Home / 510(k) Clearances / K191414

510(k) K191414

EXETER Centralizer, EXETER 2.5mm Plug by Stryker Orthopaedics — Product Code JDI

K191414 is an FDA 510(k) premarket notification submitted by Stryker Orthopaedics for the device "EXETER Centralizer, EXETER 2.5mm Plug". The FDA issued a decision of Substantially Equivalent on August 28, 2019. The device falls under product code JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented), a Class II device regulated under 21 CFR 888.3350. Stryker Orthopaedics has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 28, 2019
Date Received
May 28, 2019
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 Stryker Orthopaedics

  • K211703 — Insignia Hip Stem (August 16, 2021)
  • K173499 — Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads (March 19, 2018)
  • K173849 — Triathlon Total Knee System (February 2, 2018)
  • K172326 — Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System (October 30, 2017)
  • K153345 — Stryker Orthopaedics Hip Systems Labeling Update (May 25, 2016)
  • K151264 — Restoration Anatomic Shell (August 10, 2015)
  • K143085 — Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip Instruments (February 9, 2015)
  • K143393 — Triathlon Tritanium Cone Augments (January 13, 2015)
  • K142462 — Restoration Anatomic Shell (November 14, 2014)
  • K141056 — TRIATHLON KNEE SYSTEM POSTERIOR STABILIZED COMPONENTS (August 5, 2014)

Other clearances for product code JDI

  • K253434 — OSSTM Orthopedic Salvage System (July 1, 2026)
  • K252824 — Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral Head (March 12, 2026)
  • 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)

FDA data resources