Home / 510(k) Clearances / K233233

510(k) K233233

EMPHASYS Femoral Stems by Depuy Ireland UC — Product Code LZO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 11, 2023
Date Received
September 28, 2023
Clearance Type
Special
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 Depuy Ireland UC

  • K253624 — INHANCE™ Reverse Shoulder System (March 11, 2026)
  • K253551 — VELYS™ Hip Navigation (March 6, 2026)
  • K253197 — ATTUNE™ Total Knee System; ATTUNE™ Revision Sleeve LPS™ Femoral Adaptors (November 19, 2025)
  • K251292 — RECLAIM Monobloc Revision Femoral Stem (May 23, 2025)
  • K243977 — EMPHASYS Acetabular System (January 22, 2025)
  • K243248 — INHANCE INTACT™ (December 23, 2024)
  • K242871 — ATTUNE™ Revision Hinge Knee (November 21, 2024)
  • K242084 — EMPHASYS Acetabular Shell with RapiTite HA (October 7, 2024)
  • K241000 — ATTUNE™ Revision Knee System; DePuy Knee Prosthesis System Universal Stem Exten (July 11, 2024)
  • K240678 — ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized (June 18, 2024)

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)