Home / 510(k) Clearances / K180263

510(k) K180263

EcoFit Vit E Acetabular System by Implantcast GmbH — Product Code LZO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 20, 2018
Date Received
January 30, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Implantcast GmbH

  • 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)
  • K210678 — implaFit® hip stems (August 17, 2022)

Other clearances for product code LZO

  • K252401 — implaFit® short stems (March 12, 2026)
  • K253171 — Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem) (January 15, 2026)
  • K250450 — Coated hip implants (September 19, 2025)
  • K243021 — Longboard Revision Hip Stem (August 7, 2025)
  • K251906 — Z1 Hip System (July 18, 2025)
  • K251292 — RECLAIM Monobloc Revision Femoral Stem (May 23, 2025)
  • K243927 — MobileLink Acetabular Cup System - inhouse coatings (May 16, 2025)
  • K250444 — NEXUS® Hip Stem (May 15, 2025)
  • K243043 — Origin™ Cemented Hip Stem (May 2, 2025)
  • K250834 — Zimmer Biomet Ceramic Heads (22.2mm diameter) (April 18, 2025)