# Polynovo Biomaterials Pty, Ltd.

- Location (FDA's records): Port Melbourne, AU
- FDA decisions: 6 (2014–2025): 6 510(k) clearances
- Product codes: QSZ (5), OMP (1)
- Predicates its devices cite: 8 (4 its own); citations of its devices by later devices: 5 (4 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Polymedics Innovations, GmbH: 1 (https://510kreport.com/company/polymedics-innovations)
- Integra LifeSciences Corporation: 1 (https://510kreport.com/company/integra-lifesciences)
- Kinetic Concepts, Inc.: 1 (https://510kreport.com/company/kinetic-concepts)
- Genadyne Biotechnologies, Inc.: 1 (https://510kreport.com/company/genadyne-biotechnologies)

## Firms that cite its devices most
- Bionova Medical, Inc.: 1 (https://510kreport.com/company/bionova-medical)

## Its most-cited devices
- K172140: NovoSorb BTM Wound Dressing (2cm x 2cm), NovoSorb BTM Wound Dressing (10cm x 10cm), NovoSorb BTM Wound Dressing (10cm x 20cm), NovoSorb BTM Wound Dressing (20cm x 40cm) (2017), cited by 2
- K142879: BTM Wound Dressing (2015), cited by 1
- K221686: NovoSorb Matrix (2022), cited by 1
- K242149: NovoSorb® MTX (2025), cited by 1

## Recent decisions
- K251567: NovoSorb BTM (Jun 20, 2025)
- K242149: NovoSorb® MTX (Mar 5, 2025)
- K221686: NovoSorb Matrix (Sep 15, 2022)
- K172140: NovoSorb BTM Wound Dressing (2cm x 2cm), NovoSorb BTM Wound Dressing (10cm x 10cm), NovoSorb BTM Wound Dressing (10cm x 20cm), NovoSorb BTM Wound Dressing (20cm x 40cm) (Aug 11, 2017)
- K142879: BTM Wound Dressing (Dec 23, 2015)
- K132936: Novopore Dressing (Mar 4, 2014)

Source page: https://510kreport.com/company/polynovo-biomaterials