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510(k) K233674

Freedom Wrist Arthroplasty System by Ascension Orthopedics, Inc. — Product Code JWJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 30, 2024
Date Received
November 16, 2023
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 Ascension Orthopedics, Inc.

  • K233670 — Ascension Silicone MCP; Ascension Silicone PIP (December 14, 2023)
  • K182878 — Integra Salto Total Ankle System (December 18, 2018)
  • K162153 — Integra® CAPTURE™ Screw System & Integra® Ti6® Internal Fixation System (July 14, 2017)
  • K160830 — Integra External Fixation System (July 6, 2016)
  • K152047 — INTEGRA TITAN Modular Total Shoulder System Fin-Lock Glenoid (December 23, 2015)
  • K152527 — Integra DigiFuse Cannulated Intramedullary Fusion System (October 29, 2015)
  • K151459 — Integra Total Ankle Replacement System (August 31, 2015)
  • K142413 — TITAN Modular Total Shoulder System (November 14, 2014)
  • K121826 — INTEGRA PROXIMAL HUMERAL PLATE SYSTEM (February 13, 2013)
  • K110700 — ASCENSION ATLAS HUMERAL PLATING SYSTEM (December 6, 2011)

Other clearances for product code JWJ

  • K243381 — Total Wrist Arthroplasty System (TWA) (November 1, 2024)
  • K233574 — Total Wrist Arthroplasty System (TWA) (July 3, 2024)
  • K200718 — Arthrosurface WristMotion Total Wrist Arthroplasty System (October 15, 2020)
  • K191525 — KinematX Total Wrist Arthroplasty System (March 4, 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)