Home / 510(k) Clearances / K220495

510(k) K220495

SignaSure Dual Mobility System by Signature Orthopaedics Pty, Ltd. — Product Code MEH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 13, 2023
Date Received
February 22, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Device Class
Class II
Regulation Number
888.3353
Review Panel
OR
Submission Type

Other clearances by Signature Orthopaedics Pty, Ltd.

  • K252824 — Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral Head (March 12, 2026)
  • K253239 — Active-V Total Knee System; World Total Knee System (December 23, 2025)
  • K251771 — Cambridge Partial Knee (December 16, 2025)
  • K243021 — Longboard Revision Hip Stem (August 7, 2025)
  • K242674 — Freedom Posterior Cervical Screws (May 13, 2025)
  • K242477 — Shoulder Soft Tissue Anchors (May 12, 2025)
  • K243043 — Origin™ Cemented Hip Stem (May 2, 2025)
  • K243029 — Origin™ TT Stem (March 11, 2025)
  • K243162 — World Liner (November 25, 2024)
  • K240683 — Rx Knee System (September 11, 2024)

Other clearances for product code MEH

  • K250375 — Allure Hip Stem and Intramedullary Plugs (November 5, 2025)
  • K251166 — Mfinity Femoral System (June 13, 2025)
  • K251052 — Trivicta® Hip Stem (May 22, 2025)
  • K242315 — Resolve Modular Revision Hip Stem (May 1, 2025)
  • K243839 — Alteon® HA Femoral Stems (March 10, 2025)
  • K243162 — World Liner (November 25, 2024)
  • K241472 — Icona Hip Stem (October 3, 2024)
  • K241875 — TheRay Collared and Collarless Femoral Stem (September 13, 2024)
  • K241690 — Logical Liner; World Liner; World Knee Patella (August 1, 2024)
  • K233758 — Trivicta™ Hip Stem (March 8, 2024)