Home / 510(k) Clearances / K191525

510(k) K191525

KinematX Total Wrist Arthroplasty System by Extremity Medical, LLC — Product Code JWJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 4, 2020
Date Received
June 10, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained
Device Class
Class II
Regulation Number
888.3800
Review Panel
OR
Submission Type

Other clearances by Extremity Medical, LLC

  • K250536 — MetaFore Small Screw System (October 8, 2025)
  • K251128 — Extremity Medical External Fixation System (May 7, 2025)
  • K241563 — Extremity Medical External Fixation System (February 21, 2025)
  • K212297 — Omni Foot and Ankle Plating System (August 20, 2021)
  • K211261 — Axis Charcot Fixation System (May 28, 2021)
  • K201556 — Intraosseous Fixation System (July 8, 2020)
  • K192592 — Axis Plating System (November 21, 2019)
  • K181067 — AlignX Ankle Fusion System (May 23, 2018)
  • K180808 — Omni Foot Plating System (May 22, 2018)
  • K172260 — Omni Foot Plating System (November 6, 2017)

Other clearances for product code JWJ

  • K243381 — Total Wrist Arthroplasty System (TWA) (November 1, 2024)
  • K233574 — Total Wrist Arthroplasty System (TWA) (July 3, 2024)
  • K233674 — Freedom Wrist Arthroplasty System (May 30, 2024)
  • K200718 — Arthrosurface WristMotion Total Wrist Arthroplasty System (October 15, 2020)
  • K132250 — INTEGRA FREEDOM WRIST ARTHROPLASTY SYSTEM (March 24, 2014)
  • K080426 — MAESTRO WRIST FRACTURE IMPLANT (July 29, 2008)
  • K042032 — MAESTRO TOTAL WRIST (October 7, 2004)
  • K031203 — BIAX A.F. WRIST/BIAX ADVANCED FIXATION WRIST (July 14, 2003)
  • K030037 — UNIVERSAL TOTAL WRIST SYSTEM (February 5, 2003)
  • K021859 — WRIST IMPLANT (December 2, 2002)