Data / Medical devices / United States / OMNIlifeScience, Inc.
OMNIlifeScience, Inc.: FDA-registered device maker in Raynham, MA, United States, 17 510(k) clearances
OMNIlifeScience, Inc. is registered with the FDA (registration 1226188) in Raynham, MA, United States. It lists 3 device types. The FDA files 17 510(k) clearances under its listings, the newest dated July 26, 2023. 15 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 1226188
- FEI number
- 3008342029
- Address
- 480 Paramount Dr, Raynham, MA, United States, 02767
- Owner or operator
- Corin Group (9012268)
- Roles
- Manufacturer, Specification developer
- First device listed
- March 4, 2024
- Registered through
- 2026
- Brand names listed
- 4137-2050, 4137-5050, 4144-8000, 4145-1030, 4145-5003, 4145-5004, 4148-1001, 4148-1002 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Orthopedic Stereotaxic Instrument | OLO | 2 | Manufacturer | accessdata.fda.gov |
| Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | MBH | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
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 |
|---|---|---|---|---|---|---|
| July 26, 2023 | K231172 | ApolloKnee | OLO | Substantially Equivalent | Corin U.S.A. Limited | accessdata.fda.gov |
| April 2, 2021 | K201611 | Apex Knee System | JWH | Substantially Equivalent | Omnilife Science | accessdata.fda.gov |
| June 27, 2020 | K200888 | OMNIBotics Knee System | OLO | Substantially Equivalent | Corin, Ltd. | accessdata.fda.gov |
| September 25, 2019 | K191765 | OMNI TiN Coated Apex Knee System | JWH | Substantially Equivalent | Omni Life Science, Inc. | accessdata.fda.gov |
| September 1, 2017 | K163338 | OMNIBotics Knee System | OLO | Substantially Equivalent | Omnllife Science, Inc. | accessdata.fda.gov |
| April 26, 2017 | K163332 | Apex Revision Knee System | JWH | Substantially Equivalent | Omnilife Science | accessdata.fda.gov |
| December 21, 2015 | K153437 | Apex Revision Knee System | JWH | Substantially Equivalent | Omnilife Science | accessdata.fda.gov |
| February 29, 2012 | K112891 | APEX REVISION KNEE SYSTEMS | JWH | Substantially Equivalent | Omni Life Science, Inc. | accessdata.fda.gov |
| July 13, 2011 | K111062 | APEX KNEE SYSTEM, APEX ALL POLY TIBIA | JWH | Substantially Equivalent | Omni Life Science, Inc. | accessdata.fda.gov |
| June 22, 2011 | K111184 | APEX PS KNEE SYSTEM - PS-C INSERT | JWH | Substantially Equivalent | Omni Life Science, Inc. | accessdata.fda.gov |
| March 25, 2011 | K102578 | APEX PS KNEE SYSTEM | JWH | Substantially Equivalent | Omni Life Science, Inc. | accessdata.fda.gov |
| September 28, 2010 | K101994 | APEX KNEE MODULAR TIBIA SYSTEM | JWH | Substantially Equivalent | Omnlife Science | accessdata.fda.gov |
| March 5, 2010 | K094017 | TIBIAL BASEPLATE AUGMENT MODEL KC-22118, KC-22128, KC-22138, KC-22148, KC-22158 | JWH | Substantially Equivalent | Omni Life Science, Inc. | accessdata.fda.gov |
| January 21, 2010 | K090953 | TOTAL KNEE SURGETICS NAVIGATION SYSTEM WITH IBLOCK | OLO | Substantially Equivalent | Praxim Medivision, SA | accessdata.fda.gov |
| May 23, 2008 | K080842 | APEX KNEE SYSTEM, MODEL KC-230XY, KC-240XY [ NO HOLES, 2 HOLES] | MBH | Substantially Equivalent | Omni Life Science, Inc. | accessdata.fda.gov |
| February 14, 2008 | K073602 | MODIFICATION TO: APEX KNEE SYSTEM | JWH | Substantially Equivalent | Omnlife Science | accessdata.fda.gov |
| June 15, 2006 | K060192 | APEX KNEE SYSTEM | JWH | Substantially Equivalent | Omni Life Science, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| October 1, 2021 | 88890 | Class II | Terminated | 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 sin | 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. | accessdata.fda.gov |
| December 21, 2020 | 87062 | Class II | Terminated | 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 | accessdata.fda.gov |
| September 11, 2019 | 83844 | Class II | Terminated | 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. | accessdata.fda.gov |
| July 23, 2019 | 83528 | Class II | Terminated | 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. | accessdata.fda.gov |
| April 12, 2019 | 82797 | Class II | Terminated | 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 | The OMNIBotics iBlock Cutting Guide does not lock onto the iBlock Saw Guide as intended and may loosen during use. | accessdata.fda.gov |
| November 29, 2018 | 81951 | Class II | Terminated | 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. | accessdata.fda.gov |
| May 18, 2018 | 80406 | Class II | Terminated | 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 h | The Internal packaging, the pouch and patient labels are improperly labeled. | accessdata.fda.gov |
| November 20, 2017 | 79268 | Class II | Terminated | 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 fixati | 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. | accessdata.fda.gov |
| October 14, 2016 | 75499 | Class III | Terminated | 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 alig | Incorrect lot number on outer kit | accessdata.fda.gov |
| June 9, 2015 | 71470 | Class II | Terminated | 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. | accessdata.fda.gov |
| June 4, 2015 | 71461 | Class II | Terminated | 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 | The device may have improper screw hole placement due to inaccurate location of the index line. | accessdata.fda.gov |
| June 3, 2015 | 71407 | Class II | Terminated | 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-fi | Product may breach the inner and outer sterile pouches during shipping or handling. | accessdata.fda.gov |
| May 9, 2014 | 68527 | Class II | Terminated | Apex Arc Hip Stem, Size 2, HA Coated; Product Code: HC-21002-HA | Staining on hip implant. | accessdata.fda.gov |
| August 9, 2012 | 62912 | Class II | Terminated | 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 | accessdata.fda.gov |
| July 10, 2009 | 52662 | Not yet classified | Terminated | 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 hip. | The APEX Hip System Bipolar Head implant may not properly capture the femoral head assembly of the bipolar head onto the femoral head. | accessdata.fda.gov |
Compare with other makers
- All makers of Orthopedic Stereotaxic Instrument
- All makers of Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- All makers of Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Updated July 26, 2023. 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.