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) |
|---|---|---|---|
| May 26, 2010 | Biomet, Inc. Mallory Head Calcar Femoral, 55 mm resection/porous coated, 15.0 mm x 220 mm right stem, Sterile, REF 11-104971, Biomet Orthopaedics, Warsaw, IN.
Implant device intended for use in femoral rev Terminated |
LPH | K031693 |
| May 26, 2010 | Biomet, Inc. Mallory Head Calcar Femoral, 34 mm resection/porous coated, 15.0 mm x 220 mm left stem, Sterile, REF 11-104954, Biomet Orthopaedics, Warsaw, IN.
Implant device intended for use in femoral revis Terminated |
LPH | K031693 |
| May 26, 2010 | Biomet, Inc. Mallory Head Calcar Femoral, 34 mm resection/porous coated, 15.0 mm x 220 mm right stem, Sterile, REF 11-104953, Biomet Orthopaedics, Warsaw, IN.
Implant device intended for use in femoral revi Terminated |
LPH | K031693 |
| May 26, 2010 | Biomet, Inc. Mallory Head Calcar Femoral, 34 mm resection/porous coated, 9.0 mm x 220 mm right stem, Sterile, REF 11-104947, Biomet Orthopaedics, Warsaw, IN.
Implant device intended for use in femoral revis Terminated |
LPH | K031693 |
| May 26, 2010 | Biomet, Inc. Mallory Head Calcar Provisional, 55 mm resection/porous coated, 17.0 mm x 260 mm left, Sterile, REF 11-104939, Biomet Orthopaedics, Warsaw, IN.
Implant device intended for use in femoral revisi Terminated |
LPH | K031693 |
| May 26, 2010 | Biomet, Inc. Mallory Head Calcar Femoral, 34 mm resection/porous coated, 15.0 mm x 170 mm stem, Sterile, REF 11-104905, Biomet Orthopaedics, Warsaw, IN.
Implant device intended for use in femoral revision s Terminated |
LPH | K031693 |
| May 26, 2010 | Biomet, Inc. Mallory Head Calcar Femoral, 34 mm resection/porous coated, 13.0 x 170 mm,, Sterile, REF 11-104904, Biomet Orthopaedics, Warsaw, IN.
Implant device intended for use in femoral revision surgery. Terminated |
LPH | K031693 |
| May 26, 2010 | Biomet, Inc. Mallory Head Calcar Femoral, 34 mm resection/porous coated, 9mm x 170 mm stem, Sterile, REF 11-104902, Biomet Orthopaedics, Warsaw, IN.
Implant device intended for use in femoral revision surge Terminated |
LPH | K031693 |
| May 26, 2010 | Biomet, Inc. Mallory Head Calcar Provisional, 45 mm replacement stem, 13.0 x 220 mm left, Sterile, REF 104986, Biomet Orthopaedics, Warsaw, IN.
Implant device intended for use in femoral revision surgery. Terminated |
LPH | K031693 |
| May 26, 2010 | Biomet, Inc. Mallory Head Calcar Provisional, 34 mm replacement stem, 11 mm x 220 mm left, Sterile, REF 104773, Biomet Orthopaedics, Warsaw, IN.
Implant device intended for use in femoral revision surgery. Terminated |
LPH | K031693 |
| Mar 2, 2010 | Stryker Howmedica Osteonics Corp. Trident Acetabular Hip System Polyethylene Inserts, Stryker Orthopaedics, multiple sizes, Mahwah, NJ.
Intended for use in cementless fixation fro use in total hip arthroplasty to relieve pain and res Terminated |
LPH | K033716 |
| Nov 13, 2009 | Zimmer Inc. Zimmer VerSys Hip System Femoral Head, 12/14 taper, 28 mm dia., neck length +0 mm, sterile, Zimmer, Warsaw, IN; REF 8018-28-02.
Intended for mating femoral stems equipped with tapered necks. Terminated |
LPH | K953337 |
| Jul 27, 2009 | Zimmer Inc. Zimmer Kinectivo Technology Modular Neck, BB, 12/14 neck taper, sterile, Zimmer, Warsaw, IN; Catalog Number: 00-7848-022-01.
Orthopedic implant used in total hip arthroplasty. Terminated |
LPH | K063251 |
| Apr 21, 2009 | Smith & Nephew Inc Reflection, Microstable Acetabular Liner, REF 71740250, 32mm ID, 50-52 OD, 1 each, sterile EO. Component is a liner used to hold the femoral head used in total hip replacement arthroplasty procedures Terminated |
LPH | K991026 |
| Mar 19, 2008 | Zimmer Inc. Zimmer Trilogy Acetabular System Shell with Cluster Holes, Porous, 60mm O.D., Tivanium TI-6AL-4V Alloy, Hip Prosthesis Component, REF 6200-060-22, Catalog # 00-6200-060-22, Zimmer, Inc., Warsaw, IN, Terminated |
LPH | K934765 |
| Mar 12, 2008 | Exactech, Inc. Exactech 12/14 Biolox Alumina Femoral Head 28MM +3.5, hip prosthesis component, Exactech, Gainesville, FL 32653 Terminated |
LPH | K032964 |
| Dec 14, 2007 | Stryker Howmedica Osteonics Corp. Hipstar V40 Femoral Stem-127 degrees; N degrees 3 high offset 31 mm;Sterile; Catalog No: 7850-5-012, IMPLANT SIZE 12, Howmedica,Benoist Girard dt Cie, 203 bd de la Grande Della B.P.8;14291 Herouville Terminated |
LPH | None listed |
| Dec 14, 2007 | Stryker Howmedica Osteonics Corp. Hipstar V40 Femoral Stem-127 degrees; N degrees 3 high offset 31 mm;Sterile; Catalog No: 7850-5-011, IMPLANT SIZE 11 , Howmedica,Benoist Girard dt Cie, 203 bd de la Grande Della B.P.8;14291 Herouville Terminated |
LPH | None listed |
| Dec 14, 2007 | Stryker Howmedica Osteonics Corp. Hipstar V40 Femoral Stem-127 degrees; N degrees 3 high offset 31 mm;Sterile; Catalog No: 7850-5-010, IMPLANT SIZE 10, Howmedica,Benoist Girard dt Cie, 203 bd de la Grande Della B.P.8;14291 Herouville Terminated |
LPH | None listed |
| Dec 14, 2007 | Stryker Howmedica Osteonics Corp. Hipstar V40 Femoral Stem-127 degrees; N degrees 3 high offset 31 mm;Sterile; Catalog No: 7850-5-009, IMPLANT SIZE 9, Howmedica,Benoist Girard dt Cie, 203 bd de la Grande Della B.P.8;14291 Herouville S Terminated |
LPH | None listed |
| Dec 14, 2007 | Stryker Howmedica Osteonics Corp. Hipstar V40 Femoral Stem-127 degrees; N degrees 3 high offset 31 mm;Sterile; Catalog No: 7850-5-008, IMPLANT SIZE 8 , Howmedica,Benoist Girard dt Cie, 203 bd de la Grande Della B.P.8;14291 Herouville Terminated |
LPH | None listed |
| Dec 14, 2007 | Stryker Howmedica Osteonics Corp. Hipstar V40 Femoral Stem-127 degrees; N degrees 3 high offset 31 mm;Sterile; Catalog No: 7850-5-007, IMPLANT SIZE 7, Howmedica, Benoist Girard dt Cie, 203 bd de la Grande Della B.P.8;14291 Herouville Terminated |
LPH | None listed |
| Dec 14, 2007 | Stryker Howmedica Osteonics Corp. Hipstar V40 Femoral Stem 127 degrees; N degrees 3 high offset 31 mm;Sterile; Catalog No: 7850-5-006, IMPLANT SIZE 6 , Howmedica,Benoist Girard dt Cie, 203 bd de la Grande Della B.P.8;14291 Herouville Terminated |
LPH | None listed |
| Dec 14, 2007 | Stryker Howmedica Osteonics Corp. Hipstar V40 Femoral Stem-127 degrees; N degrees 3 high offset 31 mm;Catalog No: 7850-5-005, IMPLANT SIZE 5, Sterile; Howmedica,Benoist Girard dt Cie, 203 bd de la Grande Della B.P.8;14291 Herouville S Terminated |
LPH | None listed |
| Dec 14, 2007 | Stryker Howmedica Osteonics Corp. Hipstar V40 Femoral Stem 127 degrees; N degrees 3 high offset 31 mm;Catalog No: 7850-5-004, IMPLANT SIZE 4 , Sterile; Howmedica,Benoist Girard dt Cie, 203 bd de la Grande Della B.P.8;14291 Herouville Terminated |
LPH | None listed |
| Dec 14, 2007 | Stryker Howmedica Osteonics Corp. Hipstar V40 Femoral Stem-127 degrees; N degrees 3 high offset 31 mm; Catalog No:7850-5-003, IMPLANT SIZE 3,Sterile;
Howmedica,Benoist Girard dt Cie, 203 bd de la Grande Della B.P.8;14291 Herouville Sa Terminated |
LPH | None listed |
| Dec 14, 2007 | Stryker Howmedica Osteonics Corp. Hipstar V40 Femoral Stem-127 degrees; N degrees 3 high offset 31 mm; Catalog No: 7850-5-002 ,IMPLANT SIZE 2 ,Sterile; Howmedica,Benoist Girard dt Cie, 203 bd de la Grande Della B.P.8;14291 Herouville Terminated |
LPH | None listed |
| Dec 14, 2007 | Stryker Howmedica Osteonics Corp. Hipstar TMZF Cementless Hip Stem Protocol, Product Number: LSP60. Terminated |
LPH | None listed |
| Dec 14, 2007 | Stryker Howmedica Osteonics Corp. Hipstar V40 Femoral Stem-127 degrees; Catalog No: 7850-5-001, N degrees 3 high offset 31 mm;Sterile; IMPLANT SIZE 1, Howmedica,Benoist Girard dt Cie, 203 bd de la Grande Della B.P.8;14291 Herouville Terminated |
LPH | K063822 |
| Oct 27, 2007 | Biomet, Inc. Biomet Orthopedics Apical Hole Plug, 3/8 - 24 threaded, TI-6AL-4V alloy, sterile; REF 123741, Biomet Orthopedics, Inc., Warsaw, IN 46581 Terminated |
LPH | None listed |
| Jun 9, 2007 | Exactech, Inc. AcuMatch M-Series Straight Fluted Stem Segment and AcuMatch M-Series Curved Fluted Stem Segment. Catalog numbers 150-07-19 and 150-07-44. Terminated |
LPH | K993736 |
| Aug 31, 2006 | Zimmer Inc. Zimmer ZMR Hip System femoral body, revision, nitrided, porous, 12/14 neck taper, standard, 40 mm neck offset, cone body, size F, 35 mm build-up, tivanium TI-6AL-4V alloy, sterile; REF. 9996-23-35 (Ca Terminated |
LPH | K994286 |
| Aug 31, 2006 | Zimmer Inc. Zimmer ZMR Hip System femoral body, revision, nitrided, porous, 12/14 neck taper, standard, 40 mm neck offset, cone body, size C, 45 mm build-up, tivanium TI-6AL-4V alloy, sterile; REF. 9996-19-45 (Ca Terminated |
LPH | K994286 |
| Aug 31, 2006 | Zimmer Inc. Zimmer ZMR Hip System femoral body, revision, nitrided, porous, 12/14 neck taper, standard, 40 mm neck offset, cone body, size C, 35 mm build-up, tivanium TI-6AL-4V alloy, sterile; REF. 9996-19-35 (Ca Terminated |
LPH | K994286 |
| Aug 31, 2006 | Zimmer Inc. Zimmer ZMR Hip System femoral body, revision, nitrided, porous, 12/14 neck taper, extended, 46 mm neck offset, cone body, size C, 55 mm build-up, tivanium TI-6AL-4V alloy, sterile; REF. 9993-19-55 (Ca Terminated |
LPH | K994286 |
| Aug 31, 2006 | Zimmer Inc. Zimmer ZMR Hip System femoral body, revision, nitrided, porous, 12/14 neck taper, extended, 46 mm neck offset, spout body, size D, 35 mm build-up, tivanium TI-6AL-4V alloy, sterile; REF. 9990-20-46 (C Terminated |
LPH | K994286 |
| Aug 31, 2006 | Zimmer Inc. Zimmer MAYO Conservative hip prosthesis femoral stem, porous, 12/14 neck taper, extra large, tivanium TI-6AL-4V alloy, sterile; REF. 8026-14 (Cat. no. 00802601400). Terminated |
LPH | K030733 |
| Aug 31, 2006 | Zimmer Inc. Zimmer MAYO Conservative hip prosthesis femoral stem, porous, 12/14 neck taper, large+, tivanium TI-6AL-4V alloy, sterile; REF. 8026-13-05 (Cat. no. 00802601305). Terminated |
LPH | K030733 |
| Aug 31, 2006 | Zimmer Inc. Zimmer Trabecular metal primary hip prosthesis femoral stem, press-fit, collarless, 12/14 neck taper - standard body -standard neck offset, size 16, 171 mm stem length, sterile, tivanium TI-6AL-4V all Terminated |
LPH | K051491 |
| Aug 31, 2006 | Zimmer Inc. Zimmer Trabecular metal primary hip prosthesis femoral stem, press-fit, collarless, 12/14 neck taper - standard body -extended neck offset, size 15, 160 mm stem length, sterile, tivanium TI-6AL-4V all Terminated |
LPH | K051491 |
| Aug 31, 2006 | Zimmer Inc. Zimmer Trabecular metal primary hip prosthesis femoral stem, press-fit, collarless, 12/14 neck taper - standard body -extended neck offset, size 14, 149 mm stem length, sterile, tivanium TI-6AL-4V all Terminated |
LPH | K051491 |
| Apr 27, 2006 | Encore Medical, Lp Porous titanium flared rim acetabular shell with three clustered holes in even sizes from 48 to 66mm, a hip prosthesis component. The lot number on the product labeling is the unique identifier of th Terminated |
LPH | K950542 |
| Mar 7, 2006 | Zimmer Inc. Zimmer Natural Hip System Collarless Stem, porous, with HA coating for cementless use only, sterile, Size 3, Right; Ref 7356-02-103. Terminated |
LPH | K920955 |
| Jan 28, 2003 | Zimmer Inc. Versys Hip System femoral stem, fiber metal midcoat, collared, 12/14 neck taper, low head center, size 16, standard body. Cat. No. 7841-16-10. Terminated |
LPH | K922071 |
| Jan 28, 2003 | Zimmer Inc. Versys Hip System femoral stem, fiber metal midcoat, collared, 12/14 neck taper, low head center, size 15, standard body. Cat. No. 7841-15-10. Terminated |
LPH | K922071 |
| Jan 28, 2003 | Zimmer Inc. Versys Hip System femoral stem, fiber metal midcoat, collared, 12/14 neck taper, low head center, size 14, standard body. Cat. No. 7841-14-10. Terminated |
LPH | K922071 |
| Jan 28, 2003 | Zimmer Inc. Versys Hip System femoral stem, fiber metal midcoat, collared, 12/14 neck taper, low head center, size 13, standard body. Cat. No. 7841-13-10. Terminated |
LPH | K922071 |
| Jan 28, 2003 | Zimmer Inc. Versys Hip System femoral stem, fiber metal midcoat, collared, 12/14 neck taper, low head center, size 12, standard body. Cat. No. 7841-12-10. Terminated |
LPH | K922071 |
| Jan 28, 2003 | Zimmer Inc. Versys Hip System femoral stem, fiber metal midcoat, collared, 12/14 neck taper, low head center, size 11, standard body. Cat. No. 7841-11-10. Terminated |
LPH | K922071 |
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