPH |
| Feb 24, 2012 | K120241 | LINEAR HIP STEM, SIZE 5 Encore Medical L.P. | LPH |
| Jan 5, 2012 | K113242 | APEX ARC HIP STEM Omni Life Science, Inc. | LPH |
| Jan 4, 2012 | K113609 | NOVATION INTEGRIP ACETABULAR AUGMENTS, GROUPS 4 AND 5 Exactech, Inc. | LPH |
| Dec 2, 2011 | K112779 | APEX MODULAR ACCTABULAR CUP (NOW NAMED APEX INTERFACE ACETABULAR SYSTEM) Omnlife Science | LPH |
| Oct 14, 2011 | K110135 | POLARCUP DUAL MOBILITY SYSTEM Smith & Nephew, Inc. | LPH |
| Sep 6, 2011 | K111472 | HELICON HIP SYSTEM, FEMORAL STEM, HELICON HIP SYSTEM, FEMORAL HEAD, COCR, HELICON HIP SYSTEM, ACETABULAR SHELL, HELICON Tgm Medical | LPH |
| Aug 4, 2011 | K110245 | UNITED UTF STEM United Orthopedic Corporation, TW | LPH |
| Jul 21, 2011 | K103431 | COREN TOTAL HIP SYSTEM Corentec Co., Ltd. | LPH |
| Jul 1, 2011 | K111546 | U2 HIP SYSTEM United Orthopedic Corp., TW | LPH |
| Jun 16, 2011 | K110947 | APEX K1 HIP STEM Omni Life Science, Inc. | LPH |
| Apr 15, 2011 | K103662 | CONTINUUM AND TRILOGY INTEGRATED TAPER (IT) ACETABULAR SYSTEMS; LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE ELEVATED LI Zimmer, Inc. | LPH |
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