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510(k) K252451

EPORE® XO cup system by Implantcast GmbH — Product Code OQI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 24, 2026
Date Received
August 4, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented
Device Class
Class II
Regulation Number
888.3353
Review Panel
OR
Submission Type

1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis. 3. Correction of functional deformity. 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. 5. Revision procedures where other treatment or devices have failed. Cemented and uncemented use.

Other clearances by Implantcast GmbH

  • K260037 — implantcast Packaging System Update (March 30, 2026)
  • K252401 — implaFit® short stems (March 12, 2026)
  • K241944 — AGILON® XO Shoulder Replacement System (March 10, 2025)
  • K240391 — MUTARS® femoral stem cemented 160 mm and 200 mm (October 24, 2024)
  • K234044 — ACS® LD FB Knee System (September 6, 2024)
  • K240834 — EcoFit® short stem cementless cpTi (June 3, 2024)
  • K231657 — AGILON® XO Shoulder Replacement System (February 16, 2024)
  • K232371 — Actinia® hip stems (October 19, 2023)
  • K223103 — BethaLoc® stem cementless HA (June 20, 2023)
  • K222482 — AGILON XO Shoulder System (September 28, 2022)

Other clearances for product code OQI

  • K192989 — Libertas E-XLPE Modular Liner (October 29, 2020)
  • K172833 — E-XPE Acetabular Components and U-Motion II Acetabular Cup (June 12, 2018)
  • K173583 — Exactech® Novation® and AcuMatch® E-HXL Acetabular Liners (March 12, 2018)
  • K111481 — CORIN TRINITY ACETABULAR SYSTEM ECIMA LINERS (February 6, 2012)