Home / 510(k) Clearances / K200823

510(k) K200823

Zimmer, Inc. Hip Joint Prostheses MR Labeling I by Zimmer, Inc. — Product Code JDI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 9, 2020
Date Received
March 30, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Device Class
Class II
Regulation Number
888.3350
Review Panel
OR
Submission Type

Other clearances by Zimmer, Inc.

  • K253566 — Affixus Retrograde Femoral Nailing System (March 12, 2026)
  • K253189 — Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs) (March 9, 2026)
  • K252623 — G7® Revision Acetabular System (February 4, 2026)
  • K251098 — Identity Revision Humeral Stems (August 11, 2025)
  • K251906 — Z1 Hip System (July 18, 2025)
  • K250848 — Identity Shoulder System (July 2, 2025)
  • K243724 — Persona® Revision Knee System (Persona Revision SoluTion™ Femoral Components) (March 6, 2025)
  • K243907 — Affixus Tibial Nailing System - 4mm screws (February 12, 2025)
  • K241873 — OsseoFit Stemless Shoulder System (December 11, 2024)
  • K242543 — Persona the Personalized Knee System (Persona Ti-Nidium PPS Femurs) (November 22, 2024)

Other clearances for product code JDI

  • K243571 — Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained L (July 31, 2025)
  • K240783 — Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectr (October 21, 2024)
  • K241716 — Global Modular Replacement System, Modular Replacement System, Modular Rotating (August 2, 2024)
  • K240418 — Stryker Orthopaedics Hip Systems Labeling Update (April 12, 2024)
  • K233261 — Global Modular Replacement System (December 8, 2023)
  • K222056 — Global Modular Replacement System, Modular Replacement System, Modular Rotating (January 26, 2023)
  • K220216 — C-Stem AMT LE Prosthesis (July 22, 2022)
  • K213701 — Exeter® X3® RimFit® Cup (February 1, 2022)
  • K213816 — MPO Hip Instruments (January 5, 2022)
  • K210842 — VerSys Cemented Revision/Calcar (December 10, 2021)