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510(k) K253675

OsteoRemedies Hip Spacer System by Osteoremedies, LLC — Product Code KWL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 23, 2025
Date Received
November 21, 2025
Clearance Type
Special
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 Osteoremedies, LLC

  • K250760 — SPECTRUM GV Bone Cement (April 2, 2025)
  • K242377 — REMEDY Stemmed Knee Spacer System with All-Poly Tibial Component (October 2, 2024)
  • K231556 — SPECTRUM® GV Bone Cement (December 20, 2023)
  • K223650 — REMEDY Stemmed Knee Spacer (January 5, 2023)
  • K192995 — OsteoRemedies Hip Spacer System (January 10, 2020)
  • K191981 — REMEDY Acetabular Cup (August 23, 2019)
  • K183017 — Remedy Femoral Component 84mm, Remedy Stemmed Knee Spacer (July 25, 2019)
  • K172906 — REMEDY PLUS Hip Spacer, UNITE PLUS Bone Cement (August 29, 2018)
  • K173967 — Remedy Acetabular Cup (February 22, 2018)
  • K152267 — Remedy® Shoulder Spacer (December 15, 2015)

Other clearances for product code KWL

  • 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)
  • K143184 — Evolve UniPolar Head (March 17, 2015)
  • K112470 — 2GC HIP/KNEE MODULAR SPACER (April 5, 2012)