510(k) K031693 ยท LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
MALLORY/HEAD MODULAR CALCAR WITH AND WITHOUT HA
| Applicant | Biomet, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Aug 6, 2003 |
| Received | Jun 2, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K031693
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 17, 2020 | Biomet, Inc. M/H MODULAR STEM, Item number 13-104756 - Product Usage: intended for use in limb salvage procedures. Terminated |
LPH | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.