Company · US
Omni Life Science
FDA 510(k) clearances and medical device recalls filed under this name, 2006 to 2019. Name variants (Inc, Corp, punctuation) are merged.
21510(k) clearances (0 in 12 months)
30recalls (0 in 12 months)
30recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| KWY | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | 24 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 14 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 7 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 4 |
| MBH | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | 1 |
| OLO | Orthopedic Stereotaxic Instrument | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 25, 2019 | K191765 | OMNI TiN Coated Apex Knee System Omni Life Science, Inc. | JWH |
| Mar 10, 2016 | K152919 | OMNI Skirted Heads Omni Life Science, Inc. | LZO |
| Oct 8, 2013 | K131472 | APEX KNEE MODULAR TIBIA SYSTEM Omni Life Science, Inc. | JWH |
| Feb 29, 2012 | K112891 | APEX REVISION KNEE SYSTEMS Omni Life Science, Inc. | JWH |
| Jan 5, 2012 | K113242 | APEX ARC HIP STEM Omni Life Science, Inc. | LPH |
| Jul 13, 2011 | K111062 | APEX KNEE SYSTEM, APEX ALL POLY TIBIA Omni Life Science, Inc. | JWH |
| Jun 27, 2011 | K111193 | APEX ARC HIP STEM Omni Life Science, Inc. | LZO |
| Jun 22, 2011 | K111184 | APEX PS KNEE SYSTEM - PS-C INSERT Omni Life Science, Inc. | JWH |
| Jun 16, 2011 | K110947 | APEX K1 HIP STEM Omni Life Science, Inc. | LPH |
| Mar 25, 2011 | K102578 | APEX PS KNEE SYSTEM Omni Life Science, Inc. | JWH |
| Sep 14, 2010 | K101976 | INTERFACE ACETABULAR SYSTEM, ACETABULAR INSERT +4 OFFSET Omni Life Science, Inc. | LPH |
| Jun 22, 2010 | K101451 | APEX MODULE HIP SYSTEM BIOLOX DELTA FEMORAL HEAD Omni Life Science, Inc. | LZO |
| Apr 7, 2010 | K090845 | APEX ARC HIP STEM Omni Life Science, Inc. | LZO |
| Mar 29, 2010 | K100555 | APEX-LNK ACETABULAR INSERT, E, APEX-LNK ACETABULAR INSERT, F, APEX-LNK Omni Life Science, Inc. | LPH |
| Mar 5, 2010 | K094017 | TIBIAL BASEPLATE AUGMENT MODEL KC-22118, KC-22128, KC-22138, KC-22148, KC-22158 Omni Life Science, Inc. | JWH |
| Oct 23, 2009 | K092443 | INTERFACE ACETABULAR CUP LINERS Omni Life Science, Inc. | LPH |
| Feb 18, 2009 | K082468 | APEX HIP SYSTEM BIPOLAR HEAD, MODEL H3-822XX AND H3-828YY, XX=OD IN [MM] (38-43), YY=OD IN [MM](44-60) Omni Life Science, Inc. | KWY |
| May 23, 2008 | K080842 | APEX KNEE SYSTEM, MODEL KC-230XY, KC-240XY [ NO HOLES, 2 HOLES] Omni Life Science, Inc. | MBH |
| Feb 27, 2008 | K073150 | APEX-LNK POLY ACETABULAR CUP LINERS Omni Life Science, Inc. | LPH |
| Aug 24, 2006 | K060072 | MONOBLOCK PRESS-FIT HIP STEM Omni Life Science, Inc. | LPH |
| Jun 15, 2006 | K060192 | APEX KNEE SYSTEM Omni Life Science, Inc. | JWH |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 17, 2016 | OMNI LIFE SCIENCE OMNIBotics Tracker Kit -Model: RM-10000
The TOTAL KNEE SURGETICS Navigation System with iBlock (Now OMNIBotics) is intended for use during stereotaxic surgery to aid the surgeon in locating anatomic Terminated |
OLO | K090953 |
| Sep 13, 2012 | Omni Life Science Omnilife Science Apex Knee System Modular Tibia Augment, Size 6 x 4mm
Ref: KC-54060.
The Apex Knee System is intended for use as a primary or revision total knee replacement. Terminated |
JWH | K094017 |
| Sep 13, 2012 | Omni Life Science Omnilife Science Apex Knee System Modular Tibia Augment, Size 5 x 4mm
Ref: KC-54050.
The Apex Knee System is intended for use as a primary or revision total knee replacement. Terminated |
JWH | K094017 |
| Sep 13, 2012 | Omni Life Science Omnilife Science Apex Knee System Modular Tibia Augment, Size 4 x 4mm
Ref: KC-54040.
The Apex Knee System is intended for use as a primary or revision total knee replacement. Terminated |
JWH | K094017 |
| Sep 13, 2012 | Omni Life Science Omnilife Science Apex Knee System Modular Tibia Augment, Size 3 x 4mm
Ref: KC-54030.
The Apex Knee System is intended for use as a primary or revision total knee replacement. Terminated |
JWH | K094017 |
| Sep 13, 2012 | Omni Life Science Omnilife Science Apex Knee System Modular Tibia Augment, Size 2 x 4mm
Ref: KC-54020.
The Apex Knee System is intended for use as a primary or revision total knee replacement. Terminated |
JWH | K094017 |
| Sep 13, 2012 | Omni Life Science Omnilife Science Apex Knee System Modular Tibia Augment, Size 1 x 4mm
Ref: KC-54010.
The Apex Knee System is intended for use as a primary or revision total knee replacement. Terminated |
JWH | K094017 |
| Sep 10, 2009 | Omni Life Science Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 60 mm OD
Product Code: H3-82860.
Intended for use in combination with an Apex Hip System femoral for uncemented primary or revision hemiarthroplas Terminated |
KWY | K082468 |
| Sep 10, 2009 | Omni Life Science Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 59 mm OD
Product Code: H3-82859.
Intended for use in combination with an Apex Hip System femoral for uncemented primary or revision hemiarthroplas Terminated |
KWY | K082468 |
| Sep 10, 2009 | Omni Life Science Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 58 mm OD
Product Code: H3-82858.
Intended for use in combination with an Apex Hip System femoral for uncemented primary or revision hemiarthroplas Terminated |
KWY | K082468 |
| Sep 10, 2009 | Omni Life Science Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 57 mm OD
Product Code: H3-82857.
Intended for use in combination with an Apex Hip System femoral for uncemented primary or revision hemiarthroplas Terminated |
KWY | K082468 |
| Sep 10, 2009 | Omni Life Science Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 56 mm OD
Product Code: H3-82856.
Intended for use in combination with an Apex Hip System femoral for uncemented primary or revision hemiarthroplas Terminated |
KWY | K082468 |
| Sep 10, 2009 | Omni Life Science Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 55 mm OD
Product Code: H3-82855.
Intended for use in combination with an Apex Hip System femoral for uncemented primary or revision hemiarthroplas Terminated |
KWY | K082468 |
| Sep 10, 2009 | Omni Life Science Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 54 mm OD
Product Code: H3-82854.
Intended for use in combination with an Apex Hip System femoral for uncemented primary or revision hemiarthroplas Terminated |
KWY | K082468 |
| Sep 10, 2009 | Omni Life Science Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 53 mm OD
Product Code: H3-82853.
Intended for use in combination with an Apex Hip System femoral for uncemented primary or revision hemiarthroplas Terminated |
KWY | K082468 |
| Sep 10, 2009 | Omni Life Science Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 52 mm OD
Product Code: H3-82852.
Intended for use in combination with an Apex Hip System femoral for uncemented primary or revision hemiarthroplas Terminated |
KWY | K082468 |
| Sep 10, 2009 | Omni Life Science Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 51 mm OD
Product Code: H3-82851.
Intended for use in combination with an Apex Hip System femoral for uncemented primary or revision hemiarthroplas Terminated |
KWY | K082468 |
| Sep 10, 2009 | Omni Life Science Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 50 mm OD
Product Code: H3-82850.
Intended for use in combination with an Apex Hip System femoral for uncemented primary or revision hemiarthroplas Terminated |
KWY | K082468 |
| Sep 10, 2009 | Omni Life Science Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 49 mm OD
Product Code: H3-82849.
Intended for use in combination with an Apex Hip System femoral for uncemented primary or revision hemiarthroplas Terminated |
KWY | K082468 |
| Sep 10, 2009 | Omni Life Science Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 48 mm OD
Product Code: H3-82848.
Intended for use in combination with an Apex Hip System femoral for uncemented primary or revision hemiarthroplas Terminated |
KWY | K082468 |
| Sep 10, 2009 | Omni Life Science Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 47 mm OD
Product Code: H3-82847.
Intended for use in combination with an Apex Hip System femoral for uncemented primary or revision hemiarthroplas Terminated |
KWY | K082468 |
| Sep 10, 2009 | Omni Life Science Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 46 mm OD
Product Code: H3-82846.
Intended for use in combination with an Apex Hip System femoral for uncemented primary or revision hemiarthroplas Terminated |
KWY | K082468 |
| Sep 10, 2009 | Omni Life Science Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 45 mm OD
Product Code: H3-82845.
Intended for use in combination with an Apex Hip System femoral for uncemented primary or revision hemiarthroplas Terminated |
KWY | K082468 |
| Sep 10, 2009 | Omni Life Science Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 44 mm OD
Product Code: H3-82844.
Intended for use in combination with an Apex Hip System femoral for uncemented primary or revision hemiarthroplas Terminated |
KWY | K082468 |
| Sep 10, 2009 | Omni Life Science Apex Hip System Bipolar Head, 22.225mm ID, 43 mm OD
Product Code: H3-82243.
Intended for use in combination with an Apex Hip System femoral for uncemented primary or revision hemiarthroplasty of the Terminated |
KWY | K082468 |
| Sep 10, 2009 | Omni Life Science Apex Hip System Bipolar Head, 22.225mm ID, 42 mm OD
Product Code: H3-82242.
Intended for use in combination with an Apex Hip System femoral for uncemented primary or revision hemiarthroplasty of the Terminated |
KWY | K082468 |
| Sep 10, 2009 | Omni Life Science Apex Hip System Bipolar Head, 22.225mm ID, 41 mm OD
Product Code: H3-82241.
Intended for use in combination with an Apex Hip System femoral for uncemented primary or revision hemiarthroplasty of the Terminated |
KWY | K082468 |
| Sep 10, 2009 | Omni Life Science Apex Hip System Bipolar Head, 22.225mm ID, 40 mm OD
Product Code: H3-82240.
Intended for use in combination with an Apex Hip System femoral for uncemented primary or revision hemiarthroplasty of the Terminated |
KWY | K082468 |
| Sep 10, 2009 | Omni Life Science Apex Hip System Bipolar Head, 22.225mm ID, 39 mm OD
Product Code: H3-82239.
Intended for use in combination with an Apex Hip System femoral for uncemented primary or revision hemiarthroplasty of the Terminated |
KWY | K082468 |
| Sep 10, 2009 | Omni Life Science Apex Hip System Bipolar Head, 22.225mm ID, 38 mm OD
Product Code: H3-82238.
Intended for use in combination with an Apex Hip System femoral for uncemented primary or revision hemiarthroplasty of the Terminated |
KWY | K082468 |