Omni Life Science, Inc.
Raynham, MA, US
Omni Life Science, Inc. appears in FDA device records in Raynham, MA. FDA records list 28 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show 47 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
2 namesFDA records resolved to Omni Life Science, Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- OMNIlife science, Inc.registration, 510(k), enforcement report, recall
- OMNIlifeScience, Inc.registration
510(k) clearance history
FDA records hold 28 510(k) clearances for Omni Life Science, Inc. between 2006 and 2021. The busiest year on record is 2010, with 5. The most recent is 2021, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2006 | 2 |
| 2007 | 1 |
| 2008 | 2 |
| 2009 | 2 |
| 2010 | 5 |
| 2011 | 5 |
| 2012 | 2 |
| 2013 | 1 |
| 2014 | 1 |
| 2015 | 1 |
| 2016 | 1 |
| 2017 | 3 |
| 2019 | 1 |
| 2021 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K201611 | Apex Knee System | JWH | Substantially Equivalent | |
| K191765 | OMNI TiN Coated Apex Knee™ System | JWH | Substantially Equivalent | |
| K172467 | OMNI ARC Anteverted Neck Hip Stem | LZO | Substantially Equivalent | |
| K171156 | OMNI Anseris Hip Stem | LZO | Substantially Equivalent | |
| K163332 | Apex Revision Knee System | JWH | Substantially Equivalent | |
| K152919 | OMNI Skirted Heads | LZO | Substantially Equivalent | |
| K153437 | Apex Revision Knee System | JWH | Substantially Equivalent | |
| K133381 | OMNI ARC MONOBLOCK HIP STEM | LZO | Substantially Equivalent | |
| K131472 | APEX KNEE MODULAR TIBIA SYSTEM | JWH | Substantially Equivalent | |
| K112891 | APEX REVISION KNEE SYSTEMS | JWH | Substantially Equivalent | |
| K113242 | APEX ARC HIP STEM | LPH | Substantially Equivalent | |
| K111062 | APEX KNEE SYSTEM, APEX ALL POLY TIBIA | JWH | Substantially Equivalent | |
| K111193 | APEX ARC HIP STEM | LZO | Substantially Equivalent | |
| K111184 | APEX PS KNEE SYSTEM - PS-C INSERT | JWH | Substantially Equivalent | |
| K110947 | APEX K1 HIP STEM | LPH | Substantially Equivalent | |
| K102578 | APEX PS KNEE SYSTEM | JWH | Substantially Equivalent | |
| K101976 | INTERFACE ACETABULAR SYSTEM, ACETABULAR INSERT +4 OFFSET | LPH | Substantially Equivalent | |
| K101451 | APEX MODULE HIP SYSTEM BIOLOX DELTA FEMORAL HEAD | LZO | Substantially Equivalent | |
| K090845 | APEX ARC HIP STEM | LZO | Substantially Equivalent | |
| K100555 | APEX-LNK ACETABULAR INSERT, E, APEX-LNK ACETABULAR INSERT, F, APEX-LNK | LPH | Substantially Equivalent | |
| K094017 | TIBIAL BASEPLATE AUGMENT MODEL KC-22118, KC-22128, KC-22138, KC-22148, KC-22158 | JWH | Substantially Equivalent | |
| K092443 | INTERFACE ACETABULAR CUP LINERS | LPH | Substantially Equivalent | |
| K082468 | APEX HIP SYSTEM BIPOLAR HEAD, MODEL H3-822XX AND H3-828YY, XX=OD IN [MM] (38-43), YY=OD IN [MM](44-60) | KWY | Substantially Equivalent | |
| K080842 | APEX KNEE SYSTEM, MODEL KC-230XY, KC-240XY [ NO HOLES, 2 HOLES] | MBH | Substantially Equivalent | |
| K073150 | APEX-LNK POLY ACETABULAR CUP LINERS | LPH | Substantially Equivalent | |
| K062489 | APEX HCLA ACETABULAR CUP LINERS | LPH | Substantially Equivalent | |
| K060072 | MONOBLOCK PRESS-FIT HIP STEM | LPH | Substantially Equivalent | |
| K060192 | APEX KNEE SYSTEM | JWH | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3013682146 | 3013682146 | OMNIlife science, Inc. | 880 N McCarthy Blvd, Milpitas, CA 95035 US | 2026 | |
| 1226188 | 3008342029 | OMNIlifeScience, Inc. | 480 Paramount Dr, Raynham, MA 02767 US | 2026 | and 1 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- HAWNeurological Stereotaxic Instrument
- OLOOrthopedic Stereotaxic Instrument
- KWYProsthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
- LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
- LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
- LWJProsthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
- MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
- MBHProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
- JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- LLZSystem, Image Processing, Radiological
- JAKSystem, X-Ray, Tomography, Computed
Recall records
Showing 25 of 47| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0237-2022 | OMNI K2 Hip Stem, Manufacturer's Product Code 130006 The OMNI K2 Hip Stem is intended for use as the femoral component of a primary total hip replacement. This femoral hip stem is intended for uncemented fixation and single use implantation. | The device is missing grit blasting on the proximal surface of the femoral stem, which may lead to the possibility of product revision in the event of undersizing. | Class II | Terminated | |
| Z-0922-2021 | SERF Novae Dual Mobility Cup Insert 49/28-ApeX-LNK Poly Liner. Intended for use with the Apex Modular Acetabular Cup for total hip replacement procedures. Product Code: H6-24928 | Acetabular Liners have a higher than acceptable oxidation limit, potential for patients to experience a higher wear rate for acetabular liners and require a revision surgery | Class II | Terminated | |
| Z-0921-2021 | SERF Novae Dual Mobility Cup Insert 47/28- ApeX-LNK Poly Liner. Intended for use with the Apex Modular Acetabular Cup for total hip replacement procedures. Product Code: H6-24728 | Acetabular Liners have a higher than acceptable oxidation limit, potential for patients to experience a higher wear rate for acetabular liners and require a revision surgery | Class II | Terminated | |
| Z-0920-2021 | SERF Novae Dual Mobility Cup Insert 51/28- ApeX-LNK Poly Liner. Intended for use with the Apex Modular Acetabular Cup for total hip replacement procedures. Product Code: H6-25128 | Acetabular Liners have a higher than acceptable oxidation limit, potential for patients to experience a higher wear rate for acetabular liners and require a revision surgery | Class II | Terminated | |
| Z-0169-2020 | OMNI Hip System Model, Catalogue, or Order Number(s): HC-00070 Intended for use as the femoral component of a primary or revision total hip replacement. | Stems missing porous coating on the device. | Class II | Terminated | |
| Z-2481-2019 | OMNIlife science, Inc. ApeX acetabular liner hip prosthesis component ApeX-LNK crosslinked Acetabular Insert, 10 deg hood; Product Code : H5-54840 | Acetabular liners failed the oxidation testing performed prior to release. They may experience a higher wear rate, leading to revision surgery. | Class II | Terminated | |
| Z-2480-2019 | OMNIlife science, Inc. ApeX acetabular liner hip prosthesis component Serf Dual Mobility Cup Insert Liner 51-28; Product code: H6-25128 | Acetabular liners failed the oxidation testing performed prior to release. They may experience a higher wear rate, leading to revision surgery. | Class II | Terminated | |
| Z-2479-2019 | OMNIlife science, Inc. ApeX acetabular liner hip prosthesis component Serf Dual Mobility Cup Liner 53-28; Product code: H6-25328 | Acetabular liners failed the oxidation testing performed prior to release. They may experience a higher wear rate, leading to revision surgery. | Class II | Terminated | |
| Z-1717-2019 | OMNIBotics iBlock Cutting Guide, 4146-1000 - Product Usage: The OMNIBotics iBlock Cutting Guide is a stainless-steel surgical instrument used during total knee arthroplasty. Specifically, the iBlock Cutting Guide is used in conjunction with the iBlock Saw Guide with the OMNIBot robotic Motor Unit, and for preparation of the bone for implant implantation. The instrument has been designed to facilitate bone preparation and implantation of the OMNI Apex Knee System. | The OMNIBotics iBlock Cutting Guide does not lock onto the iBlock Saw Guide as intended and may loosen during use. | Class II | Terminated | |
| Z-0837-2019 | OMNI K1 Broach Handle, Product Code HS-10054 | There is a potential for the inner pin of the handle to become loose and fall out. | Class II | Terminated | |
| Z-2540-2018 | OMNI Hip System, ApeX-LNK Acetabular Inserts 0 degree, 4+mm offset, Product Codes: H6-14436, H6-13928 & H6-14836 Product Usage: The Apex Hip System is intended for primary or revision total hip replacement. The femoral hip stems and acetabular cups are intended for uncemented fixation and single use implantation. The Apex Acetabular Cup liners, standard and ApeX-LNK Poly, are intended for use with the Apex Modular Acetabular Cup, in combination with the Apex Modular, Apex K2, Apex K2 mid length or Apex K1 Hip in total hip replacement procedures. The acetabular cup inserts are intended to articulate with a metal (cobalt chromium) or ceramic (alumina) femoral head. These prostheses may be used for the following conditions, as appropriate: Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis Rheumatoid arthritis Correction of functional deformity Congenital dislocation Revision procedures where other treatments or devices have failed | The Internal packaging, the pouch and patient labels are improperly labeled. | Class II | Terminated | |
| Z-1117-2018 | Apex Knee System, Tibial Baseplate Size 6 Left, non-porous - KC-2206L The Apex Knee System is intended for use as a primary or revision total knee replacement. This knee replacement system is intended for cemented fixation and single use implantation. This prosthesis may be used for the following conditions, as appropriate: Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis; Rheumatoid arthritis; Correction of functional deformity; Revision procedures where other treatments or devices have failed. | The Apex Knee System Tibial Baseplate identified has an improper expiration date marked on the external packaging. The improper expiration date (2202-03) is marked on the external packaging only. The correct lot number (2022-03) is present in the internal packaging and sterile batch documentation. | Class II | Terminated | |
| Z-0610-2017 | 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 anatomical structures and aligning the endoprostheses with the anatomical structures. It is specifically indicated for: Total Knee Arthroplasty | Incorrect lot number on outer kit | Class III | Terminated | |
| Z-2455-2015 | Offset Femoral Alignment Guide 4mm x 6; Product Code: KS 67024 Product Usage: The instrumentation has been designed to facilitate bone preparation and implantation of the Apex Knee or Apex Hip Systems. Product Usage: The instrumentation has been designed to facilitate bone preparation and implantation of the Apex Knee or Apex Hip Systems | The markings on both versions of the OFFSET FEMORAL ALIGNMENT GUIDES are incorrect. Specifically, the markings on the alignment guides are reversed from the intended position that should provide proper alignment for the offset revision stems when used with the femur. | Class II | Terminated | |
| Z-2454-2015 | Offset Femoral Alignment Guide, 2mm x 6; Product Code: KS 67022 Product Usage: The instrumentation has been designed to facilitate bone preparation and implantation of the Apex Knee or Apex Hip Systems | The markings on both versions of the OFFSET FEMORAL ALIGNMENT GUIDES are incorrect. Specifically, the markings on the alignment guides are reversed from the intended position that should provide proper alignment for the offset revision stems when used with the femur. | Class II | Terminated | |
| Z-2445-2015 | APEX INTERFACE Hemi 54X and Flared 56X, 3 Hole Acetabular Shells; Model: H5-12354, H5-11356. Product Usage: The Apex Interface Acetabular System is intended for use in combination with the Apex Modular Hip Stem in total hip replacement procedures. | The device may have improper screw hole placement due to inaccurate location of the index line. | Class II | Terminated | |
| Z-2064-2015 | Apex ARC Hip Stem, HA Coated, Size 5; Product Code: HC-21005-HA Product Usage: The Apex ARC Hip Stem is the femoral component of a primary or revision total hip replacement. This femoral hip stem is intended for press-fit application and is provided sterile for single use. They are manufactured from titanium alloy. The stem has a proximal porous coating of titanium plasma spray under a coating of hydroxyapatite (HA) | Product may breach the inner and outer sterile pouches during shipping or handling. | Class II | Terminated | |
| Z-2241-2014 | Apex Arc Hip Stem, Size 2, HA Coated; Product Code: HC-21002-HA | Staining on hip implant. | Class II | Terminated | |
| Z-2375-2012 | 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. | The Apex Knee System Modular Tibia Augment may breach the inner and outer sterile pouches, compromising the sterility | Class II | Terminated | |
| Z-2374-2012 | 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. | The Apex Knee System Modular Tibia Augment may breach the inner and outer sterile pouches, compromising the sterility | Class II | Terminated | |
| Z-2373-2012 | 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. | The Apex Knee System Modular Tibia Augment may breach the inner and outer sterile pouches, compromising the sterility | Class II | Terminated | |
| Z-2372-2012 | 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. | The Apex Knee System Modular Tibia Augment may breach the inner and outer sterile pouches, compromising the sterility | Class II | Terminated | |
| Z-2371-2012 | 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. | The Apex Knee System Modular Tibia Augment may breach the inner and outer sterile pouches, compromising the sterility | Class II | Terminated | |
| Z-2370-2012 | 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. | The Apex Knee System Modular Tibia Augment may breach the inner and outer sterile pouches, compromising the sterility | Class II | Terminated | |
| Z-1988-2009 | 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 hemiarthroplasty of the hip. | The APEX Hip System Bipolar Head implant may not properly capture the femoral head assembly of the bipolar head onto the femoral head. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain