# Omni Life Science, Inc.

- Location (FDA's records): East Taunton, MA
- FDA decisions: 21 (2006–2019): 21 510(k) clearances
- Product codes: JWH (8), LPH (7), LZO (4), KWY (1), MBH (1)
- Predicates its devices cite: 63 (17 its own); citations of its devices by later devices: 55 (17 its own)
- Recalls linked to its devices: 36 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Apex Surgical, LLC: 8 (https://510kreport.com/company/apex-surgical)
- Aesculap Implant Systems, LLC: 5 (https://510kreport.com/company/aesculap-implant-systems)
- Omnilife Science: 4 (https://510kreport.com/company/omnilife-science)
- Omnlife Science: 4 (https://510kreport.com/company/omnlife-science)
- Johnson & Johnson Professionals, Inc.: 4 (https://510kreport.com/company/johnson-johnson-professionals)
- DePuy Orthopaedics, Inc.: 4 (https://510kreport.com/company/depuy-orthopaedics)
- Plus Orthopedics: 3 (https://510kreport.com/company/plus-orthopedics)
- Zimmer, Inc.: 3 (https://510kreport.com/company/zimmer)

## Firms that cite its devices most
- Omnilife Science: 15 (https://510kreport.com/company/omnilife-science)
- Omnlife Science: 6 (https://510kreport.com/company/omnlife-science)
- Corin, Ltd.: 4 (https://510kreport.com/company/corin)
- Medacta International S.A.: 2 (https://510kreport.com/company/medacta-international)
- Depuy France S.A.S.: 2 (https://510kreport.com/company/depuy-france)
- Total Joint Orthopedics, Inc.: 2 (https://510kreport.com/company/total-joint-orthopedics)
- Corin USA: 2 (https://510kreport.com/company/corin-usa)
- Global Manufacturing Technology: 1 (https://510kreport.com/company/global-manufacturing-technology)

## Its most-cited devices
- K060192: Apex Knee System (2006), cited by 9
- K073150: Apex-LNK Poly Acetabular Cup Liners (2008), cited by 7
- K082468: Apex Hip System Bipolar Head, Model H3-822XX and H3-828YY, XX=OD in [MM] (38-43), YY=OD in [MM](44-60) (2009), cited by 6
- K100555: Apex-LNK Acetabular Insert, E, Apex-LNK Acetabular Insert, F, Apex-LNK (2010), cited by 5
- K102578: Apex PS Knee System (2011), cited by 3
- K090845: Apex Arc Hip Stem (2010), cited by 3

## Recent decisions
- K191765: OMNI TiN Coated Apex Knee™ System (Sep 25, 2019)
- K152919: OMNI Skirted Heads (Mar 10, 2016)
- K131472: Apex Knee Modular Tibia System (Oct 8, 2013)
- K112891: Apex Revision Knee Systems (Feb 29, 2012)
- K113242: Apex Arc Hip Stem (Jan 5, 2012)
- K111062: Apex Knee System, Apex All Poly Tibia (Jul 13, 2011)
- K111193: Apex Arc Hip Stem (Jun 27, 2011)
- K111184: Apex PS Knee System - PS-C Insert (Jun 22, 2011)

Source page: https://510kreport.com/company/omni-life-science