Home / 510(k) Clearances / K213126

510(k) K213126

Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP Mini-Mod, Compression Hip Screw (CHS), CONQUEST FN, and cannulated screws by Smith & Nephew, Inc. — Product Code JDO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 2022
Date Received
September 27, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Fixation, Proximal Femoral, Implant
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

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  • K251627 — BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid blue); BIORAPT (June 25, 2025)
  • K243608 — TRIGEN Stable Lock Nut & Washer (June 12, 2025)
  • K250677 — LEGION Total Knee System (April 2, 2025)
  • K250571 — CATALYSTEM Femoral Stems (March 28, 2025)
  • K241666 — EVOS Pelvic and Acetabular System (February 19, 2025)
  • K243364 — TRIGEN META-TAN Trochanteric Antegrade Nail (December 9, 2024)
  • K240716 — AETOS Shoulder System Stemless Humeral Prosthesis (November 20, 2024)
  • K242711 — JOURNEY II Unicompartmental Knee System (JOURNEY II UK) (October 30, 2024)

Other clearances for product code JDO

  • K230764 — OsteoCentric Integrated Hip Fastener System (April 18, 2023)
  • K210247 — OsteoCentric Integrated Hip Fastener System (April 30, 2021)
  • K193029 — CONQUEST FN (February 28, 2020)
  • K173826 — THP Hip Fracture Plating System (February 7, 2018)
  • K172785 — CONQUEST FN (December 22, 2017)
  • K152686 — CONQUEST FN (March 17, 2016)
  • K140018 — TSP HIP FRACTURE PLATING SYSTEM (April 4, 2014)
  • K080685 — HIPLOC COMPRESSION HIP SCREW (August 15, 2008)
  • K080434 — INTERTAN CHS LOCKING PLATE SYSTEM PROX FEM PLATES/SCREW (April 10, 2008)
  • K983814 — GOTFRIED PERCUTANEOUS COMPRESSION PLATING SYSTEM (January 14, 1999)