Data / Medical devices / Canada / Zimmer Biomet Canada DFE
Zimmer Biomet Canada DFE: FDA-registered device maker in Mississauga Ontario, Canada, 17 510(k) clearances and 1 PMA approval
Zimmer Biomet Canada DFE is registered with the FDA (registration 3012392319) in Mississauga Ontario, Canada. It lists 20 device types. The FDA files 17 510(k) clearances and 1 PMA approval under its listings, the newest dated December 23, 2014. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3012392319
- Address
- 2323 Argentia Road, Mississauga Ontario, Canada, L5N 5N3
- Owner or operator
- ZIMMER, INC. (1822565)
- Roles
- Exporter to the US
- First device listed
- November 16, 2007
- Registered through
- 2026
- Brand names listed
- Biomet Tibial Trays, HFN 125 DEGREE 9-13 MM, 180MM, HFN 130 DEGREE 9-13 MM, HFN RH 125 DEGREE 9-13MM, INTEGRAL CO-CR FEMORAL COMPONENT, Inter-Op Acetabular Sys.-Dursul Ace, LATERALIZED INTERGRAL POROUS PRIMARY FEMORAL COMPONENT, MALLORY-HEAD TOTAL HIP SYSTEM, MALLORY/HEAD MODULAR CALCAR WITH AND WITHOUT HA, MALLORY/HEAD TOTAL HIP SYSTEM; HA MALLORY/HEAD TOTAL HIP SYSTEM; BI-METRIC FEMORAL COMPONENTS and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 23, 2014 | K142933 | Biomet Tibial trays | JWH | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| October 27, 2014 | K141407 | VANGUARD XP FEMORAL COMPONENT(GEN II)/VANGUARD XP FEMORAL TRIAL | MBH | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| July 30, 2014 | K140883 | VANGUARD 360 OSSEOTI TIBIAL SLEEVE AUGMENT | MBH | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| December 11, 2013 | K132873 | VANGUARD XP KNEE SYSTEM | MBH | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| August 17, 2012 | K120030 | TAPERLOC COMPLETE SIZE 4MM AND XR 123 | LPH | Substantially Equivalent | Biomet Manufacturing Corp | accessdata.fda.gov |
| January 21, 2011 | K103755 | TAPERLOC COMPLETE, SIZE 5 AND 6 | KWA | Substantially Equivalent | Biomet Manufacturing Corp | accessdata.fda.gov |
| October 22, 2010 | K093293 | VANGUARD 360 REVISION KNEE SYSTEM | JWH | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| May 11, 2010 | K100238 | HFN 125 DEGREE 9-13 MM, 180MM, HFN 130 DEGREE 9-13 MM, HFN RH 125 DEGREE 9-13MM | HSB | Substantially Equivalent | DePuy Orthopaedics, Inc. | accessdata.fda.gov |
| August 11, 2003 | K030055 | MALLORY/HEAD TOTAL HIP SYSTEM; HA MALLORY/HEAD TOTAL HIP SYSTEM; BI-METRIC FEMORAL COMPONENTS | LPH | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| August 6, 2003 | K031693 | MALLORY/HEAD MODULAR CALCAR WITH AND WITHOUT HA | LPH | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| March 20, 2003 | K030501 | X-SERIES INTEGRAL LATERALIZED HIP COMPONENTS | LPH | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| June 23, 2000 | K000827 | UNICOMPARTMENTAL PATELLOFEMORAL PROSTHESIS (UPP) CEMENTED | KRR | Substantially Equivalent | Walter Abendschein, M.D. | accessdata.fda.gov |
| February 18, 1999 | K984296 | LATERALIZED INTERGRAL POROUS PRIMARY FEMORAL COMPONENT | LPH | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| February 3, 1999 | K983509 | INTER-OP ACETABULAR SYSTEM - DURASUL ACETABULAR INSERT | LPH | Substantially Equivalent | Sulzer Orthopedics, Inc. | accessdata.fda.gov |
| August 24, 1998 | K982367 | REACH HIP COMPONENT | LPH | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| September 20, 1994 | K942479 | INTEGRAL CO-CR FEMORAL COMPONENT | JDG | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| February 16, 1994 | K921181 | MALLORY-HEAD TOTAL HIP SYSTEM | LZO | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| April 21, 2004 | P010014 | OXFORD(TM) MENISCAL UNICOMPARTMENTAL KNEE SYSTEM | NRA | 107 | October 6, 2026 | accessdata.fda.gov |
Compare with other makers
- All makers of Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
- All makers of Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
- All makers of Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer
- All makers of Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
- All makers of Prosthesis, Hip, Hemi-, Femoral, Metal
- All makers of Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
Updated October 6, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.