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510(k) K260536

Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone Cement by Depuy Ireland UC — Product Code KWL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 15, 2026
Date Received
February 17, 2026
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

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Other clearances for product code KWL

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  • 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)