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510(k) K243162

World Liner by Signature Orthopaedics Pty, Ltd. — Product Code MEH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 25, 2024
Date Received
September 30, 2024
Clearance Type
Special
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.

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  • 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)
  • K240683 — Rx Knee System (September 11, 2024)
  • K241690 — Logical Liner; World Liner; World Knee Patella (August 1, 2024)

Other clearances for product code MEH

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  • K251052 — Trivicta® Hip Stem (May 22, 2025)
  • K242315 — Resolve Modular Revision Hip Stem (May 1, 2025)
  • K243839 — Alteon® HA Femoral Stems (March 10, 2025)
  • 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)
  • K231873 — DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip P (January 19, 2024)