Home / 510(k) Clearances / K250450

510(k) K250450

Coated hip implants by Medacta International S.A. — Product Code LZO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 19, 2025
Date Received
February 18, 2025
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 Medacta International S.A.

  • K253328 — GMK 3D Metal Tibial Tray Extension (February 26, 2026)
  • K250644 — MSS - Monobloc stem (February 3, 2026)
  • K251043 — Mpact 3D Metal Implants Extension – DMLS Technology (January 28, 2026)
  • K252847 — NextAR Hip Platform (January 9, 2026)
  • K242603 — MyPAO SA guides (November 19, 2025)
  • K250338 — MSS - Humeral reverse liners extension (October 31, 2025)
  • K252225 — PowerKnot High Strength Sutures (September 12, 2025)
  • K251737 — NextAR(TM) Shoulder Platform (September 4, 2025)
  • K241461 — Mpact Constrained Liner (July 31, 2025)
  • K250477 — NextAR(TM) Spine (July 31, 2025)

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)
  • 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)
  • K250571 — CATALYSTEM Femoral Stems (March 28, 2025)