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510(k) K173499

Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads by Stryker Orthopaedics — Product Code JDG

K173499 is an FDA 510(k) premarket notification submitted by Stryker Orthopaedics for the device "Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads". The FDA issued a decision of Substantially Equivalent on March 19, 2018. The device falls under product code JDG (Prosthesis, Hip, Femoral Component, Cemented, Metal), a Class II device regulated under 21 CFR 888.3360. Stryker Orthopaedics has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 19, 2018
Date Received
November 13, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Femoral Component, Cemented, Metal
Device Class
Class II
Regulation Number
888.3360
Review Panel
OR
Submission Type

Other clearances by Stryker Orthopaedics

  • K211703 — Insignia Hip Stem (August 16, 2021)
  • K191414 — EXETER Centralizer, EXETER 2.5mm Plug (August 28, 2019)
  • 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 JDG

  • K212431 — Biomet Answer/Impact/Integral Distal Centralizer/Centering Sleeve (February 7, 2022)
  • K193546 — Distal Centralizers (September 25, 2020)
  • K001984 — PROGENY FORGED COCR CEMENTED FEMORAL COMPONENT (September 27, 2000)
  • K992234 — THE TAPER-FIT TOTAL HIP SYSTEM (November 10, 1999)
  • K962002 — AURA HIP SYSTEM CALCAR REPLACEMENT FEMORAL STEM (August 8, 1996)
  • K955171 — NEXLOCK FEMORAL STEM (February 9, 1996)
  • K953653 — LUBINUS SP II HIP SYSTEM (November 6, 1995)
  • K953067 — HIP FRACTURE STEM FENESTRATION PLUG (August 21, 1995)
  • K945783 — ORTHOMET TITANIUM HYBRID FEMORAL STEM (May 30, 1995)
  • K951083 — PROFORM CEMENTED FEMORAL COMPONENT (May 22, 1995)

FDA data resources