Signature Orthopaedics Pty, Ltd. - FDA 510(k) Cleared Devices

Signature Orthopaedics Pty, Ltd. is an Orthopedic device manufacturer based in Lane Cove, Australia. The company designs, prototypes, and manufactures innovative surgical implants and instruments.

Signature Orthopaedics has achieved 44 FDA 510(k) clearances from 44 total submissions since 2012. All submissions have focused on Orthopedic devices, including hip stems, knee systems, spinal screws, and soft tissue anchors. The company's latest clearance in 2026 demonstrates continued regulatory activity and product innovation.

The company operates in-house capabilities for design, prototyping, testing, and manufacturing. Recent cleared devices include the Origin™ Cemented Hip Stem, Active-V Total Knee System, Cambridge Partial Knee, and Freedom Posterior Cervical Screws. Signature Orthopaedics maintains a global presence with offices across Australia, Ireland, the USA, the UK, and France.

Explore the complete list of FDA 510(k) cleared devices, product codes, and clearance dates in the database.

510(k) submissions have been managed by BioVera, Inc. as regulatory consultant.