Home / 510(k) Clearances / K252824

510(k) K252824

Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral Head by Signature Orthopaedics Pty, Ltd. — Product Code JDI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 12, 2026
Date Received
September 5, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Device Class
Class II
Regulation Number
888.3350
Review Panel
OR
Submission Type

Other clearances by Signature Orthopaedics Pty, Ltd.

  • 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)
  • K241690 — Logical Liner; World Liner; World Knee Patella (August 1, 2024)

Other clearances for product code JDI

  • K243571 — Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained L (July 31, 2025)
  • K240783 — Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectr (October 21, 2024)
  • K241716 — Global Modular Replacement System, Modular Replacement System, Modular Rotating (August 2, 2024)
  • K240418 — Stryker Orthopaedics Hip Systems Labeling Update (April 12, 2024)
  • K233261 — Global Modular Replacement System (December 8, 2023)
  • K222056 — Global Modular Replacement System, Modular Replacement System, Modular Rotating (January 26, 2023)
  • K220216 — C-Stem AMT LE Prosthesis (July 22, 2022)
  • K213701 — Exeter® X3® RimFit® Cup (February 1, 2022)
  • K213816 — MPO Hip Instruments (January 5, 2022)
  • K210842 — VerSys Cemented Revision/Calcar (December 10, 2021)