Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads— 510(k) K173499

Clearance details

Applicant

Stryker Orthopaedics

Product code

Code JDG

Device class

Class 2

Regulation

21 CFR 888.3360

Advisory panel

Orthopedic

Date received

2017-11-13

Decision date

2018-03-19

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Mahwah, NJ, US

• K212431 — Biomet Answer/Impact/Integral Distal Centralizer/Centering Sleeve2022-02-07
• K193546 — Distal Centralizers2020-09-25
• K001984 — PROGENY FORGED COCR CEMENTED FEMORAL COMPONENT2000-09-27
• K992234 — THE TAPER-FIT TOTAL HIP SYSTEM1999-11-10
• K962002 — AURA HIP SYSTEM CALCAR REPLACEMENT FEMORAL STEM1996-08-08

• K211703 — Insignia Hip Stem2021-08-16
• K191414 — EXETER Centralizer, EXETER 2.5mm Plug2019-08-28
• K173849 — Triathlon Total Knee System2018-02-02
• K172326 — Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System2017-10-30
• K153345 — Stryker Orthopaedics Hip Systems Labeling Update2016-05-25

Injury

804

Malfunction

3,242

Total

4,046

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-0313-2022 — 28MM -4 LFIT V40 HEAD, Catalog Number 6260-9-028Class II·Ongoing·Howmedica Osteonics Corp.·20211015
• Z-0314-2022 — 28MM -4 LFIT V40 HEAD, Catalog Number 6260-9-122Class II·Ongoing·Howmedica Osteonics Corp.·20211015

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K173499.