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510(k) K961051

UNIVERSAL TOTAL WRIST SYSTEM (MODIFICATION) by Kinetikos Medical, Inc. — Product Code JWJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 6, 1996
Date Received
March 11, 1996
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 Kinetikos Medical, Inc.

  • K061749 — ECLIPSE TOTAL ANKLE IMPLANT (November 22, 2006)
  • K061465 — KMI CEMENT RESTRICTOR IMPLANT (October 5, 2006)
  • K051611 — MBARESORB IMPLANT (September 6, 2005)
  • K041461 — KMI DISTAL VOLAR RADIUS PLATE SYSTEM (August 16, 2004)
  • K032806 — KATALYST RADIAL HEAD IMPLANT (April 16, 2004)
  • K040356 — KOMPRESSOR SCREW SYSTEM (March 1, 2004)
  • K024233 — KOMPRESSOR SCREW SYSTEM (February 6, 2003)
  • K030037 — UNIVERSAL TOTAL WRIST SYSTEM (February 5, 2003)
  • K023770 — K2 HEMI TOE IMPLANT SYSTEM (FORMERLY ZOBEL GREAT TOE IMPLANT SYSTEM) (December 12, 2002)
  • K020554 — MODIFICATION TO UNIVERSAL TOTAL WRIST SYSTEM (May 3, 2002)

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)