Home / 510(k) Clearances / K143184

510(k) K143184

Evolve UniPolar Head by Signature Orthopaedics Pty, Ltd. — Product Code KWL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 17, 2015
Date Received
November 5, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Hemi-, Femoral, Metal
Device Class
Class II
Regulation Number
888.3360
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 KWL

  • K253675 — OsteoRemedies Hip Spacer System (December 23, 2025)
  • K252326 — InterSpace GV Hip Spacer (August 6, 2025)
  • K242865 — Synicem Hip Spacer; Synicem Knee Spacer; Synicem Shoulder Spacer (June 12, 2025)
  • K234028 — COPAL® exchange G hip spacer; COPAL® G+V (February 15, 2024)
  • K222632 — UHR Bipolar Implants, Restoration GAP II Implants (October 21, 2022)
  • K192995 — OsteoRemedies Hip Spacer System (January 10, 2020)
  • K191981 — REMEDY Acetabular Cup (August 23, 2019)
  • K172906 — REMEDY PLUS Hip Spacer, UNITE PLUS Bone Cement (August 29, 2018)
  • K173967 — Remedy Acetabular Cup (February 22, 2018)
  • K112470 — 2GC HIP/KNEE MODULAR SPACER (April 5, 2012)