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 |
|---|---|---|---|
| Oct 3, 2017 | K172684 | Smith & Nephew, Inc. ANTHOLOGY AFIT Hip Stem Smith & Nephew, Inc. | LPH |
| Oct 2, 2017 | K171768 | Trident® II Acetabular System Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics | LPH |
| Sep 21, 2017 | K172501 | iNSitu Total Hip System Theken Companies, LLC | LPH |
| Jul 24, 2017 | K171962 | Klassic HD® Hip System Total Joint Othopedics, Inc. | LPH |
| Jul 17, 2017 | K162957 | U2 Femoral Head United Orthopedic Corporation, TW | LPH |
| Jun 26, 2017 | K170444 | PROCOTYL® PRIME Acetabular Cup System Microport Orthopedics, Inc. | LPH |
| Jun 14, 2017 | K162719 | iTotal® Hip Replacement System Conformis, Inc. | LPH |
| Jun 8, 2017 | K163193 | UTF Stem, reduced, #0, #00 United Orthopedic Corporation, TW | LPH |
| Dec 5, 2016 | K162127 | Bencox M Stem Lateralized & Bencox Mirabo Cup System Corentec Co., Ltd., KR | LPH |
| Oct 19, 2016 | K161073 | Klassic HD Hip System Total Joint Othopedics, Inc. | LPH |
| Oct 14, 2016 | K161569 | Trident® II Tritanium® Acetabular Shells and 6.5 mm Low Profile Hex Screws Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics | LPH |
| Oct 14, 2016 | K161184 | iNSitu Total Hip System Theken Companies, LLC | LPH |
| Jul 27, 2016 | K151424 | The Progressive Orthopaedic Total Hip System The Progressive Orthopaedic Company, LLC | LPH |
| May 26, 2016 | K161190 | G7 Dual Mobility System, Active Articulation System Biomet, Inc. | LPH |
| May 25, 2016 | K153345 | Stryker Orthopaedics Hip Systems Labeling Update Stryker Orthopaedics | LPH |
| May 17, 2016 | K161080 | Escalade Legend Acetabular Shell Ortho Development Corporation | LPH |
| Apr 29, 2016 | K152084 | Bencox M Stem (Bencox Hip System) and Bencox ID Cemented Stem (with Centralizer) & Bencox Bone Plug Corentec Co., Ltd., KR | LPH |
| Apr 8, 2016 | K160266 | ICONACY(TM) I-Hip(TM) Iconacy Orthopedic Implants, LLC | LPH |
| Nov 16, 2015 | K150790 | REDAPT Porous Acetabular Shell and Cemented Liner Smith & Nephew, Inc. | LPH |
| Oct 6, 2015 | K151603 | Arcos One-piece Femoral Revision System Biomet, Inc. | LPH |
| Sep 3, 2015 | K151440 | Klassic HD Hip System Total Joint Orthopedics, Inc. | LPH |
| Sep 3, 2015 | K141960 | Exactech® Novation® Crown Cup® Exactech, Inc. | LPH |
| Aug 13, 2015 | K151448 | Continuum and Trilogy Integrated Taper (IT) Acetabular Systems Zimmer, Inc. | LPH |
| Aug 13, 2015 | K151316 | U2 Hip Stem, Ti Porous Coated, Matrix United Orthopedic Corporation, TW | LPH |
| Aug 10, 2015 | K151264 | Restoration Anatomic Shell Stryker Orthopaedics | LPH |
| May 4, 2015 | K150007 | Modified Bencox Hip System Corentec Co., Ltd., KR | LPH |
| May 1, 2015 | K150522 | G7 Dual Mobility System Biomet, Inc. | LPH |
| Mar 25, 2015 | K150503 | Echo Bi-Metric Microplasty Line Extension Biomet, Inc. | LPH |
| Mar 2, 2015 | K143453 | Mpact Double Mobility System Medacta International, CH | LPH |
| Feb 27, 2015 | K143314 | Progressive Orthopaedic Total Hip System The Progressive Orthopaedic Company, LLC | LPH |
| Feb 27, 2015 | K142119 | PROCOTYL L-O ACETABULAR SYSTEM Microport Orthopedics, Inc. | LPH |
| Feb 10, 2015 | K142882 | G7 Freedom and Offset Liners, Freedom Head, Size 32 Biomet, Inc. | LPH |
| Feb 9, 2015 | K143085 | Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip Instruments for use with the Direct Superior Approac Stryker Orthopaedics | LPH |
| Jan 26, 2015 | K142606 | Trident® Tritanium® PST® Acetabular Shells Mako Surgical Corp. | LPH |
| Jan 26, 2015 | K142201 | OMNI Interface Acetabular System Omnlife Science | LPH |
| Jan 22, 2015 | K140547 | EXCERA FITRITE TOTAL HIP ARTHROPLASTY SYSTEM Excera Orthopedics, Inc. | LPH |
| Dec 29, 2014 | K142746 | G7 Finned Acetabular Shell Biomet Manufactuting Corp. | LPH |
| Dec 18, 2014 | K143009 | Echo Bi-Metric Microplasty Hip System Biomet, Inc. | LPH |
| Dec 11, 2014 | K140669 | G7 OSSEOTI ACETUBLAR SHELLS Biomet, Inc. | LPH |
| Nov 14, 2014 | K142462 | Restoration Anatomic Shell Stryker Orthopaedics | LPH |
| Nov 4, 2014 | K141676 | RENOVIS SURGICAL POROUS ACETABULAR CUP SYSTEM Renovis Surgical Technologies, Inc. | LPH |
| Jul 30, 2014 | K141001 | ALPINE HIP STEM; ALPINE HA HIP STEM Ortho Development | LPH |
| Jul 29, 2014 | K141797 | ALTEON 6.5MM BONE SCREWS Exactech, Inc. | LPH |
| Jul 22, 2014 | K133370 | REMEDY HIP STEM, PEGASUS HIP STEM, EVOLVE HELIOS HIP STEM, EVOLVE MASTERS HIP STEM, EVOLVE DISTAL CENTRALIZER, EVOLVE CE Signature Orthopaedics Pty Limited, AU | LPH |
| Jun 30, 2014 | K141395 | DELTA TT ACETABULAR SYSTEM Lima Corporate S.P.A., IT | LPH |
| Jun 20, 2014 | K132697 | ENCOMPASS 10/12 HIP STEM Ortho Development Corp. | LPH |
| May 19, 2014 | K141043 | CS2 MULTI-HOLE ACETABULAR SHELL Consensus Orthopedics, Inc. | LPH |
| Apr 11, 2014 | K132312 | RENOVIS TESERA TRABECULAR TECHNOLOGY (T3) ACETABULAR SHELL SYSTEM Renovis Surgical Technologies, LLC | LPH |
| Mar 28, 2014 | K132572 | I-HIP TOTAL HIP SYSTEM Iconacy Orthopedic Implants, LLC | LPH |
| Mar 13, 2014 | K133832 | KLASSIC HD HIP SYSTEM, OFFSET FEMORAL STEM, NON-POROUS / POROUS Total Joint Orthopedics, Inc. | LPH |
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