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510(k) K233574

Total Wrist Arthroplasty System (TWA) by Skeletal Dynamics — Product Code JWJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 3, 2024
Date Received
November 7, 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 Skeletal Dynamics

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  • K242436 — Proximal Humerus Fixation System (November 14, 2024)
  • K243381 — Total Wrist Arthroplasty System (TWA) (November 1, 2024)
  • K241815 — Protean Fragment Plating System (September 26, 2024)
  • K242055 — Freefix Forearm Plating System (August 1, 2024)
  • K240835 — Suture Button Repair System (July 19, 2024)
  • K231447 — Double Internal Joint Stabilizer- Elbow (December 15, 2023)
  • K231188 — ALIGN Radial Head System (September 28, 2023)
  • K231623 — Distal Elbow Plating System (August 28, 2023)
  • K223318 — Internal Joint Stabilizer - Elbow (May 10, 2023)

Other clearances for product code JWJ

  • K243381 — Total Wrist Arthroplasty System (TWA) (November 1, 2024)
  • K233674 — Freedom Wrist Arthroplasty System (May 30, 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)