# Omnilife Science

- Location (FDA's records): Raynham, MA
- FDA decisions: 7 (2007–2021): 7 510(k) clearances
- Product codes: LZO (3), JWH (3), LPH (1)
- 510(k) review time since 2016: median 139 days, against 188 for FDA's reviews in the same codes and years (2 of 4 faster)
- Predicates its devices cite: 31 (4 its own); citations of its devices by later devices: 9 (4 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Omni Life Science, Inc.: 15 (https://510kreport.com/company/omni-life-science)
- Apex Surgical, LLC: 4 (https://510kreport.com/company/apex-surgical)
- Omnlife Science: 4 (https://510kreport.com/company/omnlife-science)
- DePuy Orthopaedics, Inc.: 3 (https://510kreport.com/company/depuy-orthopaedics)
- Biopro, Inc.: 1 (https://510kreport.com/company/biopro)

## Firms that cite its devices most
- Omni Life Science, Inc.: 4 (https://510kreport.com/company/omni-life-science)
- Total Joint Orthopedics, Inc.: 1 (https://510kreport.com/company/total-joint-orthopedics)

## Its most-cited devices
- K062489: Apex Hcla Acetabular Cup  Liners (2007), cited by 5
- K133381: Omni Arc Monoblock Hip Stem (2014), cited by 2
- K153437: Apex Revision Knee System (2015), cited by 1
- K163332: Apex Revision Knee System (2017), cited by 1

## Recent decisions
- K201611: Apex Knee System (Apr 2, 2021)
- K172467: OMNI ARC Anteverted Neck Hip Stem (Dec 21, 2017)
- K171156: OMNI Anseris Hip Stem (Aug 17, 2017)
- K163332: Apex Revision Knee System (Apr 26, 2017)
- K153437: Apex Revision Knee System (Dec 21, 2015)
- K133381: Omni Arc Monoblock Hip Stem (Mar 13, 2014)
- K062489: Apex Hcla Acetabular Cup  Liners (Aug 15, 2007)

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