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510(k) K223062

World Total Knee System by Signature Orthopaedics Pty, Ltd. — Product Code JWH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 4, 2022
Date Received
September 30, 2022
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Device Class
Class II
Regulation Number
888.3560
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 JWH

  • K253793 — Materialise TKA Guide System (January 6, 2026)
  • K252974 — EMPOWR Knee (December 19, 2025)
  • K253197 — ATTUNE™ Total Knee System; ATTUNE™ Revision Sleeve LPS™ Femoral Adaptors (November 19, 2025)
  • K253314 — Freedom Infinia™ Total Knee System (October 29, 2025)
  • K253144 — Freedom® Total Knee System – Titan PCK Components (October 22, 2025)
  • K252725 — Stem Extension Line (U2 Total Knee System—PSA Type) (September 25, 2025)
  • K251554 — Materialise TKA Guide System (July 14, 2025)
  • K251776 — EMPOWR Revision Knee™ (EMPOWR Revision VVC+, e+ Tibial Insert) (July 8, 2025)
  • K251241 — EMPOWR Revision Knee™ (EMPOWR Revision Knee™ Symmetric TT Cones) (July 2, 2025)
  • K251717 — Freedom® Total Knee System – Titanium Tibial Base Plate (June 26, 2025)