Home / 510(k) Clearances / K021859

510(k) K021859

WRIST IMPLANT by Avanta Orthopaedics, Inc. — Product Code JWJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 2, 2002
Date Received
June 6, 2002
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 Avanta Orthopaedics, Inc.

  • K030881 — AVANTA CARPAL FUSION PLATING SYSTEM (April 10, 2003)
  • K023604 — MODIFICATION TO RADIAL HEAD IMPLANT (November 27, 2002)
  • K013629 — FINGER JOINT PROSTHESIS (January 25, 2002)
  • K011819 — RADIAL HEAD IMPLANT (June 19, 2001)
  • K010847 — K'FIX (June 19, 2001)
  • K003033 — SCAPHIX, STAPLE, FIXATION, BONE (May 30, 2001)
  • K010786 — ULNAR HEAD IMPLANT (April 11, 2001)
  • K002644 — RADIAL HEAD IMPLANT (November 20, 2000)
  • K990596 — DISTAL RADIUS FRACTURE FIXATION PLATE SYSTEM (April 29, 1999)
  • K982268 — ULNAR HEAD IMPLANT (December 4, 1998)

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)
  • 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)